Neoplasms
Conditions
Keywords
NSCLC, Dostarlimab, Belrestotug, Nelistotug
Brief summary
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess safety and pharmacokinetics and pharmacodynamics (PK/PD) of novel regimens (Dostarlimab plus belrestotug , and Dostarlimab plus belrestotug plus nelistotug) in participants with previously treated NSCLC.
Interventions
DRUGDostarlimab
Dostarlimab will be administered
DRUGBelrestotug.
Belrestotug will be administered
DRUGNelistotug
Nelistotug will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants capable of giving signed informed consent/assent. * Male or female, aged 18 years or older at the time consent is obtained. * Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and 1. Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD\[L\]1) monoclonal antibody (mAb) containing regimen. 2. Participants with known V-Raf Murine Sarcoma Viral Oncogene Homolog B (BRAF) molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration. 3. Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria * Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1. * A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable. * Adequate organ function as defined in the protocol. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply: i) Not a woman of childbearing potential (WOCBP) as defined in the protocol or ii) A WOCBP who agrees to follow the protocol defined contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. * Life expectancy of at least 12 weeks.
Exclusion criteria
Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment): 1. Docetaxel at any time. 2. Any of the investigational agents being tested in the current study. 3. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug administered. 4. Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required. * Received greater than (\>) 2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations. * Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years. * Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases. * Major surgery less than or equal to (\<=) 28 days of first dose of study treatment. * Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments. * Receiving systemic steroids (\>10 milligrams \[mg\]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment. Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication) are permitted. * Prior allogeneic/autologous bone marrow or solid organ transplantation. * Receipt of any live vaccine within 30 days prior to first dose of study treatment. * Toxicity from previous anticancer treatment that includes: 1\. Greater than or equal to (\>=) Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation. 2\. History of myocarditis of any grade during a previous treatment with immunotherapy 3. Toxicity related to prior treatment that has not resolved to \<= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be \<= Grade 2). * History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for pastpneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia. * Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions. * Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess. * History or evidence of cardiac abnormalities within the 6 months prior to enrollment which include 1. Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block. 2. Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting or bypass grafting. 3. Symptomatic pericarditis. * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Active infection requiring systemic therapy \<=7 days prior to first dose of study treatment. * Participants with known human immunodeficiency virus infection. * Participants with history of severe hypersensitivity to mAbs or hypersensitivity to any of the study treatment(s) or their excipients. * Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator. * Pregnant or lactating female participants. * Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment. * Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention. * Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. * Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment. * Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention. * Known hypersensitivity to components or excipients of dostarlimab, belrestotug, and/or nelistotug * Has received prior antibodies or drugs targeting TIGIT, CD96, PVRIG, or other therapies targeting the CD226 axis pathway
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Overall Survival (OS) | Up to approximately 107 weeks | OS is defined as the time from date of randomization to the date of death, irrespective of the cause of death. |
| Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Up to approximately 107 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. |
| Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5) | Up to 21 days | A DLT is an AE meeting criteria such as, hematologic toxicities of Grade (G) 4 neutropenia/anemia/thrombocytopenia (G3 if bleeding). Non-hematological toxicities include persistent G2 eye events, colitis/diarrhea (G2 unresolved to ≤ G1 within 7 days despite immunosuppressive therapy, G3 for ≥ 72 hours, any G4), G3 pneumonitis, rash (unresolved to ≤ G2 within 2 weeks despite treatment), hypersensitivity/IRR, liver events meeting Hy's Law criteria. G3 toxicity unresolved to ≤G1 or baseline within 3 days with supportive care, or any G4 toxicity. Exclusions include G3 events of electrolyte imbalances correctable within 72 hours without effects, nausea/vomiting/fatigue resolving within 7 days, lymphopenia, and enzyme elevations without pancreatitis. Considerations for DLTs include permanent treatment discontinuation, investigator/sponsor judgment-based events including post-observation period toxicities. |
| Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Up to approximately 97 weeks | Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized. |
| Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Up to approximately 107 weeks | Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized. |
| Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Up to approximately 97 weeks | Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature; Grade 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead. |
| Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Up to approximately 107 weeks | Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature; Grade 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead |
| Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Up to approximately 97 weeks | Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (\<80 millimeters of mercury \[mmHg\]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg); SBP: Grade 0 (\<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg); PR categories include: 'Decrease to \< 60 beats per minutes \[bpm\]', 'Change to Normal' or 'No Change', and 'Increase to \>100 bpm'; BT categories include 'Decrease to \<=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to \>=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Up to approximately 107 weeks | Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (\<80 millimeters of mercury \[mmHg\]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg); SBP: Grade 0 (\<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg); PR categories include: 'Decrease to \< 60 beats per minutes \[bpm\]', 'Change to Normal' or 'No Change', and 'Increase to \>100 bpm'; BT categories include 'Decrease to \<=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to \>=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants Who Received Concomitant Medications (Arm 4) | Up to approximately 97 weeks | Number of participants who received Concomitant medications is summarized. |
