Neoplasms
Conditions
Keywords
advanced solid tumor, Head and Neck Squamous Cell Carcinoma, standard of care, GSK3359609, urothelial carcinoma of the upper and lower urinary tract, non-small cell lung cancer, cutaneous melanoma, Tremelimumab, clear cell renal carcinoma, castrate resistant prostate adenocarcinoma
Brief summary
The purpose of this study is to evaluate if the combination of GSK3359609 and tremelimumab is safe and tolerable (Part 1) and provides significant survival benefit to subjects with relapsed/refractory (R/R) Head and Neck Squamous Cell Carcinomas (HNSCC) to warrant further clinical investigation (Part 2). Part 1 (dose escalation) will enroll subjects with advanced, selected solid tumors. Subjects will receive escalating doses of GSK3359609 and tremelimumab in combination in Part 1. Part 2 is randomized expansion and will enroll subjects with R/R HNSCC who have disease progression after receiving at least 1 platinum-based chemotherapy and at least 1 anti-programmed death receptor protein-1 (PD-1)/anti-programmed death-ligand 1 (PD-L1) therapy, whether in combination or separately. In Part 2, subjects will be randomized in a ratio of 2:1 to receive either GSK3359609 in combination with tremelimumab at the recommended Phase 2 dose or investigators choice of a single-agent standard of care (SOC) therapy including paclitaxel, docetaxel or cetuximab. The total duration of subjects in the study will be approximately 4 years.
Interventions
DRUGfeladilimab
feladilimab is humanized anti-ICOS agonist immunoglobulin G (IgG) 4 monoclonal antibody (mAb), which will be administered as an intravenous (IV) infusion once every 3 weeks.
DRUGTremelimumab
Tremelimumab is humanized anti-CTLA-4 IgG2 mAb, which will be administered as an IV infusion once every 3 weeks for 6 doses, thereafter once every 12 weeks .
DRUGDocetaxel
Docetaxel is a microtubule stabilizer which will be administered as an IV infusion once every 3 weeks at a dose of 75 milligrams per meter square (mg/m\^2).
DRUGPaclitaxel
Paclitaxel is a microtubule stabilizer which will be administered as an IV infusion once weekly at a dose of 80 mg/m\^2.
DRUGCetuximab
Cetuximab is a recombinant, human/mouse chimeric anti-estimated glomerular filtration rate (EGFR) mAb. Cetuximab will be administered at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly.
Sponsors
MedImmune LLC
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In Part 1, dose escalation will occur using a zone based approach. Part 2 will be randomized, parallel group study wherein the subjects will be randomized in a ratio of 2:1 to either recommended Phase 2 dose combination of GSK3359609 and tremelimumab or SOC (paclitaxel, docetaxel or cetuximab).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol. * Male or female, aged 18 years or older. * Body weight \>=30 kilograms (kg). * Histological or cytological documentation of an invasive malignancy that was diagnosed as locally advanced/metastatic or relapsed/refractory and is of one of the following tumor types: a) Part 1: cutaneous melanoma; HNSCC (oral cavity, larynx, oropharynx, hypopharynx, nasal cavity/paranasal sinuses); non-small cell lung cancer (squamous and non-squamous); urothelial carcinoma of the upper and lower urinary tract; clear cell renal carcinoma; castrate resistant prostate adenocarcinoma. b) Part 2: HNSCC (oral cavity, larynx, pharynx, paranasal sinuses). * Part 1 only: Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists, or where standard therapy is refused. May be anti-PD-1/anti-PD-L1 experienced or naïve. * Part 2 only: Disease that has progressed after receiving platinum-based chemotherapy (unless medically contraindicated or discontinued due to toxicity) and anti-PD-1/anti-PD-L1 therapy (in combination or as separate lines of therapy in either sequence). * Measurable disease per RECIST version 1.1 guidelines. Palpable lesions that are not measurable by radiographic or photographic evaluations may not be utilized as the only measurable lesion. Any measurable lesion biopsied at Screening cannot be followed as a target/index lesion unless agreed upon by GlaxoSmithKline (GSK). * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1. * Adequate organ function. * A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions apply: a) Not a woman of childbearing potential (WOCBP); or, b) A WOCBP who agrees to follow the contraceptive while receiving study intervention and for at least 180 days after the last dose of study intervention. * A male subject must agree to use a highly effective contraception while receiving study intervention and for at least 180 days after the last dose of study intervention and refrain from donating sperm during this period. * Agree to collection of tumor tissue: a) Part 1 and Part 2: Archival tumor tissue collected any time from the initial diagnosis of invasive malignancy; a fresh tumor biopsy will be required if archival specimen is unavailable prior to first dose. b) Part 1 pharmacokinetic/pharmacodynamic cohort(s): Archival tissue as noted in point (a) above. Paired tumor biopsies: tumor tissue collected any time after completion of dosing of the last therapy and prior to first dose and an on-treatment biopsy. c) Part 2: A minimum of 15 subjects from each arm will be required to provide paired tumor biopsies (in addition to the archival tissues as noted in point (a) above): tumor tissue collected any time after completion of dosing of the last therapy and prior to first dose and an on-treatment biopsy.
