Lung Cancer, Non-Small Cell
Conditions
Keywords
Non small cell lung cancer, Dostarlimab, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin
Brief summary
NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), in participants with non-squamous NSCLC without a known sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase-1 (ROS-1) mutation, BRAF V600E mutation, or other genomic aberration for which an approved targeted therapy is available. A total of approximately 240 participants will be enrolled in the study for a period of 5 years.
Interventions
DRUGDostarlimab
Dostarlimab will be administered through a 30 minute infusion at a dose of 500 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) up to a maximum of 35 cycles (each cycle of 21 days).
DRUGPembrolizumab
Pembrolizumab will be administered through a 30 minute infusion at a dose of 200 mg Q3W up to a maximum of 35 cycles (each cycle of 21 days).
DRUGChemotherapy
Pemetrexed will be administered at 500 milligram per meter square (mg/m\^2 ) IV through a 10 minute IV infusion Q3W, up to a maximum of 35 cycles (each cycle of 21 days). Cisplatin will be administered at 75 mg/m\^2 through a 30 minute IV infusion Q3W for 4 cycles (each cycle of 21 days) as per investigator decision. Carboplatin will also be administered at area under the concentration time curve 5 milligram/milliliters/minute (mg/mL/min) (maximum dose: 750 mg) through a 15 to 60 minute IV infusion Q3W for 4 cycles (each cycle of 21 days) as per investigator decision.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants and study staff may only be blinded to study treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be greater than equal to (\>=) 18 years old, must be able to understand the study procedures, and agrees to participate in the study by providing written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Participant has histologically- or cytologically-confirmed metastatic non-squamous NSCLC with documented absence of a sensitizing EGFR, ALK, ROS-1, or BRAFV600E mutation or other genomic aberration for which an approved targeted therapy is available. Mixed tumors will be categorized by the predominant cell type; if the tumor has predominantly squamous cell histology or if small cell elements are present, the participant is ineligible. * Participants must have measurable disease, that is (i.e.) presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible. * Participant has documented PD L1 status by the 22C3 pharmDx assay (Agilent/Dako). If no prior PD L1 result is available at the time of Screening, the participant can be tested locally using the stated method, or central PD L1 testing can be completed. Results are needed for stratification and must be available prior to randomization. * Participant has an ECOG performance status score of 0 or 1. * Participant has a life expectancy of at least 3 months. * Participant has adequate organ function. * Participant has recovered to Grade less than equal to (\<=)1 from any prior treatment related toxicities at the time of randomization. A participant with Grade 2 alopecia is an exception to this criterion and may qualify for this study. * Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 150 days after the last dose of study treatment: * Refrain from donating sperm plus, either: * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. * Must agree to use contraception/barrier as follows: * Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: * Is a woman of non childbearing potential (WONCBP), * Is a WOCBP, using a contraceptive method that is highly effective (with a failure rate of \<1% per year and, preferably, with low user dependency) during the Treatment Period and for at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova or oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the potential for contraceptive method failure ( for example \[e.g.\], noncompliance and recently initiated) in relationship to the first dose of study treatment. * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local guidelines) within 72 hours before the first dose of study treatment. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Exclusion criteria
* Participant has received prior systemic therapy for the treatment of metastatic NSCLC. Participants who have received neoadjuvant or adjuvant chemotherapy are eligible if the neoadjuvant/adjuvant therapy was completed at least 12 months prior to the development of metastatic disease. * Participant has received prior therapy with a PD (L)1 or PD L2 inhibitor, a cytotoxic T lymphocyte associated protein 4 (CTLA 4) inhibitor, a T cell immunoglobulin and mucin domain containing 3 (TIM 3) inhibitor, or any other immunotherapy agent (eg, OX40) for the treatment of cancer. * Participant has received radiation to the lung that is \>30 Gray (Gy) within 6 months of the first dose of study treatment. * Participant has completed palliative radiotherapy within 7 days of the first dose of study treatment. * Participant is ineligible if any of the following hepatic characteristics are present: * Alanine aminotransferase (ALT) \>2.5 times upper limit of normal (ULN) without liver metastases/tumor infiltration. * ALT \>5 times ULN with liver metastases/tumor infiltration. * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%) * Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per Investigator assessment) * Participant has a corrected QT interval (QTc) \>450 milliseconds (msec) (or QTc \>480 msec for participants with bundle branch block). * Participant has had major surgery within 3 weeks of the first dose of study treatment or has not adequately recovered from any AEs (Grade \<=1) and/or complications from any major surgery. Surgical implantation of a port catheter is not exclusionary. * Participant has an additional malignancy or a history of prior malignancy, with the exception of adequately treated basal or squamous skin cancer, cervical carcinoma in situ, or bladder carcinoma in situ without evidence of disease, or had a malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy. * Participant has known active brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 2 weeks before study entry and must be off corticosteroids within 3 days prior to the first dose of study treatment. Stable brain metastases by this definition should be established prior to the first dose of study treatment. Participants with known untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesions \>1.5 centimeters \[cm\]) may participate, but will require regular imaging of the brain as a site of disease. * Participant has tested positive for the presence of hepatitis B surface antigen or has a positive hepatitis C antibody test result at Screening, or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, participants who test positive for the presence of hepatitis B core antibody should also be excluded. * Participant has an active infection requiring systemic therapy within 1 week prior to the anticipated first dose of study treatment. * Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies). * Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Participant has received systemic steroid therapy within 3 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed. * Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoraco or paracentesis) is eligible. * Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of oral or IV glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary. * Participant has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study treatment, or indicate it is not in the best interest of the participant to participate, in the opinion of the Investigator. * Participant has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis. * Participant has preexisting peripheral neuropathy that is Grade \>=2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 criteria. * Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus are permitted. * Participant does not meet requirements per local prescribing guidelines for receiving treatment with either pemetrexed and cisplatin or carboplatin. * Participant has sensitivity to any of the study treatments, or components thereof, or a history of drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation. * Participant is unable to interrupt aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs), other than an aspirin dose \<=1.3 gram (g) per day, for a 5 day period (8 day period for long acting agents, such as piroxicam).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 20 months | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Up to approximately 46 months | PFS was defined as the time from the date of randomization to the date of disease progression (PD) or death by any cause, whichever occurs first. PFS was evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 based on Investigator assessment. PD 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). |
| Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation | Up to 46 months | AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. Number of participants with TEAEs, TEAEs leading to death, and TEAEs leading to treatment discontinuation are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary). |
| Number of Participants With Treatment Emergent Immune-related Adverse Event (irAE) | Up to 46 months | The irAEs are events which are severe or fatal and can occur in participants treated with monoclonal antibodies directed against immune checkpoints, including pembrolizumab and dostarlimab. While irAEs (eg, diarrhea/colitis, pneumonitis, nephritis, hypophysitis, adrenalitis, thyroiditis, severe skin reactions, uveitis, myocarditis, and hepatotoxicity) usually occur during treatment, symptoms can also manifest after discontinuation of treatment. AEs were coded using the MedDRA dictionary. |
| Number of Participants With Serious AEs | Up to approximately 46 months | An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the above outcomes. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary. |
| Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 46 months | Normal ranges were 30 to 110 units per liter (U/L) (Amylase); 4. 5 to 5. 6 milligram/deciliters (mg/dL) (Calcium); 96 to 100 milliequivalents (mEq)/ L (Chloride); 2. 5 to 4.5 mg/dL (Phosphate); 6 to 8.3 grams/L (protein); 6 to 24 millimoles/L (Urea) and 7 to 20 mg/dL (Urea nitrogen). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in To Normal or No Change category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%. |
| Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 46 months | Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils); 41 to 50 percentage of red blood cells (RBC) in blood (hematocrit); 80-100 femtoliters (fl) (erythrocytes \[referred as Ery\] mean corpuscular volume (EMCV)); 2 to 8 percentage of WBC (monocytes); and Women: 4.2 to 5.4 million RBC/ microliter (mcL) of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in To Normal or No Change category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%. |
| Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Up to approximately 46 months | Urine samples were collected to assess urine Bilirubin, glucose, ketones, Leukocyte Esterase, Nitrite, occult blood and Protein using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as No Change/Decreased, Increase to TRACE, Increase to +, Increase to ++, Increase to +++ and Increase to ++++. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Up to approximately 46 months | Blood samples were collected for the assessment Free Triiodothyronine (T3) and Free Thyroxine (T4). |
| Overall Survival (OS) | Up to approximately 46 months | OS was defined as the time from the date of randomization to the date of death by any cause. |
| Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Up to approximately 46 months | Blood samples were collected for the assessment of Triiodothyronine (T3) and Thyroxine (T4). |
| Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Up to approximately 46 months | DBP and SBP were measured in a semi-supine position after 5 minutes rest. Grades were derived based on numeric criteria as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Systolic Blood Pressure (SBP): Grade 0 (\<120 Millimetre of mercury (mmHg)), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). Diastolic Blood Pressure (DBP): Grade 0 (\<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Only those participants with grade increase have been presented. Participants with missing Baseline values were assumed to have a Baseline value of G0. |
| Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI) | Up to approximately 46 months | Normal range of Pulse Rate was 60 to 100 beats/min. Participants were counted in worst case category that their value changes to low, to within \[w/in\] Range or No Change \[NC\] or high, unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in To Normal or No Change category. |
| Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | Up to approximately 46 months | Performance status was assessed using the ECOG scale (Grade 0-5). Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters | Baseline (Day 1), Cycle 1 Day 1, and end of treatment (Up to approximately 46 months) | Participants were in a supine or semi recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs were recorded. Single 12-lead ECG was recorded using an ECG machine. PR, QRS, QT, QTcF, and RR intervals were recorded |
| Mean Change From Baseline in ECG Mean Heart Rate | Baseline (Day 1), Cycle 1 Day 1, and end of treatment (Up to approximately 46 months) | Participants were in a supine or semi recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs were recorded. Single 12-lead ECG was recorded using an ECG machine. Mean Heart rate were recorded. |
| Number Participant Who Used Concomitant Medications | Up to approximately 46 months | Number of participants received concomitant medications were summarized. |
| Change From Baseline in Thyroid Function: Thyrotropin (TSH) | Up to approximately 46 months | Blood samples were collected for the assessment of Thyroid Function Thyrotropin (TSH). |
Countries
Argentina, Brazil, Chile, France, Germany, Italy, Poland, Romania, South Korea, Spain, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dostarlimab + Chemotherapy Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion. | 121 |
| Pembrolizumab + Chemotherapy Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter\^2 (m\^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m\^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion. | 122 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Study terminated by sponsor | 37 | 23 |
| Overall Study | Withdrawal by Subject | 2 | 7 |
Baseline characteristics
| Characteristic | Dostarlimab + Chemotherapy | Pembrolizumab + Chemotherapy | Total |
|---|---|---|---|
| Age, Continuous | 63.4 YEARS STANDARD_DEVIATION 9.43 | 65.4 YEARS STANDARD_DEVIATION 8.51 | 64.4 YEARS STANDARD_DEVIATION 9.02 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 23 Participants | 21 Participants | 44 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Multiple | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Not Reported | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 87 Participants | 84 Participants | 171 Participants |
| Sex: Female, Male Female | 36 Participants | 45 Participants | 81 Participants |
| Sex: Female, Male Male | 85 Participants | 77 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 80 / 121 | 91 / 122 |
| other Total, other adverse events | 117 / 121 | 114 / 122 |
| serious Total, serious adverse events | 51 / 121 | 61 / 122 |
Outcome results
Primary
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline).