| Part 1: Number of Participants Who Received Concomitant Medications (Arm 5) | Up to approximately 107 weeks | Number of participants who received Concomitant medications is summarized. |
| Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Up to approximately 97 weeks | Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Up to approximately 107 weeks | Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Up to approximately 97 weeks | The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (\<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Up to approximately 107 weeks | The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (\<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4) | Up to approximately 97 weeks | Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (\>0%-\<10% Decrease, 10%-19% Decrease, \>=20% Decrease)', '\>=10% Decrease and \>= Lower limit of normal (LLN)', '\>=10% Decrease and \< LLN', '\>=20% Decrease and \>= LLN' and '\>=20% Decrease and \< LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | Up to approximately 107 weeks | Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (\>0%-\<10% Decrease, 10%-19% Decrease, \>=20% Decrease)', '\>=10% Decrease and \>= Lower limit of normal (LLN)', '\>=10% Decrease and \< LLN', '\>=20% Decrease and \>= LLN' and '\>=20% Decrease and \< LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Up to approximately 97 weeks | Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Up to approximately 107 weeks | Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Up to approximately 97 weeks | Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Up to approximately 107 weeks | Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Up to approximately 97 weeks | Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as XXX B YYY, WCPB YYY, where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Up to approximately 107 weeks | Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as XXX B YYY, WCPB YYY, where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline. |
| Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Up to approximately 97 weeks | Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Up to approximately 107 weeks | Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4) | Up to approximately 97 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Objective Response Rate (ORR) (Arm 5) | Up to approximately 107 weeks | ORR is defined as the percentage of participants with a best overall confirmed CR or PR at any time as per disease-specific criteria per RECIST version 1.1. CR is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). |
| Part 1: Disease Control Rate (DCR) (Arm 4) | Up to approximately 97 weeks | DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
| Part 1: Disease Control Rate (DCR) (Arm 5) | Up to approximately 107 weeks | DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
| Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4) | Up to 21 days (Cycle 1) | Blood samples were collected for pharmacokinetic analysis of Belrestotug. |
| Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Up to 21 days (Cycle 1) | Blood samples were collected for pharmacokinetic analysis of Belrestotug. |
| Part 1: Cmax and Cmin of Dostarlimab (Arm 4) | Up to 21 days (Cycle 1) | Blood samples were collected for pharmacokinetic analysis of Dostarlimab. |
| Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Up to 21 days (Cycle 1) | Blood samples were collected for pharmacokinetic analysis of Dostarlimab. |
| Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Up to 21 days (Cycle 1) | Blood samples were collected for pharmacokinetic analysis of Nelistotug. |
| Part 2: Survival Rate at 12 and 18 Months | At 12 and 18 months | Survival rate was planned to be anaysed at 12 and 18 months |
| Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) | Up to approximately 107 weeks | CR, PR, SD and PD was planned to be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. |
| Part 2: Progression-free Survival (PFS) | Up to approximately 107 weeks | PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. |
| Part 2: Objective Response Rate (ORR) | Up to approximately 107 weeks | ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per RECIST version 1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). |
| Part 2: Duration of Response (DOR) | Up to approximately 107 weeks | DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. |
| Part 2: Disease Control Rate (DCR) | Up to approximately 107 weeks | DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
| Part 2: Number of Participants With Immune-based (i) Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), and Stable Disease (iSD) | Up to approximately 107 weeks | Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST is used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable. |
| Part 2: Progression-free Survival (iPFS) | Up to approximately 107 weeks | iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. |
| Part 2: Objective Response Rate (iORR) | Up to approximately 107 weeks | iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. |
| Part 2: Duration of Response (iDOR) | Up to approximately 107 weeks | iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. |
| Part 2: Number of Participants With AEs, SAEs, Adverse Events of Special Interest (AESI), AE/SAEs Leading to Dose Modifications/Delays/Withdrawals | Up to approximately 107 weeks | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. AEs were planned to be coded using the MedDRA coding system. |
| Part 2: Number of Participants With Clinically Significant Changes in Vital Signs and Laboratory Parameters | Up to approximately 107 weeks | Clinically significant changes in vital signs were planned to be assessed. Blood samples were planned to be collected for the analysis of laboratory parameters. |
| Part 2: Cmax and Cmin for Dostarlimab | Up to approximately 107 weeks | Blood samples were planned to be collected to assess the pharmacokinetics of Dostarlimab. |
| Part 2: Cmax and Cmin for Belrestotug | Up to approximately 107 weeks | Blood samples were planned to be collected to assess the pharmacokinetics of Belrestotug. |
| Part 2: Number of Participants With Positive Anti-drug Antibodies (ADA) | Up to approximately 107 weeks | Serum samples were planned to be collected for the analysis of the presence of ADAs using validated immunoassays. |
| Part 1: Objective Response Rate (ORR) (Arm 4) | Up to approximately 97 weeks | ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). |
Countries
Canada, France, Germany, Italy, Spain, United States
Participant flow
Pre-assignment details
This is a sub-study of the master study NCT03739710.The master protocol included two parts -Part 1 (non-randomized, safety and PK/PD evaluation) and Part 2 (randomized part comparing safety and efficacy to SoC). Criteria on whether to advance a study regimen from Part 1 to Part 2 has been built into the study design. Having completed Part 1 with the allowable number of patients per protocol, the decision was taken to not enroll participants in Part 2. Part 1 was therefore considered completed.