Exclusion criteria
* Received prior treatment with the following therapies; calculation is based on date of last therapy to date of first dose of study intervention or SOC: a) Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4 \[including tremelimumab\] or Inducible T Cell Co-Stimulator (ICOS)-directed therapies at any time; b) \>=4 lines of prior anticancer treatment: In subjects that relapse or progress within 1 year from the beginning of adjuvant or concurrent therapy, the adjuvant/concurrent therapy is considered first line therapy; c) Systemic anticancer therapy or investigational therapy within 30 days, or 5 half-lives, whichever is shorter; at least 14 days must have elapsed between the date of the last prior therapy to the date of first dose of study intervention or SOC. * Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST v1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. At least 14 days must have elapsed between the date of the last dosage of radiation and the first dose of study intervention/SOC. * Invasive malignancy or history of invasive malignancy other than disease under study within the last two years, except: a) Any other invasive malignancy for which the subject was definitively treated, has been disease-free for \<=2 years and in the opinion of the Investigator and Medical Monitor will not affect the evaluation of the effects of the study intervention or SOC on the currently targeted malignancy, may be included in this clinical study; Curatively treated non-melanoma skin cancer or successfully treated in-situ carcinoma. * Toxicity from previous anticancer treatment that includes: a) \>=Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation; b) Toxicity related to prior treatment that has not resolved to \<=Grade 1 (except alopecia, vitiligo, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be \<=Grade 2). * Central nervous system (CNS) metastases, with the following exception: Subjects with previously treated CNS metastases who are clinically stable and had no requirement for steroids during at least 14 days prior to first dose of study intervention or SOC. * Major surgery \<=28 days of first dose of study intervention or SOC. * Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (i.e., adrenal insufficiency) are not considered systemic treatments. * Recent history (within 24 weeks) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess. * Receiving systemic steroids (\>=10 milligrams \[mg\] oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study intervention or SOC. * Prior allogeneic/autologous bone marrow or solid organ transplantation. * Received live-virus vaccine within 30 days from start of study intervention or SOC. * Current or history of idiopathic pulmonary fibrosis, pneumonitis (for past, subject is excluded if steroids were required), interstitial lung disease or organizing pneumonia. * Recent history (within 24 weeks) of uncontrolled, symptomatic ascites, pleural or pericardial effusions. * History or evidence of cardiac abnormalities within the 24 weeks prior to enrollment which include: a) Serious uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block. b) Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting. c) Symptomatic pericarditis. * Current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Active infection requiring systemic therapy. * Known human immunodeficiency virus infection; positive test for hepatitis B active infection (presence of hepatitis B surface antigen) or hepatitis C active infection. * History of severe hypersensitivity to monoclonal antibodies, the Standard of Care agents, including any ingredient used in the formulation, based on which treatment the subject is to receive. * Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator. * For subjects receiving SOC: Requires therapy with a medication that may alter the PK of the SOC agent (e.g., strong inducers or inhibitors of cytochrome P (CYP)3A4 for subjects receiving docetaxel or paclitaxel) during the study treatment period. Please refer to the package insert for the agent the subject is to receive. * For subjects receiving SOC: Any contraindication, per the package insert and/or Institutional guidelines, to the treatment the subject is to receive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Specific Gravity of Urine-Part 1 | Baseline (Day 1) and Week 4 | Urine samples were collected to assess change from baseline in specific gravity of urine. |
| Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1 | Up to 28 days | A DLT is considered by the investigator to be clinically relevant, attributed event within first 28 days of intervention meeting the following criteria of toxicity, Hematologic: Febrile neutropenia, Grade 4 neutropenia of greater than (\>) 7 days in duration or requiring Granulocyte- Colony stimulating factor (G-CSF), Grade 4 anemia and Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; Non-hematologic: Grade 4 toxicity, Grade 3 pneumonitis, any greater than or equal to (≥) Grade 2 pneumonitis that does not resolve to less than or equal to (≤ ) Grade 1 within 3 days of the initiation of maximal supportive care, Grade 3 toxicity that does not resolve to Grade 1 or baseline within 3 days despite optimal supportive care and any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity. |
| Number of Participants With DLTs According to Severity-Part 1 | Up to 28 days | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | Up to 4 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs. |
| Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Up to 4 years | The number of participants with AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized. |
| Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Up to 4 years | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE. |
| Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Up to 4 years | The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | Baseline (Day 1) and Week 4 | SBP and DBP were measured after 5 minutes of rest for the participant. |
| Change From Baseline in Temperature-Part 1 | Baseline (Day 1) and Week 4 | Temperature was measured after 5 minutes of rest for the participant. |
| Change From Baseline in Pulse Rate-Part 1 | Baseline (Day 1) and Week 4 | Pulse rate was measured after 5 minutes of rest for the participant. |
| Change From Baseline in Respiratory Rate-Part 1 | Baseline (Day 1) and Week 4 | Respiratory rate was measured after 5 minutes of rest for the participant. |
| Change From Baseline in Oxygen Saturation-Part 1 | Baseline (Day 1) and Week 4 | Oxygen saturation was measured using pulse oximeter after 5 minutes of rest for the participant. |
| Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) and up to 4 Years | Single 12-lead ECG was obtained using an automated ECG machine. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator. |
| Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet counts. |
| Change From Baseline in Hemoglobin Level-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from baseline in hemoglobin level. |
| Change From Baseline in Hematocrit Level-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from baseline in hematocrit level. |
| Change From Baseline in Erythrocytes Count-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from baseline in Erythrocytes count. |
| Change From Baseline in Albumin and Total Protein Levels-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from Baseline in albumin and total protein levels. |
| Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from baseline in creatinine and bilirubin levels. |
| Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from baseline in ALT, AST ALP, LDH levels. |
| Change From Baseline in Amylase and Lipase Levels-Part 1 | Baseline (Day 1) and week 4 | Blood samples were collected to assess change from baseline in amylase and lipase levels. |
| Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline. |
| Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Baseline (Day 1) and Week 4 | Urine samples were collected to assess change from baseline in pH of urine. |
| Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Week 4 | The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose in urine. Positive test results were considered as abnormal. Number of participants with positive test results have been summarized. |
| Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from Baseline in TSH. |
| Change From Baseline in Free Triiodothyronine (T3)-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from Baseline in free T3. |
| Change From Baseline in Free Thyroxine (T4)-Part 1 | Baseline (Day 1) and Week 4 | Blood samples were collected to assess change from baseline in free T4. |
| Overall Survival-Part 2 | Up to 4 years | For participants in Part 2, overall survival is defined as time from the date of randomization to the date of death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Temperature-Part 2 | Baseline and up to 2 years | Temperature will be measured after 5 minutes of rest for the participant. |
| Change From Baseline in Pulse Rate-Part 2 | Baseline and up to 2 years | Pulse rate will be measured after 5 minutes of rest for the participant. |
| Change From Baseline in Respiratory Rate-Part 2 | Baseline and up to 2 years | Respiratory rate will be measured after 5 minutes of rest for the participant. |
| Change From Baseline in Oxygen Saturation-Part 2 | Baseline and up to 2 years | Oxygen saturation will be measured using pulse oximetry after 5 minutes of rest for the participant. |
| Change From Baseline in ECG Measurement-Part 2 | Baseline (Pre-dose) up to 2 years | Single 12-lead ECG will be obtained using an automated ECG machine. |
| Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count. |
| Change From Baseline in Hemoglobin Level-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from baseline in hemoglobin level. |
| Change From Baseline in Hematocrit Level-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from baseline in hematocrit level. |
| Change From Baseline in Erythrocytes Count-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from Baseline in erythrocytes count. |
| Change From Baseline in Albumin and Total Protein Levels-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from baseline in albumin and total protein levels. |
| Change From Baseline in Creatinine and Bilirubin Levels-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from baseline in creatinine and bilirubin levels. |
| Change From Baseline in ALT, AST, ALP, LDH Levels-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from baseline in ALT, AST ALP, LDH, amylase and lipase levels. |
| Change From Baseline in Amylase and Lipase Levels-Part 2 | Baseline and up to 2 years | Blood samples were collected to assess change from baseline in amylase and lipase levels. |
| Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels -Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline. |
| Change From Baseline in Specific Gravity of Urine-Part 2 | Baseline and up to 2 years | Urine samples will be collected to assess change from Baseline in specific gravity of urine. |
| Change From Baseline in pH of Urine-Part 2 | Baseline and up to 2 years | Urine samples will be collected to assess change from baseline in pH of urine. |
| Number of Participants With Abnormal Urinalysis Parameters-Part 2 | Up to 2 years | The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose. Positive test results were considered as abnormal. Number of participants with positive test results were planned to be summarized. |
| Change From Baseline in TSH-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from Baseline in TSH. |
| Overall Response Rate-Part 1 | Up to 4 years | Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 millimeter \[mm\]) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per response evaluation criteria in solid tumors (RECIST) version 1.1. |
| Change From Baseline in Free T3-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from baseline in free T3. |
| Overall Response Rate-Part 2 | Up to 4 years | Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per RECIST version 1.1. |
| Disease Control Rate-Part 1 | Up to 4 years | Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1. |
| Disease Control Rate-Part 2 | Up to 4 years | Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1. |
| Progression Free Survival-Part 2 | Up to 4 years | For Part 2, progression free survival duration is defined as the time from the date of randomization to first documented evidence of disease progression (At least a 20% increase in the sum of diameters of target lesions and In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm) or death (regardless of cause of death), whichever comes first as per RECIST version 1.1. |
| Time to Response-Part 2 | Up to 4 years | Time to response is defined as the time from the first dose to the first documented evidence of complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) for participants with a confirmed CR or PR as per RECIST version 1.1. |
| Duration of Response-Part 2 | Up to 4 years | Duration of response is defined as time from the first documented evidence of response until the first documented sign of disease progression or death among participants who achieve a response (CR \[Disappearance of all target lesions. Any pathological lymph nodes {whether target or non-target} must have reduction in short axis to \<10 mm or PR \[At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters\] as per RECIST version 1.1). |
| Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1 | Pre-dose, end of infusion and 4 hours post dose at Day 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. |
| Cmax of Tremelimumab-Part 1 | Pre-dose, end of infusion and 4 hours post dose at Day 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. |
| Cmax of Feladilimab-Part 2 | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. |
| Cmax of Tremelimumab-Part 2 | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. |
| Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1 | Pre-dose, end of infusion and 4 hours post dose at Day 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. |
| Cmin of Tremelimumab-Part 1 | Pre-dose, end of infusion and 4 hours post dose at Day 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. |
| Cmin of Feladilimab-Part 2 | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. |
| Cmin of Tremelimumab-Part 2 | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. |
| Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1 | Pre-dose, end of infusion and 4 hours post dose at Day 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. |
| AUC(0-t) of Tremelimumab-Part 1 | Pre-dose, end of infusion and 4 hours post dose at Day 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. |
| AUC(0-t) of Feladilimab-Part 2 | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25, and 4 hours post-infusion at Week 1 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. |
| AUC(0-t) of Tremelimumab-Part 2 | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment |
| Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Pre-dose at Week 4, 7, 10 and 13 | Serum samples were collected and tested for the presence of antibodies to feladilimab. |
| Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Pre-dose at Week 1, 4, 7, 10 and 13 | Serum samples were collected and tested for the presence of antibodies to tremelimumab. |
| Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 2 | Up to 2.5 years | Serum samples will be collected and tested for the presence of antibodies to feladilimab. |
| Change From Baseline in Free T4-Part 2 | Baseline and up to 2 years | Blood samples will be collected to assess change from baseline in free T4. |
| Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 2 | Up to 2.5 years | Serum samples will be collected and tested for the presence of antibodies to tremelimumab. |
| Number of Participants With AEs, SAEs and AESI-Part 2 | Up to 4 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs. |
| Number of Participants With AEs, SAEs, AESIs Based on Severity-Part 2 | Up to 4 years | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE |
| Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 2 | Up to 4 years | The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were planned to be summarized. |
| Change From Baseline in SBP and DBP-Part 2 | Baseline and up to 2 years | SBP and DBP will be measured after 5 minutes of rest for the participant. |
Countries
Australia, Canada, United States
Participant flow
Recruitment details
The study was conducted in United States and Canada.