Time frame: Up to approximately 20 months
Population: Intent-to-treat (ITT) population included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dostarlimab + Chemotherapy | Objective Response Rate (ORR) | 46 Percentage of Participants |
| Pembrolizumab + Chemotherapy | Objective Response Rate (ORR) | 37 Percentage of Participants |
80% CI: [1.46, 17.18]
Secondary
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)
Blood samples were collected for the assessment Free Triiodothyronine (T3) and Free Thyroxine (T4).
Time frame: Up to approximately 46 months
Population: Safety population. Only those participants with data available at specified categories have been analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to End of Treatment | -0.64275 Picomoles per liter(pmol/L) | Standard Deviation 2.184114 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 2 Day 1 | -0.12423 Picomoles per liter(pmol/L) | Standard Deviation 2.071042 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 2 Day 1 | -0.35227 Picomoles per liter(pmol/L) | Standard Deviation 4.257866 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 18 Day 1 | -0.37234 Picomoles per liter(pmol/L) | Standard Deviation 2.414983 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 4 Day 1 | 0.04265 Picomoles per liter(pmol/L) | Standard Deviation 6.245167 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 8 Day 1 | 0.11483 Picomoles per liter(pmol/L) | Standard Deviation 2.738875 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 6 Day 1 | -0.10229 Picomoles per liter(pmol/L) | Standard Deviation 5.41801 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 20 Day 1 | -0.37506 Picomoles per liter(pmol/L) | Standard Deviation 2.495642 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 8 Day 1 | -1.02504 Picomoles per liter(pmol/L) | Standard Deviation 6.168755 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, Baseline | 4.48026 Picomoles per liter(pmol/L) | Standard Deviation 1.638746 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 10 Day 1 | -1.15108 Picomoles per liter(pmol/L) | Standard Deviation 5.586383 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 22 Day 1 | -0.36400 Picomoles per liter(pmol/L) | Standard Deviation 2.759103 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 12 Day 1 | -0.16670 Picomoles per liter(pmol/L) | Standard Deviation 6.081753 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 10 Day 1 | -0.25993 Picomoles per liter(pmol/L) | Standard Deviation 2.187046 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 14 Day 1 | 0.32703 Picomoles per liter(pmol/L) | Standard Deviation 6.114475 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 24 Day 1 | -0.69144 Picomoles per liter(pmol/L) | Standard Deviation 2.662922 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 16 Day 1 | -0.45337 Picomoles per liter(pmol/L) | Standard Deviation 4.84044 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 4 Day 1 | -0.00187 Picomoles per liter(pmol/L) | Standard Deviation 2.206972 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 18 Day 1 | 0.07645 Picomoles per liter(pmol/L) | Standard Deviation 5.524789 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 26 Day 1 | 0.01392 Picomoles per liter(pmol/L) | Standard Deviation 1.331466 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 20 Day 1 | -0.41084 Picomoles per liter(pmol/L) | Standard Deviation 5.01327 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 12 Day 1 | -0.04347 Picomoles per liter(pmol/L) | Standard Deviation 2.817465 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 22 Day 1 | -0.65956 Picomoles per liter(pmol/L) | Standard Deviation 5.562802 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 28 Day 1 | -0.05502 Picomoles per liter(pmol/L) | Standard Deviation 1.094085 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 24 Day 1 | -0.71092 Picomoles per liter(pmol/L) | Standard Deviation 6.314352 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, Baseline | 16.33405 Picomoles per liter(pmol/L) | Standard Deviation 4.294246 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 26 Day 1 | -0.89968 Picomoles per liter(pmol/L) | Standard Deviation 5.2463 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 30 Day 1 | 0.11929 Picomoles per liter(pmol/L) | Standard Deviation 1.151771 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 28 Day 1 | -0.89658 Picomoles per liter(pmol/L) | Standard Deviation 5.48913 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 14 Day 1 | -0.61895 Picomoles per liter(pmol/L) | Standard Deviation 2.558169 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 30 Day 1 | -1.46126 Picomoles per liter(pmol/L) | Standard Deviation 4.811596 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 32 Day 1 | 0.54114 Picomoles per liter(pmol/L) | Standard Deviation 1.043916 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 32 Day 1 | -1.81377 Picomoles per liter(pmol/L) | Standard Deviation 5.474197 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 6 Day 1 | -0.15030 Picomoles per liter(pmol/L) | Standard Deviation 2.128584 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 34 Day 1 | -1.52641 Picomoles per liter(pmol/L) | Standard Deviation 6.379163 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 34 Day 1 | 0.62534 Picomoles per liter(pmol/L) | Standard Deviation 0.957105 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to End of Treatment | 0.26660 Picomoles per liter(pmol/L) | Standard Deviation 3.882315 |
| Dostarlimab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 16 Day 1 | -0.44645 Picomoles per liter(pmol/L) | Standard Deviation 2.274173 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to End of Treatment | 0.46964 Picomoles per liter(pmol/L) | Standard Deviation 3.310829 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, Baseline | 4.48540 Picomoles per liter(pmol/L) | Standard Deviation 1.066597 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 2 Day 1 | -0.24330 Picomoles per liter(pmol/L) | Standard Deviation 1.026993 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 4 Day 1 | -0.11796 Picomoles per liter(pmol/L) | Standard Deviation 1.41319 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 6 Day 1 | -0.37705 Picomoles per liter(pmol/L) | Standard Deviation 1.117516 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 8 Day 1 | -0.43073 Picomoles per liter(pmol/L) | Standard Deviation 1.123017 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 10 Day 1 | -0.23819 Picomoles per liter(pmol/L) | Standard Deviation 1.273369 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 12 Day 1 | 5.82171 Picomoles per liter(pmol/L) | Standard Deviation 34.328615 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 14 Day 1 | -0.33501 Picomoles per liter(pmol/L) | Standard Deviation 1.597219 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 16 Day 1 | -0.36614 Picomoles per liter(pmol/L) | Standard Deviation 1.108135 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 18 Day 1 | -0.12607 Picomoles per