Participants by arm
| Arm | Count |
|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. | 6 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. | 9 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. | 9 |
| Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug MD Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested. | 10 |
| Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested. | 7 |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD | 11 |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD. | 10 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 2 | 1 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Total | Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD | Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug MD | Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] |
|---|---|---|---|---|---|---|---|---|
| Age, Customized 18 to >=85 years | 6 Participants | 62 Participants | 10 Participants | 11 Participants | 7 Participants | 10 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 10 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 4 Participants | 48 Participants | 5 Participants | 8 Participants | 6 Participants | 10 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Female | 3 Participants | 26 Participants | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 36 Participants | 6 Participants | 7 Participants | 4 Participants | 5 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 6 | 5 / 9 | 7 / 9 | 7 / 10 | 4 / 7 | 7 / 11 | 6 / 10 |
| other Total, other adverse events | 6 / 6 | 9 / 9 | 8 / 9 | 10 / 10 | 6 / 7 | 11 / 11 | 9 / 10 |
| serious Total, serious adverse events | 0 / 6 | 3 / 9 | 2 / 9 | 3 / 10 | 3 / 7 | 3 / 11 | 3 / 10 |
Outcome results
Primary
Part 1: Number of Participants Requiring Dose Modifications (Arm 4)
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Time frame: Up to approximately 97 weeks
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Dose Delays | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Missed Doses | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Infusion Interruptions | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Dose Delays | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Missed Doses | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Infusion Interruptions | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Missed Doses | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Infusion Interruptions | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 4) | Dose Delays | 1 Participants |
Primary
Part 1: Number of Participants Requiring Dose Modifications (Arm 5)
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Time frame: Up to approximately 107 weeks
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Missed Doses | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Infusion Interruptions | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Dose Delays | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Missed Doses | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Infusion Interruptions | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Dose Delays | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Dose Delays | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Missed Doses | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Infusion Interruptions | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Missed Doses | 6 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Infusion Interruptions | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants Requiring Dose Modifications (Arm 5) | Dose Delays | 0 Participants |
Primary
Part 1: Number of Participants Who Received Concomitant Medications (Arm 4)
Number of participants who received Concomitant medications is summarized.
Time frame: Up to approximately 97 weeks
Population: Intent To Treat (ITT) population included all participants who were randomized to treatment regardless of whether the participants actually received study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants Who Received Concomitant Medications (Arm 4) | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants Who Received Concomitant Medications (Arm 4) | 9 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants Who Received Concomitant Medications (Arm 4) | 9 Participants |
Primary
Part 1: Number of Participants Who Received Concomitant Medications (Arm 5)
Number of participants who received Concomitant medications is summarized.
Time frame: Up to approximately 107 weeks
Population: Intent To Treat (ITT) population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants Who Received Concomitant Medications (Arm 5) | 10 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants Who Received Concomitant Medications (Arm 5) | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants Who Received Concomitant Medications (Arm 5) | 11 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants Who Received Concomitant Medications (Arm 5) | 10 Participants |
Primary
Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to approximately 107 weeks
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Any TEAEs | 10 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Any SAEs | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Any SAEs | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Any TEAEs | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Any TEAEs | 11 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Any SAEs | 3 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Any TEAEs | 9 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5) | Any SAEs | 3 Participants |
Primary
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to approximately 97 weeks
Population: Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4) | Any TEAEs | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4) | Any SAEs | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4) | Any TEAEs | 9 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4) | Any SAEs | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4) | Any TEAEs | 8 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4) | Any SAEs | 2 Participants |
Primary
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5)
A DLT is an AE meeting criteria such as, hematologic toxicities of Grade (G) 4 neutropenia/anemia/thrombocytopenia (G3 if bleeding). Non-hematological toxicities include persistent G2 eye events, colitis/diarrhea (G2 unresolved to ≤ G1 within 7 days despite immunosuppressive therapy, G3 for ≥ 72 hours, any G4), G3 pneumonitis, rash (unresolved to ≤ G2 within 2 weeks despite treatment), hypersensitivity/IRR, liver events meeting Hy's Law criteria. G3 toxicity unresolved to ≤G1 or baseline within 3 days with supportive care, or any G4 toxicity. Exclusions include G3 events of electrolyte imbalances correctable within 72 hours without effects, nausea/vomiting/fatigue resolving within 7 days, lymphopenia, and enzyme elevations without pancreatitis. Considerations for DLTs include permanent treatment discontinuation, investigator/sponsor judgment-based events including post-observation period toxicities.