Pre-assignment details
The results presented are for Part 1 of the study. Part 2 was not initiated due to Sponsor decision to not proceed based on scientific and portfolio priority reasons and lack of adequate efficacy and not due to safety reasons in Part 1. A total of 26 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 1 |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 1 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 5 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 3 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 16 |
| Part 2: Feladilimab + Tremelimumab In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination. | 0 |
| Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice. | 0 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 0 | 1 | 0 | 0 | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Total | Part 2: Standard of Care (SOC) | Part 2: Feladilimab + Tremelimumab |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 51.0 YEARS STANDARD_DEVIATION 0 | 51.0 YEARS STANDARD_DEVIATION 0 | 58.2 YEARS STANDARD_DEVIATION 11.73 | 69.0 YEARS STANDARD_DEVIATION 12.77 | 66.8 YEARS STANDARD_DEVIATION 11.51 | 64.2 YEARS STANDARD_DEVIATION 11.95 | — | — |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 1 Participants | 1 Participants | 5 Participants | 3 Participants | 14 Participants | 24 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 4 Participants | 9 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 12 Participants | 17 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 5 | 0 / 3 | 1 / 16 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 5 / 5 | 3 / 3 | 16 / 16 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 3 / 5 | 3 / 3 | 6 / 16 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1
Blood samples were collected to assess change from baseline in ALT, AST ALP, LDH levels.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Baseline (Day 1) | 53 International Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Week 4 | 2 International Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Baseline (Day 1) | 18 International Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Week 4 | -2 International Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Baseline (Day 1) | 32 International Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Week 4 | 0 International Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Baseline (Day 1) | 325 International Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Week 4 | 127 International Units/milliliter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Baseline (Day 1) | 44 International Units/milliliter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Baseline (Day 1) | 25 International Units/milliliter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Baseline (Day 1) | 382 International Units/milliliter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Baseline (Day 1) | 68 International Units/milliliter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Week 4 | 10 International Units/milliliter | Standard Deviation 14.2 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Baseline (Day 1) | 307.4 International Units/milliliter | Standard Deviation 416.93 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Baseline (Day 1) | 24 International Units/milliliter | Standard Deviation 14.18 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Week 4 | 8.2 International Units/milliliter | Standard Deviation 13.05 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Baseline (Day 1) | 24.6 International Units/milliliter | Standard Deviation 9.91 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Baseline (Day 1) | 228.8 International Units/milliliter | Standard Deviation 20.69 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Week 4 | 55.8 International Units/milliliter | Standard Deviation 101.74 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Week 4 | 11.4 International Units/milliliter | Standard Deviation 42.76 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Week 4 | 31.3 International Units/milliliter | Standard Deviation 53.3 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Baseline (Day 1) | 121.5 International Units/milliliter | Standard Deviation 82.73 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Week 4 | -18 International Units/milliliter | Standard Deviation 25.46 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Week 4 | -4.7 International Units/milliliter | Standard Deviation 15.14 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Baseline (Day 1) | 26.7 International Units/milliliter | Standard Deviation 24.79 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Baseline (Day 1) | 23.7 International Units/milliliter | Standard Deviation 15.89 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Baseline (Day 1) | 168 International Units/milliliter | Standard Deviation 104.23 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Week 4 | -7 International Units/milliliter | Standard Deviation 14.73 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Baseline (Day 1) | 21.9 International Units/milliliter | Standard Deviation 8.23 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Baseline (Day 1) | 18.2 International Units/milliliter | Standard Deviation 13.49 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Baseline (Day 1) | 239.9 International Units/milliliter | Standard Deviation 139.36 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALT, Week 4 | 7.4 International Units/milliliter | Standard Deviation 26.46 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | LDH, Week 4 | 42.9 International Units/milliliter | Standard Deviation 85.66 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Week 4 | 36.2 International Units/milliliter | Standard Deviation 75.58 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | AST, Week 4 | 12.9 International Units/milliliter | Standard Deviation 35.1 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | ALP, Baseline (Day 1) | 120.2 International Units/milliliter | Standard Deviation 60.54 |
Primary
Change From Baseline in Albumin and Total Protein Levels-Part 1
Blood samples were collected to assess change from Baseline in albumin and total protein levels.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Baseline (Day 1) | 41 grams/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Week 4 | 0 grams/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Protein, Baseline (Day 1) | 71 grams/Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Baseline (Day 1) | 40 grams/Liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Baseline (Day 1) | 36 grams/Liter | Standard Deviation 7.18 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Protein, Week 4 | 3.3 grams/Liter | Standard Deviation 2.89 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Protein, Baseline (Day 1) | 66.7 grams/Liter | Standard Deviation 7.02 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Week 4 | 0 grams/Liter | Standard Deviation 3.81 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Protein, Week 4 | 0 grams/Liter | Standard Deviation 4.36 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Baseline (Day 1) | 36.7 grams/Liter | Standard Deviation 9.24 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Week 4 | -0.7 grams/Liter | Standard Deviation 2.31 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Protein, Baseline (Day 1) | 73 grams/Liter | Standard Deviation 3.61 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Protein, Week 4 | 1.4 grams/Liter | Standard Deviation 4.31 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Protein, Baseline (Day 1) | 72.1 grams/Liter | Standard Deviation 6.51 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Baseline (Day 1) | 37.9 grams/Liter | Standard Deviation 2.79 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Albumin, Week 4 | -2.1 grams/Liter | Standard Deviation 2.81 |
Primary
Change From Baseline in Amylase and Lipase Levels-Part 1
Blood samples were collected to assess change from baseline in amylase and lipase levels.