liter(pmol/L) | Standard Deviation 1.337185 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 20 Day 1 | -0.26936 Picomoles per liter(pmol/L) | Standard Deviation 1.237097 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 22 Day 1 | -0.17980 Picomoles per liter(pmol/L) | Standard Deviation 1.018812 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 24 Day 1 | -0.18380 Picomoles per liter(pmol/L) | Standard Deviation 0.736262 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 26 Day 1 | -0.39401 Picomoles per liter(pmol/L) | Standard Deviation 0.669173 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 28 Day 1 | -0.28233 Picomoles per liter(pmol/L) | Standard Deviation 0.880805 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 30 Day 1 | -0.19119 Picomoles per liter(pmol/L) | Standard Deviation 0.911551 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 32 Day 1 | 0.03556 Picomoles per liter(pmol/L) | Standard Deviation 1.067239 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to Cycle 34 Day 1 | -0.32236 Picomoles per liter(pmol/L) | Standard Deviation 0.774334 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, Baseline | 15.93013 Picomoles per liter(pmol/L) | Standard Deviation 3.436512 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 2 Day 1 | 0.21349 Picomoles per liter(pmol/L) | Standard Deviation 3.541952 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 4 Day 1 | 0.08969 Picomoles per liter(pmol/L) | Standard Deviation 4.015042 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 6 Day 1 | -0.58695 Picomoles per liter(pmol/L) | Standard Deviation 3.404576 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 8 Day 1 | 0.27944 Picomoles per liter(pmol/L) | Standard Deviation 3.877876 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 10 Day 1 | 0.08349 Picomoles per liter(pmol/L) | Standard Deviation 3.613602 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 12 Day 1 | 4.71828 Picomoles per liter(pmol/L) | Standard Deviation 27.489015 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 14 Day 1 | -0.45213 Picomoles per liter(pmol/L) | Standard Deviation 4.196576 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 16 Day 1 | 0.24537 Picomoles per liter(pmol/L) | Standard Deviation 3.472618 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 18 Day 1 | 0.47690 Picomoles per liter(pmol/L) | Standard Deviation 1.984139 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 20 Day 1 | 0.37830 Picomoles per liter(pmol/L) | Standard Deviation 3.413511 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 22 Day 1 | 0.45462 Picomoles per liter(pmol/L) | Standard Deviation 2.84191 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 24 Day 1 | 0.31032 Picomoles per liter(pmol/L) | Standard Deviation 2.653193 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 26 Day 1 | 0.23139 Picomoles per liter(pmol/L) | Standard Deviation 3.443957 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 28 Day 1 | 1.10907 Picomoles per liter(pmol/L) | Standard Deviation 2.849631 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 30 Day 1 | -0.21286 Picomoles per liter(pmol/L) | Standard Deviation 3.203649 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 32 Day 1 | 0.13236 Picomoles per liter(pmol/L) | Standard Deviation 3.519557 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Thyroxine, Free, CFB to Cycle 34 Day 1 | 0.45041 Picomoles per liter(pmol/L) | Standard Deviation 2.435328 |
| Pembrolizumab + Chemotherapy | Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4) | Triiodothyronine, Free, CFB to End of Treatment | -0.40528 Picomoles per liter(pmol/L) | Standard Deviation 1.086922 |
Secondary
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)
Blood samples were collected for the assessment of Triiodothyronine (T3) and Thyroxine (T4).
Time frame: Up to approximately 46 months
Population: Safety population. Only those participants with data available at specified categories have been analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 4 Day 1 | 10.16002 Nanomoles per liter (nmol/L) | Standard Deviation 47.746764 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Triiodothyronine, CFB to Cycle 2 Day 1 | 0.06903 Nanomoles per liter (nmol/L) | Standard Deviation 0.172873 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Triiodothyronine, CFB to Cycle 4 Day 1 | -0.41878 Nanomoles per liter (nmol/L) | Standard Deviation 0.353613 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Triiodothyronine, CFB to Cycle 6 Day 1 | -0.21476 Nanomoles per liter (nmol/L) | — |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, Baseline | 72.72912 Nanomoles per liter (nmol/L) | Standard Deviation 46.845564 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 2 Day 1 | 16.06393 Nanomoles per liter (nmol/L) | Standard Deviation 38.489073 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 6 Day 1 | 9.83083 Nanomoles per liter (nmol/L) | Standard Deviation 30.658114 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 8 Day 1 | 21.85010 Nanomoles per liter (nmol/L) | Standard Deviation 44.24277 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 10 Day 1 | 32.19186 Nanomoles per liter (nmol/L) | Standard Deviation 41.441071 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 12 Day 1 | 23.45510 Nanomoles per liter (nmol/L) | Standard Deviation 36.165686 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 14 Day 1 | 14.79794 Nanomoles per liter (nmol/L) | Standard Deviation 35.614508 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 16 Day 1 | 21.23230 Nanomoles per liter (nmol/L) | Standard Deviation 38.220665 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 18 Day 1 | 18.35801 Nanomoles per liter (nmol/L) | Standard Deviation 31.436316 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 20 Day 1 | 26.94600 Nanomoles per liter (nmol/L) | Standard Deviation 47.915257 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 22 Day 1 | 22.73866 Nanomoles per liter (nmol/L) | Standard Deviation 34.20289 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 24 Day 1 | 24.31027 Nanomoles per liter (nmol/L) | Standard Deviation 45.963345 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 26 Day 1 | 32.22436 Nanomoles per liter (nmol/L) | Standard Deviation 62.122105 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 28 Day 1 | 21.13316 Nanomoles per liter (nmol/L) | Standard Deviation 46.351292 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 30 Day 1 | 19.12904 Nanomoles per liter (nmol/L) | Standard Deviation 53.351526 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 32 Day 1 | 19.99271 Nanomoles per liter (nmol/L) | Standard Deviation 58.500079 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 34 Day 1 | -4.97280 Nanomoles per liter (nmol/L) | Standard Deviation 8.622499 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to End of Treatment | 11.06954 Nanomoles per liter (nmol/L) | Standard Deviation 35.792455 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Triiodothyronine, Baseline | 1.68399 Nanomoles per liter (nmol/L) | Standard Deviation 0.308404 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 4 Day 1 | 12.22592 Nanomoles per liter (nmol/L) | Standard Deviation 30.578995 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 34 Day 1 | 0.01300 Nanomoles per liter (nmol/L) | — |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 14 Day 1 | 0.64908 Nanomoles per liter (nmol/L) | Standard Deviation 12.623292 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Triiodothyronine, Baseline | 1.48287 Nanomoles per liter (nmol/L) | Standard Deviation 0.526037 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 30 Day 1 | 13.09008 Nanomoles per liter (nmol/L) | Standard Deviation 11.862148 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Triiodothyronine, CFB to Cycle 2 Day 1 | -0.58292 Nanomoles per liter (nmol/L) | — |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 16 Day 1 | 7.86174 Nanomoles per liter (nmol/L) | Standard Deviation 18.910608 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 26 Day 1 | 35.71425 Nanomoles per liter (nmol/L) | Standard Deviation 12.285627 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 18 Day 1 | 7.37470 Nanomoles per liter (nmol/L) | Standard Deviation 8.635752 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, Baseline | 85.29069 Nanomoles per liter (nmol/L) | Standard Deviation 38.027652 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to End of Treatment | 4.67311 Nanomoles per liter (nmol/L) | Standard Deviation 29.791225 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 2 Day 1 | -3.12689 Nanomoles per liter (nmol/L) | Standard Deviation 11.5441 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 20 Day 1 | 16.06215 Nanomoles per liter (nmol/L) | Standard Deviation 18.656008 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 6 Day 1 | -2.45916 Nanomoles per liter (nmol/L) | Standard Deviation 27.497527 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 28 Day 1 | 20.55189 Nanomoles per liter (nmol/L) | Standard Deviation 17.985775 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 8 Day 1 | -0.06812 Nanomoles per liter (nmol/L) | Standard Deviation 24.146111 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 22 Day 1 | 18.57057 Nanomoles per liter (nmol/L) | Standard Deviation 22.383758 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 10 Day 1 | -0.03002 Nanomoles per liter (nmol/L) | Standard Deviation 16.413851 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 32 Day 1 | 16.73184 Nanomoles per liter (nmol/L) | Standard Deviation 23.660023 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 12 Day 1 | -0.82919 Nanomoles per liter (nmol/L) | Standard Deviation 9.539787 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4) | Thyroxine, CFB to Cycle 24 Day 1 | 23.08569 Nanomoles per liter (nmol/L) | Standard Deviation 20.160509 |
Secondary
Change From Baseline in Thyroid Function: Thyrotropin (TSH)
Blood samples were collected for the assessment of Thyroid Function Thyrotropin (TSH).
Time frame: Up to approximately 46 months
Population: Safety population. Only those participants with data available at specified categories have been analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 10 Day 1 | 3.233 Milli-international Units/ Liter | Standard Deviation 12.1571 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 20 Day 1 | 1.685 Milli-international Units/ Liter | Standard Deviation 5.3517 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 6 Day 1 | 1.123 Milli-international Units/ Liter | Standard Deviation 8.4596 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 22 Day 1 | 1.428 Milli-international Units/ Liter | Standard Deviation 5.9512 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 12 Day 1 | 2.448 Milli-international Units/ Liter | Standard Deviation 9.859 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 24 Day 1 | 0.993 Milli-international Units/ Liter | Standard Deviation 3.0372 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 4 Day 1 | 1.285 Milli-international Units/ Liter | Standard Deviation 9.4283 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 26 Day 1 | 1.029 Milli-international Units/ Liter | Standard Deviation 4.308 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 14 Day 1 | 1.282 Milli-international Units/ Liter | Standard Deviation 4.2566 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 28 Day 1 | 1.204 Milli-international Units/ Liter | Standard Deviation 3.4902 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 8 Day 1 | 2.454 Milli-international Units/ Liter | Standard Deviation 9.7235 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 30 Day 1 | 1.615 Milli-international Units/ Liter | Standard Deviation 5.4966 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 16 Day 1 | 1.551 Milli-international Units/ Liter | Standard Deviation 4.7982 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 32 Day 1 | 1.824 Milli-international Units/ Liter | Standard Deviation 4.9423 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 2 Day 1 | 0.225 Milli-international Units/ Liter | Standard Deviation 3.7642 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 34 Day 1 | 1.081 Milli-international Units/ Liter | Standard Deviation 2.4504 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 18 Day 1 | 1.190 Milli-international Units/ Liter | Standard Deviation 4.1837 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to End of Treatment | 2.210 Milli-international Units/ Liter | Standard Deviation 8.3867 |
| Dostarlimab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | Baseline | 1.853 Milli-international Units/ Liter | Standard Deviation 1.8354 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to End of Treatment | 1.303 Milli-international Units/ Liter | Standard Deviation 9.359 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | Baseline | 1.904 Milli-international Units/ Liter | Standard Deviation 1.7421 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 2 Day 1 | -0.497 Milli-international Units/ Liter | Standard Deviation 1.7405 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 4 Day 1 | -0.622 Milli-international Units/ Liter | Standard Deviation 1.7892 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 6 Day 1 | 2.006 Milli-international Units/ Liter | Standard Deviation 21.0213 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 8 Day 1 | 2.648 Milli-international Units/ Liter | Standard Deviation 22.9952 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 10 Day 1 | 1.986 Milli-international Units/ Liter | Standard Deviation 12.8377 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 12 Day 1 | 1.138 Milli-international Units/ Liter | Standard Deviation 10.978 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 14 Day 1 | 1.734 Milli-international Units/ Liter | Standard Deviation 9.0539 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 16 Day 1 | 2.056 Milli-international Units/ Liter | Standard Deviation 13.4532 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 18 Day 1 | -0.406 Milli-international Units/ Liter | Standard Deviation 1.6364 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 20 Day 1 | 1.825 Milli-international Units/ Liter | Standard Deviation 11.8029 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 22 Day 1 | 1.794 Milli-international Units/ Liter | Standard Deviation 10.5658 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 24 Day 1 | 2.161 Milli-international Units/ Liter | Standard Deviation 10.7015 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 26 Day 1 | 2.050 Milli-international Units/ Liter | Standard Deviation 11.8067 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 28 Day 1 | 1.760 Milli-international Units/ Liter | Standard Deviation 9.6622 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 30 Day 1 | 3.468 Milli-international Units/ Liter | Standard Deviation 15.7231 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 32 Day 1 | 0.365 Milli-international Units/ Liter | Standard Deviation 0.8151 |