Time frame: Up to 21 days
Population: DLT-evaluable participants included all participants who took at least 1 dose of study intervention and were followed for the DLT observation period or were withdrawn within the DLT observation period due to meeting the DLT criteria and no resolution/recovery per dose modifications and toxicity management guidelines.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5) | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5) | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5) | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5) | 1 Participants |
Primary
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature; Grade 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 10, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 19, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 10, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 1 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 19, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 13, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 3 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 16, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 13, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 16, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 2 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Baseline, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 7, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 22, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 7, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Baseline, Grade 1 | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 22, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 46, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Baseline, Grade 0 | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Baseline, Grade 1 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 0 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 1 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 7, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 7, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 10, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 10, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 13, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 13, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 16, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 16, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 19, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 19, Grade 1 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 22, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 22, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 25, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 25, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 28, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 28 Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 31, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 37, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 40, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 43, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 49, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 52, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 55, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 58, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 61, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 64, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 67, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 70, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 1 | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Baseline, Grade 0 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 31, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 13, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 34, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 16, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 13, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 1 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 16, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 10, Grade 1 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 37, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 19, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 10, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Baseline, Grade 1 | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 19, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 7, Grade 1 | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 22, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 7, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 22, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 1 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 25, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 25, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Treatment Discontinuation (up to 97 weeks), Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 28, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 4, Grade 0 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4) | Week 28 Grade 1 | 1 Participants |
Primary
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature; Grade 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Baseline, Grade 0 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 28, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 13, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 1 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 25, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 25, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 13, Grade 1 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Baseline, Grade 1 | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 22, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 22, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 16, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 52, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 19, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 19, Grade 0 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 16, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 49, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 2 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 49, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 46, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 0 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 1 | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 46, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 43, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 1 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 43, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 40, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 2 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 0 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 40, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 37, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 37, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 34, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 1 | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 58, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 31, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 28, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 55, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 28, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Baseline, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Baseline, Grade 1 | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 1 | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 13, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 13, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 16, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 16, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 19, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 19, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 22, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 22, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 25, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 25, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 28, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 31, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 34, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 1 | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 0 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 46, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 13, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 46, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 49, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 13, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 49, Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 1 | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 0 | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 28, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Baseline, Grade 0 | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 0 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 16, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 1 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 1 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 19, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 31, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 16, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Baseline, Grade 1 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 19, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 25, Grade 1 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 22, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 34, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 22, Grade 0 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 0 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 37, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 25, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 37, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 40, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 40, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 1 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 43, Grade 0 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 28, Grade 0 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 43, Grade 1 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 2 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 22, Grade 1 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 13, Grade 0 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 1 | 5 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 25, Grade 0 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Baseline, Grade 0 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 25, Grade 1 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 2 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 28, Grade 0 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 1 | 3 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 28, Grade 1 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 10, Grade 0 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 