Time frame: Baseline (Day 1) and week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Baseline (Day 1) | 48 Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Week 4 | -2 Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Baseline (Day 1) | 28 Units/milliliter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Week 4 | 0 Units/milliliter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Baseline (Day 1) | 23 Units/milliliter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Baseline (Day 1) | 50 Units/milliliter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Baseline (Day 1) | 50.8 Units/milliliter | Standard Deviation 55.65 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Week 4 | 1.5 Units/milliliter | Standard Deviation 4.65 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Baseline (Day 1) | 50.2 Units/milliliter | Standard Deviation 34.85 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Week 4 | -5.3 Units/milliliter | Standard Deviation 7.23 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Baseline (Day 1) | 40 Units/milliliter | Standard Deviation 15.62 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Week 4 | -5 Units/milliliter | Standard Deviation 1 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Week 4 | -13 Units/milliliter | Standard Deviation 23.81 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Baseline (Day 1) | 54.7 Units/milliliter | Standard Deviation 48.99 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Week 4 | 6.1 Units/milliliter | Standard Deviation 35.96 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Lipase, Baseline (Day 1) | 34.6 Units/milliliter | Standard Deviation 27.8 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Week 4 | -3.5 Units/milliliter | Standard Deviation 9.64 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Amylase and Lipase Levels-Part 1 | Amylase, Baseline (Day 1) | 51.5 Units/milliliter | Standard Deviation 26.72 |
Primary
Change From Baseline in Creatinine and Bilirubin Levels-Part 1
Blood samples were collected to assess change from baseline in creatinine and bilirubin levels.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Baseline (Day 1) | 5 micromoles/ Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Week 4 | -1 micromoles/ Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Baseline (Day 1) | 59000 micromoles/ Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Week 4 | 1000 micromoles/ Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Baseline (Day 1) | 63000 micromoles/ Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Baseline (Day 1) | 7 micromoles/ Liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Baseline (Day 1) | 31636.7 micromoles/ Liter | Standard Deviation 43702.44 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Week 4 | -1798.9 micromoles/ Liter | Standard Deviation 3493.56 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Baseline (Day 1) | 6.1 micromoles/ Liter | Standard Deviation 2.44 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Week 4 | 2.2 micromoles/ Liter | Standard Deviation 2.48 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Baseline (Day 1) | 6.1 micromoles/ Liter | Standard Deviation 2.84 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Week 4 | -1.1 micromoles/ Liter | Standard Deviation 1.97 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Week 4 | 3.1 micromoles/ Liter | Standard Deviation 4.29 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Baseline (Day 1) | 73.5 micromoles/ Liter | Standard Deviation 33.52 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Week 4 | -2.9 micromoles/ Liter | Standard Deviation 9.53 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Creatinine, Baseline (Day 1) | 93 micromoles/ Liter | Standard Deviation 44.72 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Week 4 | -0.4 micromoles/ Liter | Standard Deviation 1.52 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Bilirubin, Baseline (Day 1) | 6.5 micromoles/ Liter | Standard Deviation 4.23 |
Primary
Change From Baseline in Erythrocytes Count-Part 1
Blood samples were collected to assess change from baseline in Erythrocytes count.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Erythrocytes Count-Part 1 | Week 4 | 0.13 10^12 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Erythrocytes Count-Part 1 | Baseline (Day 1) | 4.2 10^12 cells/liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Erythrocytes Count-Part 1 | Baseline (Day 1) | 4.65 10^12 cells/liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Erythrocytes Count-Part 1 | Week 4 | -0.216 10^12 cells/liter | Standard Deviation 0.2131 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Erythrocytes Count-Part 1 | Baseline (Day 1) | 4.328 10^12 cells/liter | Standard Deviation 1.2592 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Erythrocytes Count-Part 1 | Baseline (Day 1) | 4.673 10^12 cells/liter | Standard Deviation 0.4885 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Erythrocytes Count-Part 1 | Week 4 | 0.04 10^12 cells/liter | Standard Deviation 0.1652 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Erythrocytes Count-Part 1 | Week 4 | 0.016 10^12 cells/liter | Standard Deviation 0.3913 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Erythrocytes Count-Part 1 | Baseline (Day 1) | 3.76 10^12 cells/liter | Standard Deviation 0.526 |
Primary
Change From Baseline in Free Thyroxine (T4)-Part 1
Blood samples were collected to assess change from baseline in free T4.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Free Thyroxine (T4)-Part 1 | Baseline (Day 1) | 10 Picomoles per liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Free Thyroxine (T4)-Part 1 | Baseline (Day 1) | 11 Picomoles per liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Free Thyroxine (T4)-Part 1 | Baseline (Day 1) | 12.43 Picomoles per liter | Standard Deviation 3.128 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Free Thyroxine (T4)-Part 1 | Week 4 | 2.57 Picomoles per liter | — |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Free Thyroxine (T4)-Part 1 | Baseline (Day 1) | 13.84 Picomoles per liter | Standard Deviation 2.296 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Free Thyroxine (T4)-Part 1 | Baseline (Day 1) | 15.98 Picomoles per liter | Standard Deviation 3.144 |
Primary
Change From Baseline in Free Triiodothyronine (T3)-Part 1
Blood samples were collected to assess change from Baseline in free T3.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Free Triiodothyronine (T3)-Part 1 | Baseline (Day 1) | 3.5 Picomoles per liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Free Triiodothyronine (T3)-Part 1 | Baseline (Day 1) | 3.6 Picomoles per liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Free Triiodothyronine (T3)-Part 1 | Baseline (Day 1) | 2.75 Picomoles per liter | Standard Deviation 0.212 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Free Triiodothyronine (T3)-Part 1 | Baseline (Day 1) | 4.47 Picomoles per liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Free Triiodothyronine (T3)-Part 1 | Baseline (Day 1) | 3.88 Picomoles per liter | Standard Deviation 0.665 |
Primary
Change From Baseline in Hematocrit Level-Part 1
Blood samples were collected to assess change from baseline in hematocrit level.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Hematocrit Level-Part 1 | Week 4 | 0 fraction of 1 | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Hematocrit Level-Part 1 | Baseline (Day 1) | 0.38 fraction of 1 | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Hematocrit Level-Part 1 | Baseline (Day 1) | 0.4 fraction of 1 | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Hematocrit Level-Part 1 | Week 4 | -0.0202 fraction of 1 | Standard Deviation 0.01494 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Hematocrit Level-Part 1 | Baseline (Day 1) | 0.385 fraction of 1 | Standard Deviation 0.10999 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Hematocrit Level-Part 1 | Baseline (Day 1) | 0.3937 fraction of 1 | Standard Deviation 0.0647 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Hematocrit Level-Part 1 | Week 4 | -0.0017 fraction of 1 | Standard Deviation 0.01102 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Hematocrit Level-Part 1 | Week 4 | -0.0039 fraction of 1 | Standard Deviation 0.03413 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Hematocrit Level-Part 1 | Baseline (Day 1) | 0.3421 fraction of 1 | Standard Deviation 0.03603 |
Primary
Change From Baseline in Hemoglobin Level-Part 1