| Pembrolizumab + Chemotherapy | Change From Baseline in Thyroid Function: Thyrotropin (TSH) | CFB to Cycle 34 Day 1 | -0.189 Milli-international Units/ Liter | Standard Deviation 1.5062 |
Secondary
Mean Change From Baseline in ECG Mean Heart Rate
Participants were in a supine or semi recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs were recorded. Single 12-lead ECG was recorded using an ECG machine. Mean Heart rate were recorded.
Time frame: Baseline (Day 1), Cycle 1 Day 1, and end of treatment (Up to approximately 46 months)
Population: Safety population. Only those participants with data available at specified categories have been analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dostarlimab + Chemotherapy | Mean Change From Baseline in ECG Mean Heart Rate | Baseline | 79.8 beats/min | Standard Deviation 15.17 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in ECG Mean Heart Rate | CFB to Cycle 1 Day 1 | 0.0 beats/min | Standard Deviation 13.04 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in ECG Mean Heart Rate | CFB to End of Treatment | 1.5 beats/min | Standard Deviation 14.71 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in ECG Mean Heart Rate | Baseline | 80.0 beats/min | Standard Deviation 16.14 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in ECG Mean Heart Rate | CFB to Cycle 1 Day 1 | 3.3 beats/min | Standard Deviation 13.65 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in ECG Mean Heart Rate | CFB to End of Treatment | 0.6 beats/min | Standard Deviation 17.95 |
Secondary
Mean Change From Baseline in Electrocardiogram (ECG) Parameters
Participants were in a supine or semi recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs were recorded. Single 12-lead ECG was recorded using an ECG machine. PR, QRS, QT, QTcF, and RR intervals were recorded
Time frame: Baseline (Day 1), Cycle 1 Day 1, and end of treatment (Up to approximately 46 months)
Population: Safety population. Only those participants with data available at specified categories have been analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, Baseline | 157.3 Millisecond (msec) | Standard Deviation 26.87 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, CFB to Cycle 1 Day 1 | -6.0 Millisecond (msec) | Standard Deviation 1.41 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, CFB to End of Treatment | -5.3 Millisecond (msec) | Standard Deviation 23.35 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, Baseline | 87.9 Millisecond (msec) | Standard Deviation 14.85 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, CFB to Cycle 1 Day 1 | 10.0 Millisecond (msec) | Standard Deviation 13.08 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, CFB to End of Treatment | 3.3 Millisecond (msec) | Standard Deviation 17.14 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, Baseline | 370.4 Millisecond (msec) | Standard Deviation 35.29 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, CFB to Cycle 1 Day 1 | -19.5 Millisecond (msec) | Standard Deviation 48.23 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, CFB to End of Treatment | -1.7 Millisecond (msec) | Standard Deviation 36.57 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB Interval, Baseline | 459.3 Millisecond (msec) | Standard Deviation 190.83 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB Interval, CFB to Cycle 1 Day 1 | -309.0 Millisecond (msec) | Standard Deviation 559.52 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB Interval, CFB to End of Treatment | -12.2 Millisecond (msec) | Standard Deviation 176.21 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, Baseline | 406.6 Millisecond (msec) | Standard Deviation 50.6 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, CFB to Cycle 1 Day 1 | -12.3 Millisecond (msec) | Standard Deviation 48.19 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, CFB to End of Treatment | 1.4 Millisecond (msec) | Standard Deviation 65.82 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval, Baseline | 741.3 Millisecond (msec) | Standard Deviation 205.25 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval, CFB to Cycle 1 Day 1 | 81.3 Millisecond (msec) | Standard Deviation 256.2 |
| Dostarlimab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval, CFB to End of Treatment | -3.3 Millisecond (msec) | Standard Deviation 183.71 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, CFB to Cycle 1 Day 1 | -4.7 Millisecond (msec) | Standard Deviation 4.16 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, Baseline | 152.4 Millisecond (msec) | Standard Deviation 25.54 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB Interval, Baseline | 440.4 Millisecond (msec) | Standard Deviation 121.2 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, CFB to Cycle 1 Day 1 | 8.7 Millisecond (msec) | Standard Deviation 16.17 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval, CFB to End of Treatment | 2.5 Millisecond (msec) | Standard Deviation 193.04 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval, CFB to End of Treatment | 0.2 Millisecond (msec) | Standard Deviation 17.49 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB Interval, CFB to Cycle 1 Day 1 | -31.7 Millisecond (msec) | Standard Deviation 49.81 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, Baseline | 89.0 Millisecond (msec) | Standard Deviation 14.91 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, CFB to End of Treatment | -10.0 Millisecond (msec) | Standard Deviation 60 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, CFB to Cycle 1 Day 1 | 6.0 Millisecond (msec) | Standard Deviation 14.14 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB Interval, CFB to End of Treatment | -3.1 Millisecond (msec) | Standard Deviation 30.81 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration, CFB to End of Treatment | -1.1 Millisecond (msec) | Standard Deviation 13.47 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval, CFB to Cycle 1 Day 1 | -10.7 Millisecond (msec) | Standard Deviation 81.05 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, Baseline | 374.3 Millisecond (msec) | Standard Deviation 38.05 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF Interval, Baseline | 412.9 Millisecond (msec) | Standard Deviation 48.99 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, CFB to Cycle 1 Day 1 | -27.3 Millisecond (msec) | Standard Deviation 57.98 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval, Baseline | 766.5 Millisecond (msec) | Standard Deviation 195.43 |