2 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 2 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 1 | 6 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 7, Grade 0 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 22, Grade 0 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 1 | 8 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 4, Grade 0 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Baseline, Grade 1 | 9 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 16, Grade 1 | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 16, Grade 0 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 0 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 19, Grade 0 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 19, Grade 1 | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Week 13, Grade 1 | 4 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5) | Treatment Discontinuation (up to 107 weeks), Grade 3 | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as XXX B YYY, WCPB YYY, where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.When lab values were not analyzed for some participants, the Number of Participants Analyzed will be less than the total across categories, allowing for a direct comparison without adding an Unknown or Data missing category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Free Triiodothyronine (T3), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Free Thyroxine (T4), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB Normal | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Free Triiodothyronine (T3), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB Normal | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB Low | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Free Thyroxine (T4), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB Normal | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB Normal | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB Normal | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB Normal | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Normal, WCPB Low | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Thyrotropin, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB Normal | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Calcium, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Free Triiodothyronine (T3), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Amylase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T3, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Free Thyroxine (T4), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | T4, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Troponin I, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Lipase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4) | Urea, B High, WCPB Normal | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as XXX B YYY, WCPB YYY, where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. When lab values were not analyzed for some participants, the Number of Participants Analyzed will be less than the total across categories, allowing for a direct comparison without adding an Unknown or Data missing category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB Normal | 9 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB Normal | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB Normal | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Free Triiodothyronine (T3), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB Normal | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB Low | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Free Thyroxine (T4), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB Normal | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB Normal | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Free Triiodothyronine (T3), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB Normal | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB Normal | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB Normal | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Free Thyroxine (T4), B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB Normal | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB Normal | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB Normal | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Free Triiodothyronine (T3), B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB Normal | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Free Thyroxine (T4), B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB Normal | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB Normal | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB Low | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB Normal | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB Low | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB High | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB Normal | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB High | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB Low | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB High | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB Low | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB Low | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB High | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB Normal | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB High | 3 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Low, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB Normal | 6 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B High, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB Low | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Normal, WCPB High | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB Normal | 7 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB Normal | 3 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB Normal | 8 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B Normal, WCPB High | 4 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB Normal | 6 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Normal, WCPB Low | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B High, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Urea, B High, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Normal, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Calcium, B Low, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Low, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Free Thyroxine (T4), B High, WCPB High | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB Normal | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B High, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Low, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B High, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB Low | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB Low | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB Normal | 8 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B Normal, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B Normal, WCPB Normal | 6 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB Normal | 8 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B High, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Troponin I, B High, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Normal, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Normal, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B High, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Amylase, B Low, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T3, B High, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B Low, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB Normal | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Free Triiodothyronine (T3), B High, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Thyrotropin, B Low, WCPB High | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | Lipase, B High, WCPB Low | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5) | T4, B Low, WCPB Low | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Alanine aminotransferase (ALT), Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Activated Partial Thromboplastin Time (aPTT), Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | ALT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | ALT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Aspartate aminotransferase (AST), Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AST, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AST, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | International normalized ratio (INR) increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | aPTT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | INR increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | INR increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Alkaline phosphatase (AP), Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | aPTT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AP, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AP, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Activated Partial Thromboplastin Time (aPTT), Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | aPTT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | aPTT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | International normalized ratio (INR) increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | INR increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | INR increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Alkaline phosphatase (AP), Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AP, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AP, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Alanine aminotransferase (ALT), Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | ALT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | ALT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Aspartate aminotransferase (AST), Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AST, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AST, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Alanine aminotransferase (ALT), Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AP, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AP, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | aPTT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Potassium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Alkaline phosphatase (AP), Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Activated Partial Thromboplastin Time (aPTT), Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | INR increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | INR increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | aPTT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lactate Dehydrogenase, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | International normalized ratio (INR) increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Albumin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AST, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | AST, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Bilirubin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Aspartate