Blood samples were collected to assess change from baseline in hemoglobin level.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Hemoglobin Level-Part 1 | Week 4 | 5 grams/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Hemoglobin Level-Part 1 | Baseline (Day 1) | 125 grams/liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Hemoglobin Level-Part 1 | Baseline (Day 1) | 134 grams/liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Hemoglobin Level-Part 1 | Week 4 | -5.8 grams/liter | Standard Deviation 4.21 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Hemoglobin Level-Part 1 | Baseline (Day 1) | 123.4 grams/liter | Standard Deviation 32.61 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Hemoglobin Level-Part 1 | Week 4 | 0.3 grams/liter | Standard Deviation 2.89 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Hemoglobin Level-Part 1 | Baseline (Day 1) | 125 grams/liter | Standard Deviation 23.07 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Hemoglobin Level-Part 1 | Baseline (Day 1) | 111.5 grams/liter | Standard Deviation 12.74 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Hemoglobin Level-Part 1 | Week 4 | -0.7 grams/liter | Standard Deviation 10.78 |
Primary
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1
Blood samples were collected to assess change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet counts.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Week 4 | 0 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Week 4 | -1 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Week 4 | 0.3 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Week 4 | 0.4 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Baseline (Day 1) | 0.00 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Baseline (Day 1) | 4 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Baseline (Day 1) | 1 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Week 4 | 0.00 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Baseline (Day 1) | 0.4 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Week 4 | 0.4 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Baseline (Day 1) | 196 10^9 cells/liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Baseline (Day 1) | 0.3 10^9 cells/liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Baseline (Day 1) | 1.5 10^9 cells/liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Baseline (Day 1) | 325 10^9 cells/liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Baseline (Day 1) | 0.3 10^9 cells/liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Baseline (Day 1) | 0.1 10^9 cells/liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Baseline (Day 1) | 3.9 10^9 cells/liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Baseline (Day 1) | 0.00 10^9 cells/liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Baseline (Day 1) | 250.6 10^9 cells/liter | Standard Deviation 103.5 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Baseline (Day 1) | 0.05 10^9 cells/liter | Standard Deviation 0.0577 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Week 4 | 0 10^9 cells/liter | Standard Deviation 0 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Baseline (Day 1) | 0.35 10^9 cells/liter | Standard Deviation 0.173 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Week 4 | 0.03 10^9 cells/liter | Standard Deviation 0.15 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Baseline (Day 1) | 0.9 10^9 cells/liter | Standard Deviation 0.216 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Week 4 | 0.23 10^9 cells/liter | Standard Deviation 0.15 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Baseline (Day 1) | 0.8 10^9 cells/liter | Standard Deviation 0.2944 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Week 4 | 0.05 10^9 cells/liter | Standard Deviation 0.1732 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Baseline (Day 1) | 4.38 10^9 cells/liter | Standard Deviation 1.548 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Week 4 | 0.93 10^9 cells/liter | Standard Deviation 0.512 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Week 4 | 8.6 10^9 cells/liter | Standard Deviation 34.93 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Baseline (Day 1) | 1.255 10^9 cells/liter | Standard Deviation 0.9122 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Baseline (Day 1) | 0.01 10^9 cells/liter | Standard Deviation 0.0141 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Week 4 | -0.215 10^9 cells/liter | Standard Deviation 0.1202 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Week 4 | 0.06 10^9 cells/liter | Standard Deviation 0.064 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Baseline (Day 1) | 6.2 10^9 cells/liter | Standard Deviation 2.97 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Baseline (Day 1) | 0.08 10^9 cells/liter | Standard Deviation 0.113 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Week 4 | -8.7 10^9 cells/liter | Standard Deviation 16.65 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Week 4 | -0.9 10^9 cells/liter | Standard Deviation 0.7 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Week 4 | 0.005 10^9 cells/liter | Standard Deviation 0.0071 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Baseline (Day 1) | 229.7 10^9 cells/liter | Standard Deviation 147.06 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Week 4 | -0.38 10^9 cells/liter | Standard Deviation 0.46 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Baseline (Day 1) | 1.25 10^9 cells/liter | Standard Deviation 0.212 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Baseline (Day 1) | 0.92 10^9 cells/liter | Standard Deviation 0.223 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Baseline (Day 1) | 0.738 10^9 cells/liter | Standard Deviation 0.3004 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Week 4 | 0.07 10^9 cells/liter | Standard Deviation 0.169 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Baseline (Day 1) | 266.3 10^9 cells/liter | Standard Deviation 90.28 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Week 4 | -8.95 10^9 cells/liter | Standard Deviation 26.151 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Monocytes, Week 4 | 0.038 10^9 cells/liter | Standard Deviation 0.2598 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Week 4 | 0.007 10^9 cells/liter | Standard Deviation 0.0344 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Eosinophils, Baseline (Day 1) | 0.2 10^9 cells/liter | Standard Deviation 0.217 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Platelets, Week 4 | 31.3 10^9 cells/liter | Standard Deviation 42.72 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Lymphocytes, Week 4 | 0.01 10^9 cells/liter | Standard Deviation 0.185 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Neutrophils, Baseline (Day 1) | 11.32 10^9 cells/liter | Standard Deviation 21.379 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Basophils, Baseline (Day 1) | 0.039 10^9 cells/liter | Standard Deviation 0.048 |
Primary
Change From Baseline in Oxygen Saturation-Part 1
Oxygen saturation was measured using pulse oximeter after 5 minutes of rest for the participant.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Oxygen Saturation-Part 1 | Baseline (Day 1) | 96 Percentage (%) of Oxygen | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Oxygen Saturation-Part 1 | Week 4 | 2 Percentage (%) of Oxygen | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Oxygen Saturation-Part 1 | Baseline (Day 1) | 95 Percentage (%) of Oxygen | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Oxygen Saturation-Part 1 | Week 4 | 5 Percentage (%) of Oxygen | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Oxygen Saturation-Part 1 | Baseline (Day 1) | 95.6 Percentage (%) of Oxygen | Standard Deviation 2.881 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Oxygen Saturation-Part 1 | Week 4 | 0.8 Percentage (%) of Oxygen | Standard Deviation 1.304 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Oxygen Saturation-Part 1 | Week 4 | 0 Percentage (%) of Oxygen | Standard Deviation 2 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Oxygen Saturation-Part 1 | Baseline (Day 1) | 96 Percentage (%) of Oxygen | Standard Deviation 1 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Oxygen Saturation-Part 1 | Baseline (Day 1) | 97.63 Percentage (%) of Oxygen | Standard Deviation 1.586 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Oxygen Saturation-Part 1 | Week 4 | -0.2 Percentage (%) of Oxygen | Standard Deviation 2.007 |
Primary
Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1
Urine samples were collected to assess change from baseline in pH of urine.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Week 4 | -0.5 pH | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Baseline (Day 1) | 6.5 pH | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Baseline (Day 1) | 7 pH | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Week 4 | 0.5 pH | Standard Deviation 0.707 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Baseline (Day 1) | 6 pH | Standard Deviation 1.173 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Baseline (Day 1) | 5.33 pH | Standard Deviation 0.289 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Week 4 | -0.33 pH | Standard Deviation 0.289 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Week 4 | -0.24 pH | Standard Deviation 0.918 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Baseline (Day 1) | 6.16 pH | Standard Deviation 0.826 |