| Pembrolizumab + Chemotherapy | Mean Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval, CFB to End of Treatment | -4.1 Millisecond (msec) | Standard Deviation 38.07 |
Secondary
Number of Participants With Serious AEs
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the above outcomes. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary.
Time frame: Up to approximately 46 months
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Serious AEs | 51 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Serious AEs | 61 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation
AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. Number of participants with TEAEs, TEAEs leading to death, and TEAEs leading to treatment discontinuation are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Time frame: Up to 46 months
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation | TEAEs | 119 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation | TEAEs leading to death | 17 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation | TEAEs leading to treatment discontinuation | 35 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation | TEAEs | 119 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation | TEAEs leading to death | 12 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation | TEAEs leading to treatment discontinuation | 46 Participants |
Secondary
Number of Participants With Treatment Emergent Immune-related Adverse Event (irAE)
The irAEs are events which are severe or fatal and can occur in participants treated with monoclonal antibodies directed against immune checkpoints, including pembrolizumab and dostarlimab. While irAEs (eg, diarrhea/colitis, pneumonitis, nephritis, hypophysitis, adrenalitis, thyroiditis, severe skin reactions, uveitis, myocarditis, and hepatotoxicity) usually occur during treatment, symptoms can also manifest after discontinuation of treatment. AEs were coded using the MedDRA dictionary.
Time frame: Up to 46 months
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Treatment Emergent Immune-related Adverse Event (irAE) | 38 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Treatment Emergent Immune-related Adverse Event (irAE) | 47 Participants |
Secondary
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Normal ranges were 30 to 110 units per liter (U/L) (Amylase); 4. 5 to 5. 6 milligram/deciliters (mg/dL) (Calcium); 96 to 100 milliequivalents (mEq)/ L (Chloride); 2. 5 to 4.5 mg/dL (Phosphate); 6 to 8.3 grams/L (protein); 6 to 24 millimoles/L (Urea) and 7 to 20 mg/dL (Urea nitrogen). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in To Normal or No Change category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Time frame: Up to approximately 46 months
Population: Safety population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Amylase, To Low | 8 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Amylase, To Normal or No Change | 76 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Amylase, To High | 34 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium, To Low | 42 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium, To Normal or No Change | 60 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium, To High | 25 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride, To Low | 34 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride, To Normal or No Change | 65 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride, To High | 22 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Phosphate, To Low | 32 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Phosphate, To Normal or No Change | 64 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Phosphate, To High | 26 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein, To Low | 52 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein, To Normal or No Change | 55 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein, To High | 12 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea, To Low | 7 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea, To Normal or No Change | 43 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea, To High | 41 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea Nitrogen, To Low | 5 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea Nitrogen, To Normal or No Change | 26 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea Nitrogen, To High | 20 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Phosphate, To Normal or No Change | 70 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Amylase, To Low | 11 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea Nitrogen, To Low | 6 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Amylase, To Normal or No Change | 76 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Phosphate, To High | 28 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Amylase, To High | 30 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea, To Normal or No Change | 45 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium, To Low | 39 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein, To Low | 54 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium, To Normal or No Change | 65 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea Nitrogen, To High | 13 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium, To High | 16 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein, To Normal or No Change | 56 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride, To Low | 26 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea, To High | 37 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride, To Normal or No Change | 69 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein, To High | 6 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride, To High | 25 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea Nitrogen, To Normal or No Change | 17 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Phosphate, To Low | 22 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Urea, To Low | 11 Participants |
Secondary
Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured in a semi-supine position after 5 minutes rest. Grades were derived based on numeric criteria as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Systolic Blood Pressure (SBP): Grade 0 (\<120 Millimetre of mercury (mmHg)), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). Diastolic Blood Pressure (DBP): Grade 0 (\<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Only those participants with grade increase have been presented. Participants with missing Baseline values were assumed to have a Baseline value of G0.