aminotransferase (AST), Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | ALT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Sodium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | ALT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Glucose, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Creatinine, Increase to Grade 4 | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Any Grade Increase | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Increase to Grade 4 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Any Grade Increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Any Grade Increase | 4 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AST, Any Grade Increase | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Any Grade Increase | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Increase to Grade 3 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | ALT, Any Grade Increase | 3 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Any Grade Increase | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lactate Dehydrogenase, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Any Grade Increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | AP, Any Grade Increase | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Albumin, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | INR increased, Any Grade Increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | aPTT, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Increase to Grade 3 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Sodium, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Any Grade Increase | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Creatinine, Any Grade Increase | 4 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Bilirubin, Any Grade Increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Glucose, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Potassium, Increase to Grade 4 | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Any Grade Increase | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Increase to Grade 3 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Any Grade Increase | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | White blood cell decreased, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Eosinophils, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Platelet count decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Neutrophil count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Anemia, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4) | Lymphocyte count decreased, Increase to Grade 4 | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Increase to Grade 4 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Any Grade Increase | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Any Grade Increase | 8 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Increase to Grade 3 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Increase to Grade 3 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Increase to Grade 4 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Any Grade Increase | 8 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Increase to Grade 3 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Increase to Grade 4 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Platelet count decreased, Any Grade Increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Increase to Grade 3 | 3 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Any Grade Increase | 3 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Neutrophil count decreased, Any Grade Increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Any Grade Increase | 4 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Lymphocyte count decreased, Any Grade Increase | 8 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | White blood cell decreased, Any Grade Increase | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Eosinophils, Increase to Grade 4 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5) | Anemia, Increase to Grade 4 | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (\<80 millimeters of mercury \[mmHg\]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg); SBP: Grade 0 (\<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg); PR categories include: 'Decrease to \< 60 beats per minutes \[bpm\]', 'Change to Normal' or 'No Change', and 'Increase to \>100 bpm'; BT categories include 'Decrease to \<=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to \>=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Any Grade Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Increase to Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Increase to Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Decrease to <60 bpm | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Change to Normal or No Change | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Increase to >100 bpm | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Decrease to <=35 °C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Change to Normal or No Change | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Increase to >=38 °C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Increase to >=38 °C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Decrease to <60 bpm | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Increase to >100 bpm | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Increase to Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Change to Normal or No Change | 9 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Change to Normal or No Change | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Increase to Grade 2 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Decrease to <=35 °C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Any Grade Increase | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Increase to Grade 2 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Decrease to <=35 °C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Systolic Blood Pressure, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Decrease to <60 bpm | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Change to Normal or No Change | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Change to Normal or No Change | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Increase to Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Heart Rate, Increase to >100 bpm | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Diastolic Blood Pressure, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4) | Temperature, Increase to >=38 °C | 2 Participants |
Primary
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (\<80 millimeters of mercury \[mmHg\]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg); SBP: Grade 0 (\<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg); PR categories include: 'Decrease to \< 60 beats per minutes \[bpm\]', 'Change to Normal' or 'No Change', and 'Increase to \>100 bpm'; BT categories include 'Decrease to \<=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to \>=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Decrease to <=35 C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Increase to >=38 C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Change to Normal or No Change | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Any Grade Increase | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Increase to >100 bpm | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Increase to Grade 2 | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Change to Normal or No Change | 10 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Increase to Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Increase to Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Decrease to <60 bpm | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Increase to Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Decrease to <60 bpm | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Any Grade Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Increase to >100 bpm | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Decrease to <=35 C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Change to Normal or No Change | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Any Grade Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Increase to Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Increase to >=38 C | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Change to Normal or No Change | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Change to Normal or No Change | 9 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Any Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Increase to Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Any Grade Increase | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Increase to Grade 2 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Decrease to <60 bpm | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Increase to >100 bpm | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Decrease to <=35 C | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Change to Normal or No Change | 11 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Increase to >=38 C | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Increase to Grade 3 | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Increase to Grade 2 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Any Grade Increase | 5 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Decrease to <=35 C | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Systolic Blood Pressure, Any Grade Increase | 4 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Increase to >=38 C | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Temperature, Change to Normal or No Change | 9 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Change to Normal or No Change | 7 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Decrease to <60 bpm | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Diastolic Blood Pressure, Increase to Grade 2 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5) | Heart Rate, Increase to >100 bpm | 2 Participants |
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Abnormal - NCS | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Abnormal - CS | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Normal | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Abnormal - NCS | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Abnormal - CS | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Abnormal - CS | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Normal | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Abnormal - CS | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Abnormal - NCS | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Abnormal - NCS | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Abnormal - NCS | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Abnormal - CS | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Abnormal - CS | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Abnormal - NCS | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Normal | 5 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Abnormal - NCS | 5 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Abnormal - CS | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Abnormal - NCS | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Worst-case post baseline | Normal | 4 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Normal | 7 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5) | Baseline | Abnormal - CS | 1 Participants |