Primary
Change From Baseline in Pulse Rate-Part 1
Pulse rate was measured after 5 minutes of rest for the participant.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Pulse Rate-Part 1 | Baseline (Day 1) | 81 beats/minute | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Pulse Rate-Part 1 | Week 4 | 1 beats/minute | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Pulse Rate-Part 1 | Baseline (Day 1) | 83 beats/minute | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Pulse Rate-Part 1 | Week 4 | 0 beats/minute | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Pulse Rate-Part 1 | Baseline (Day 1) | 91.6 beats/minute | Standard Deviation 29.771 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Pulse Rate-Part 1 | Week 4 | -2.4 beats/minute | Standard Deviation 20.732 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Pulse Rate-Part 1 | Week 4 | 5 beats/minute | Standard Deviation 15.716 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Pulse Rate-Part 1 | Baseline (Day 1) | 79.67 beats/minute | Standard Deviation 9.074 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Pulse Rate-Part 1 | Baseline (Day 1) | 76.56 beats/minute | Standard Deviation 14.724 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Pulse Rate-Part 1 | Week 4 | 8.07 beats/minute | Standard Deviation 10.747 |
Primary
Change From Baseline in Respiratory Rate-Part 1
Respiratory rate was measured after 5 minutes of rest for the participant.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Respiratory Rate-Part 1 | Baseline (Day 1) | 18 breaths/ minute | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Respiratory Rate-Part 1 | Week 4 | 0 breaths/ minute | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Respiratory Rate-Part 1 | Baseline (Day 1) | 18 breaths/ minute | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Respiratory Rate-Part 1 | Week 4 | -2 breaths/ minute | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Respiratory Rate-Part 1 | Baseline (Day 1) | 17.6 breaths/ minute | Standard Deviation 0.894 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Respiratory Rate-Part 1 | Week 4 | 0 breaths/ minute | Standard Deviation 1.414 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Respiratory Rate-Part 1 | Week 4 | 2 breaths/ minute | Standard Deviation 0 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Respiratory Rate-Part 1 | Baseline (Day 1) | 16 breaths/ minute | Standard Deviation 0 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Respiratory Rate-Part 1 | Baseline (Day 1) | 16.75 breaths/ minute | Standard Deviation 1.065 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Respiratory Rate-Part 1 | Week 4 | 0.07 breaths/ minute | Standard Deviation 1.668 |
Primary
Change From Baseline in Specific Gravity of Urine-Part 1
Urine samples were collected to assess change from baseline in specific gravity of urine.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Week 4 | 0.005 Ratio | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Baseline (Day 1) | 1.015 Ratio | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Baseline (Day 1) | 1.02 Ratio | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Week 4 | -0.0055 Ratio | Standard Deviation 0.00666 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Baseline (Day 1) | 1.0204 Ratio | Standard Deviation 0.00856 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Baseline (Day 1) | 1.021 Ratio | Standard Deviation 0.01015 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Week 4 | 0.0013 Ratio | Standard Deviation 0.00115 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Week 4 | -0.0005 Ratio | Standard Deviation 0.006 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Specific Gravity of Urine-Part 1 | Baseline (Day 1) | 1.0159 Ratio | Standard Deviation 0.00605 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1
SBP and DBP were measured after 5 minutes of rest for the participant.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Baseline (Day 1) | 104 Millimeters of mercury (mmHg) | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Week 4 | 16 Millimeters of mercury (mmHg) | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Baseline (Day 1) | 73 Millimeters of mercury (mmHg) | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Week 4 | 4 Millimeters of mercury (mmHg) | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Baseline (Day 1) | 128 Millimeters of mercury (mmHg) | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Week 4 | -3 Millimeters of mercury (mmHg) | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Week 4 | -12 Millimeters of mercury (mmHg) | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Baseline (Day 1) | 79 Millimeters of mercury (mmHg) | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Week 4 | -5 Millimeters of mercury (mmHg) | Standard Deviation 3.162 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Week 4 | -10 Millimeters of mercury (mmHg) | Standard Deviation 11.726 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Baseline (Day 1) | 83.4 Millimeters of mercury (mmHg) | Standard Deviation 8.081 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Baseline (Day 1) | 128 Millimeters of mercury (mmHg) | Standard Deviation 14.967 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Baseline (Day 1) | 133.67 Millimeters of mercury (mmHg) | Standard Deviation 11.676 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Week 4 | -12 Millimeters of mercury (mmHg) | Standard Deviation 11.533 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Week 4 | -4 Millimeters of mercury (mmHg) | Standard Deviation 6.557 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Baseline (Day 1) | 74.67 Millimeters of mercury (mmHg) | Standard Deviation 4.041 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Week 4 | -2.8 Millimeters of mercury (mmHg) | Standard Deviation 7.552 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | DBP, Baseline (Day 1) | 76.25 Millimeters of mercury (mmHg) | Standard Deviation 9.015 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Week 4 | -0.27 Millimeters of mercury (mmHg) | Standard Deviation 19.568 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP, Baseline (Day 1) | 127.5 Millimeters of mercury (mmHg) | Standard Deviation 16.415 |
Primary
Change From Baseline in Temperature-Part 1
Temperature was measured after 5 minutes of rest for the participant.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Temperature-Part 1 | Baseline (Day 1) | 36.5 Celsius (C) | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Temperature-Part 1 | Week 4 | 0 Celsius (C) | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Temperature-Part 1 | Baseline (Day 1) | 36.9 Celsius (C) | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Temperature-Part 1 | Week 4 | -0.3 Celsius (C) | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Temperature-Part 1 | Baseline (Day 1) | 36.8 Celsius (C) | Standard Deviation 0.212 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Temperature-Part 1 | Week 4 | 0.04 Celsius (C) | Standard Deviation 0.321 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Temperature-Part 1 | Week 4 | 0.2 Celsius (C) | Standard Deviation 0.1 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Temperature-Part 1 | Baseline (Day 1) | 36.6 Celsius (C) | Standard Deviation 0.173 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Temperature-Part 1 | Baseline (Day 1) | 36.64 Celsius (C) | Standard Deviation 0.479 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Temperature-Part 1 | Week 4 | 0.04 Celsius (C) | Standard Deviation 0.378 |
Primary
Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1
Blood samples were collected to assess change from Baseline in TSH.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Baseline (Day 1) | 0.79 milliUnits/Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Baseline (Day 1) | 1.22 milliUnits/Liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Baseline (Day 1) | 1.856 milliUnits/Liter | Standard Deviation 1.6061 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Baseline (Day 1) | 1.463 milliUnits/Liter | Standard Deviation 1.2079 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Week 4 | -0.87 milliUnits/Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Baseline (Day 1) | 2.211 milliUnits/Liter | Standard Deviation 1.7527 |
Primary
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1
Blood samples were collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline.