Time frame: Up to approximately 46 months
Population: Safety population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 1 | 36 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 2 | 35 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 3 | 6 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 1 | 24 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 2 | 34 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 3 | 8 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 2 | 24 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 1 | 27 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 1 | 18 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 2 | 25 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 3 | 11 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 3 | 7 Participants |
Secondary
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils); 41 to 50 percentage of red blood cells (RBC) in blood (hematocrit); 80-100 femtoliters (fl) (erythrocytes \[referred as Ery\] mean corpuscular volume (EMCV)); 2 to 8 percentage of WBC (monocytes); and Women: 4.2 to 5.4 million RBC/ microliter (mcL) of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in To Normal or No Change category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Time frame: Up to approximately 46 months
Population: Safety population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit, To Normal or No Change | 43 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | EMCV, To High | 57 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils, To Normal or No Change | 72 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes, To Low | 23 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit, To High | 3 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes, To Normal or No Change | 41 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit, To Low | 73 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes, To High | 46 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | EMCV, To Low | 6 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes, To Low | 73 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils, To High | 19 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes, To Normal or No Change | 44 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | EMCV, To Normal or No Change | 59 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes, To High | 2 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils, To Low | 12 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes, To High | 6 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils, To Low | 9 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils, To Normal or No Change | 75 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils, To High | 19 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit, To Low | 64 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit, To Normal or No Change | 50 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit, To High | 1 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | EMCV, To Low | 11 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | EMCV, To Normal or No Change | 54 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | EMCV, To High | 54 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes, To Low | 21 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes, To Normal or No Change | 42 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes, To High | 43 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes, To Low | 79 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes, To Normal or No Change | 34 Participants |
Secondary
Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
Performance status was assessed using the ECOG scale (Grade 0-5). Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead.
Time frame: Up to approximately 46 months
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 1 | 70 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 3 | 4 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 2 | 24 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 4-5 | 5 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 0 | 15 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 4-5 | 4 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 0 | 20 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 1 | 57 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 2 | 20 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | 3 | 14 Participants |
Secondary
Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI)
Normal range of Pulse Rate was 60 to 100 beats/min. Participants were counted in worst case category that their value changes to low, to within \[w/in\] Range or No Change \[NC\] or high, unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in To Normal or No Change category.
Time frame: Up to approximately 46 months
Population: Safety population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI) | To Low | 5 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI) | To w/in Range or No Change | 105 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI) | To High | 7 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI) | To Low | 3 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI) | To w/in Range or No Change | 103 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI) | To High | 9 Participants |
Secondary
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Urine samples were collected to assess urine Bilirubin, glucose, ketones, Leukocyte Esterase, Nitrite, occult blood and Protein using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as No Change/Decreased, Increase to TRACE, Increase to +, Increase to ++, Increase to +++ and Increase to ++++. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Up to approximately 46 months
Population: Safety population. Only those participants with data available at specified categories have been analyzed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to ++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to + | 3 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to +++ | 1 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to ++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to +++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to +++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 79 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to ++++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to ++++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, No Change/Decreased | 77 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to ++++ | 2 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to TRACE | 6 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, No Change/Decreased | 75 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to + | 6 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to + | 8 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to ++ | 3 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to TRACE | 1 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to +++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 81 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to ++++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to + | 11 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 71 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to ++++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 7 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to ++ | 2 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to + | 14 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to TRACE | 4 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to ++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to +++ | 1 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to +++ | 1 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to ++ | 1 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to ++++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to ++++ | 1 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, No Change/Decreased | 86 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to + | 8 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to TRACE | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, No Change/Decreased | 90 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to + | 4 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to TRACE | 2 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to ++ | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to TRACE | 0 Participants |
| Dostarlimab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to +++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, No Change/Decreased | 57 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to ++++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 57 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to TRACE | 1 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to + | 8 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to ++ | 2 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to +++ | 2 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Glucose, Increase to ++++ | 1 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 58 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to TRACE | 3 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to + | 7 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to ++ | 2 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to +++ | 1 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Ketones, Increase to ++++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, No Change/Decreased | 55 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to TRACE | 2 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to + | 10 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to ++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to +++ | 3 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Leukocyte Esterase, Increase to ++++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, No Change/Decreased | 70 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to TRACE | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to + | 1 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to ++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to +++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Nitrite, Increase to ++++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to +++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to TRACE | 3 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to + | 8 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to ++ | 3 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to +++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Occult Blood, Increase to ++++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 53 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 3 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to + | 10 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to ++ | 3 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to +++ | 1 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Protein, Increase to ++++ | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, No Change/Decreased | 66 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to TRACE | 0 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to + | 3 Participants |
| Pembrolizumab + Chemotherapy | Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Bilirubin, Increase to ++ | 0 Participants |
Secondary
Number Participant Who Used Concomitant Medications
Number of participants received concomitant medications were summarized.
Time frame: Up to approximately 46 months
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dostarlimab + Chemotherapy | Number Participant Who Used Concomitant Medications | 121 Participants |
| Pembrolizumab + Chemotherapy | Number Participant Who Used Concomitant Medications | 122 Participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death by any cause.
Time frame: Up to approximately 46 months
Population: Intent-to-treat (ITT) population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dostarlimab + Chemotherapy | Overall Survival (OS) | 20.2 Months |
| Pembrolizumab + Chemotherapy | Overall Survival (OS) | 15.9 Months |
Secondary
Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of disease progression (PD) or death by any cause, whichever occurs first. PFS was evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 based on Investigator assessment. PD 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).
Time frame: Up to approximately 46 months
Population: Intent-to-treat (ITT) population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dostarlimab + Chemotherapy | Progression-free Survival (PFS) | 8.8 Months |
| Pembrolizumab + Chemotherapy | Progression-free Survival (PFS) | 6.8 Months |