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Abnormal - NCS | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Abnormal - CS | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Normal | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Abnormal - NCS | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Abnormal - CS | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Abnormal - CS | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Normal | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Normal | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Abnormal - NCS | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Abnormal - NCS | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Abnormal - CS | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Abnormal - NCS | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Abnormal - CS | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Abnormal - CS | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Normal | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Baseline | Normal | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4) | Worst-case post baseline | Abnormal - NCS | 2 Participants |
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (\>0%-\<10% Decrease, 10%-19% Decrease, \>=20% Decrease)', '\>=10% Decrease and \>= Lower limit of normal (LLN)', '\>=10% Decrease and \< LLN', '\>=20% Decrease and \>= LLN' and '\>=20% Decrease and \< LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4) | No change or any increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4) | Any Decrease | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4) | >=10% Decrease and >= LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4) | >=10% Decrease and < LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4) | >=20% Decrease and >= LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4) | >=20% Decrease and < LLN | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (\>0%-\<10% Decrease, 10%-19% Decrease, \>=20% Decrease)', '\>=10% Decrease and \>= Lower limit of normal (LLN)', '\>=10% Decrease and \< LLN', '\>=20% Decrease and \>= LLN' and '\>=20% Decrease and \< LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | No change or any increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | Any Decrease | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=10% Decrease and >= LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=10% Decrease and < LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=20% Decrease and >= LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=20% Decrease and < LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=20% Decrease and < LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | No change or any increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=10% Decrease and < LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=20% Decrease and >= LLN | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | Any Decrease | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=10% Decrease and >= LLN | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | Any Decrease | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=10% Decrease and >= LLN | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=20% Decrease and < LLN | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=10% Decrease and < LLN | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | No change or any increase | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5) | >=20% Decrease and >= LLN | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (\<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | WCPB, No Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | WCPB, Increase to Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 0 | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 0 | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | WCPB, No Grade Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | WCPB, Increase to Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 3 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 2 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | WCPB, Increase to Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | Baseline, Grade 0 | 8 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4) | WCPB, No Grade Increase | 7 Participants |
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (\<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 0 | 10 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, Increase to Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, No Grade Increase | 10 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 1 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, Increase to Grade 2 | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, No Grade Increase | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, Increase to Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 0 | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 3 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 0 | 10 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 1 | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, No Grade Increase | 11 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, Increase to Grade 2 | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, Increase to Grade 3 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 2 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, Increase to Grade 3 | 1 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, Increase to Grade 2 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 1 | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 0 | 9 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | WCPB, No Grade Increase | 8 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5) | Baseline, Grade 3 | 0 Participants |
Primary
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Up to approximately 97 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, No Change/Decreased | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, Any Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, No Change/Decreased | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, Any Increase | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, Unknown | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, No Change/Decreased | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, No Change/Decreased | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, Any Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, Any Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, Any Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, No Change/Decreased | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Occult Blood, No Change/Decreased | 7 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4) | Protein, Any Increase | 1 Participants |
Primary
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Up to approximately 107 weeks
Population: Safety Population. Only those participants with data available at specified parameters have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, Any Increase | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, Any Increase | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, Unknown | 2 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, No Change/Decreased | 3 Participants |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, No Change/Decreased | 4 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, Unknown | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, No Change/Decreased | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, Any Increase | 1 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, No Change/Decreased | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, Any Increase | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, Any Increase | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, No Change/Decreased | 5 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, Unknown | 0 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, No Change/Decreased | 6 Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, Any Increase | 6 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, Unknown | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, No Change/Decreased | 6 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, Any Increase | 2 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Occult Blood, Unknown | 0 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, No Change/Decreased | 7 Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5) | Protein, Any Increase | 1 Participants |
Primary
Part 2: Overall Survival (OS)
OS is defined as the time from date of randomization to the date of death, irrespective of the cause of death.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 1: Cmax and Cmin of Dostarlimab (Arm 4)
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Time frame: Up to 21 days (Cycle 1)
Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 4) | Cmax | 119.400 ug/mL | Standard Deviation 60.9173 |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 4) | Cmin | 33.900 ug/mL | Standard Deviation 15.3454 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 4) | Cmax | 124.278 ug/mL | Standard Deviation 40.6026 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 4) | Cmin | 34.071 ug/mL | Standard Deviation 8.5638 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 4) | Cmax | 97.433 ug/mL | Standard Deviation 34.2035 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 4) | Cmin | 22.935 ug/mL | Standard Deviation 7.9792 |
Secondary
Part 1: Cmax and Cmin of Dostarlimab (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Time frame: Up to 21 days (Cycle 1)
Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Cmax | 108.920 ug/mL | Standard Deviation 32.2323 |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Cmin | 29.290 ug/mL | Standard Deviation 12.4519 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Cmin | 34.550 ug/mL | Standard Deviation 13.296 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Cmax | 126.857 ug/mL | Standard Deviation 51.083 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Cmax | 68.751 ug/mL | Standard Deviation 43.809 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Cmin | 34.218 ug/mL | Standard Deviation 12.39 |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Cmax | 109.330 ug/mL | Standard Deviation 121.192 |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Cmax and Cmin of Dostarlimab (Arm 5) | Cmin | 39.013 ug/mL | Standard Deviation 26.8319 |
Secondary
Part 1: Cmax and Cmin of Nelistotug (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Nelistotug.
Time frame: Up to 21 days (Cycle 1)
Population: Pharmacokinetic (PK) population. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Cmax | 299.889 ug/mL | Standard Deviation 313.2561 |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Cmin | 43.689 ug/mL | Standard Deviation 13.724 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Cmin | 88.243 ug/mL | Standard Deviation 34.7201 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Cmax | 479.714 ug/mL | Standard Deviation 219.7148 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Cmax | 75.580 ug/mL | Standard Deviation 12.4318 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Cmin | 15.070 ug/mL | Standard Deviation 2.9601 |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Cmax | 554.750 ug/mL | Standard Deviation 140.7792 |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Cmax and Cmin of Nelistotug (Arm 5) | Cmin | 123.975 ug/mL | Standard Deviation 66.4588 |
Secondary
Part 1: Disease Control Rate (DCR) (Arm 4)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time frame: Up to approximately 97 weeks
Population: Intent To Treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Disease Control Rate (DCR) (Arm 4) | 17 Percentage of Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Disease Control Rate (DCR) (Arm 4) | 22 Percentage of Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Disease Control Rate (DCR) (Arm 4) | 11 Percentage of Participants |
Secondary
Part 1: Disease Control Rate (DCR) (Arm 5)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time frame: Up to approximately 107 weeks
Population: Intent To Treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Disease Control Rate (DCR) (Arm 5) | 40 Percentage of Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Disease Control Rate (DCR) (Arm 5) | 14 Percentage of Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Disease Control Rate (DCR) (Arm 5) | 27 Percentage of Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Disease Control Rate (DCR) (Arm 5) | 0 Percentage of Participants |
Secondary
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4)
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Time frame: Up to 21 days (Cycle 1)
Population: Pharmacokinetic (PK) population included all participants from the ITT Population from whom a blood sample is obtained and analyzed for PK concentration. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4) | Cmax | 88.470 Microgram/ millilitre (ug/mL) | Standard Deviation 92.2653 |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4) | Cmin | 9.412 Microgram/ millilitre (ug/mL) | Standard Deviation 5.6264 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4) | Cmax | 118.762 Microgram/ millilitre (ug/mL) | Standard Deviation 46.4217 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4) | Cmin | 22.091 Microgram/ millilitre (ug/mL) | Standard Deviation 8.4224 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4) | Cmax | 271.835 Microgram/ millilitre (ug/mL) | Standard Deviation 77.5244 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4) | Cmin | 44.350 Microgram/ millilitre (ug/mL) | Standard Deviation 24.4184 |
Secondary
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Time frame: Up to 21 days (Cycle 1)
Population: Pharmacokinetic (PK) population. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Cmax | 126.386 ug/mL | Standard Deviation 21.8676 |
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Cmin | 19.408 ug/mL | Standard Deviation 6.4103 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Cmin | 20.752 ug/mL | Standard Deviation 11.5836 |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Cmax | 137.837 ug/mL | Standard Deviation 34.539 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Cmax | 153.377 ug/mL | Standard Deviation 33.5154 |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Cmin | 153.069 ug/mL | Standard Deviation 54.345 |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Cmax | 22.967 ug/mL | Standard Deviation 7.0701 |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5) | Cmin | 21.693 ug/mL | Standard Deviation 9.2699 |
Secondary
Part 1: Objective Response Rate (ORR) (Arm 4)
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Time frame: Up to approximately 97 weeks
Population: Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Objective Response Rate (ORR) (Arm 4) | 0 Percentage of Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Objective Response Rate (ORR) (Arm 4) | 0 Percentage of Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Objective Response Rate (ORR) (Arm 4) | 0 Percentage of Participants |
Secondary
Part 1: Objective Response Rate (ORR) (Arm 5)
ORR is defined as the percentage of participants with a best overall confirmed CR or PR at any time as per disease-specific criteria per RECIST version 1.1. CR is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Time frame: Up to approximately 107 weeks
Population: Intent To Treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)] | Part 1: Objective Response Rate (ORR) (Arm 5) | 0 Percentage of Participants |
| Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)] | Part 1: Objective Response Rate (ORR) (Arm 5) | 0 Percentage of Participants |
| Arm 4: Dostarlimab + Belrestotug [High Dose (HD)] | Part 1: Objective Response Rate (ORR) (Arm 5) | 9 Percentage of Participants |
| Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD | Part 1: Objective Response Rate (ORR) (Arm 5) | 0 Percentage of Participants |
Secondary
Part 2: Cmax and Cmin for Belrestotug
Blood samples were planned to be collected to assess the pharmacokinetics of Belrestotug.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Cmax and Cmin for Dostarlimab
Blood samples were planned to be collected to assess the pharmacokinetics of Dostarlimab.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Duration of Response (DOR)
DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Duration of Response (iDOR)
iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Number of Participants With AEs, SAEs, Adverse Events of Special Interest (AESI), AE/SAEs Leading to Dose Modifications/Delays/Withdrawals
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. AEs were planned to be coded using the MedDRA coding system.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs and Laboratory Parameters
Clinically significant changes in vital signs were planned to be assessed. Blood samples were planned to be collected for the analysis of laboratory parameters.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)
CR, PR, SD and PD was planned to be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Number of Participants With Immune-based (i) Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), and Stable Disease (iSD)
Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST is used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Number of Participants With Positive Anti-drug Antibodies (ADA)
Serum samples were planned to be collected for the analysis of the presence of ADAs using validated immunoassays.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Objective Response Rate (iORR)
iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per RECIST version 1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Progression-free Survival (iPFS)
iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Progression-free Survival (PFS)
PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Time frame: Up to approximately 107 weeks
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Secondary
Part 2: Survival Rate at 12 and 18 Months
Survival rate was planned to be anaysed at 12 and 18 months
Time frame: At 12 and 18 months
Population: No participants were enrolled in Part 2 of the study. Hence, data was not collected.