Time frame: Baseline (Day 1) and Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Week 4 | 0.15 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Week 4 | 1.5 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Week 4 | -1 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Baseline (Day 1) | 2.37 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Baseline (Day 1) | 6.7 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Baseline (Day 1) | 138 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Week 4 | -0.3 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Baseline (Day 1) | 4.3 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Baseline (Day 1) | 3.4 millimoles/Liter | — |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Week 4 | -0.3 millimoles/Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Baseline (Day 1) | 3.3 millimoles/Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Baseline (Day 1) | 2.24 millimoles/Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Baseline (Day 1) | 4 millimoles/Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Baseline (Day 1) | 7.3 millimoles/Liter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Baseline (Day 1) | 140 millimoles/Liter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Week 4 | 0.2 millimoles/Liter | Standard Deviation 1.3 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Baseline (Day 1) | 6.09 millimoles/Liter | Standard Deviation 1.6994 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Week 4 | -0.365 millimoles/Liter | Standard Deviation 1.3225 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Baseline (Day 1) | 2.325 millimoles/Liter | Standard Deviation 0.1221 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Week 4 | 0.137 millimoles/Liter | Standard Deviation 0.1385 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Baseline (Day 1) | 4.18 millimoles/Liter | Standard Deviation 0.606 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Week 4 | 0.04 millimoles/Liter | Standard Deviation 0.586 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Baseline (Day 1) | 137.2 millimoles/Liter | Standard Deviation 4.49 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Baseline (Day 1) | 6.36 millimoles/Liter | Standard Deviation 1.226 |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Week 4 | -1.37 millimoles/Liter | Standard Deviation 1.09 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Week 4 | 0.05 millimoles/Liter | Standard Deviation 0.1322 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Week 4 | -0.03 millimoles/Liter | Standard Deviation 0.306 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Baseline (Day 1) | 2.397 millimoles/Liter | Standard Deviation 0.1475 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Baseline (Day 1) | 137.3 millimoles/Liter | Standard Deviation 3.21 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Week 4 | -0.848 millimoles/Liter | Standard Deviation 0.4949 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Week 4 | 0.7 millimoles/Liter | Standard Deviation 0.58 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Baseline (Day 1) | 5.897 millimoles/Liter | Standard Deviation 0.2754 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Week 4 | 1.08 millimoles/Liter | Standard Deviation 0.357 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Baseline (Day 1) | 7.36 millimoles/Liter | Standard Deviation 0.75 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Baseline (Day 1) | 4.3 millimoles/Liter | Standard Deviation 0.173 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Week 4 | -0.028 millimoles/Liter | Standard Deviation 0.0878 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Week 4 | -1 millimoles/Liter | Standard Deviation 2.65 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Week 4 | -0.01 millimoles/Liter | Standard Deviation 0.328 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Calcium, Baseline (Day 1) | 2.33 millimoles/Liter | Standard Deviation 0.0886 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Baseline (Day 1) | 6.397 millimoles/Liter | Standard Deviation 1.5963 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Week 4 | -0.51 millimoles/Liter | Standard Deviation 1.633 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Potassium, Baseline (Day 1) | 4.22 millimoles/Liter | Standard Deviation 0.391 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Sodium, Baseline (Day 1) | 137.1 millimoles/Liter | Standard Deviation 3.52 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Glucose, Week 4 | -0.11 millimoles/Liter | Standard Deviation 1.0164 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Urea, Baseline (Day 1) | 6.92 millimoles/Liter | Standard Deviation 3.495 |
Primary
Number of Participants With Abnormal Urinalysis Parameters-Part 1
The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose in urine. Positive test results were considered as abnormal. Number of participants with positive test results have been summarized.
Time frame: Week 4
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Glucose | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Protein | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Occult Blood | 1 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Ketones | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Protein | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Occult Blood | 2 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Ketones | 4 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Glucose | 1 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Occult Blood | 1 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Protein | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Ketones | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Glucose | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Ketones | 3 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Protein | 6 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Glucose | 2 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | Dip stick test for Occult Blood | 5 Participants |
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs.
Time frame: Up to 4 years
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AEs | 1 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AESIs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AEs | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AESIs | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | SAEs | 3 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AEs | 5 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AESIs | 2 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AEs | 3 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AESIs | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | SAEs | 3 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | SAEs | 6 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AEs | 16 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | AESIs | 7 Participants |
Primary
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1
The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE.
Time frame: Up to 4 years
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: SAEs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: SAEs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: SAEs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AEs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AESI | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AEs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AESI | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AEs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AESI | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AESI | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AEs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AEs | 1 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AESI | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: SAEs | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AESI | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AESI | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AESI | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AEs | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AESI | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AESI | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AEs | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: SAEs | 2 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AEs | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AEs | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AEs | 3 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AEs | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AEs | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: SAEs | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: SAEs | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: SAEs | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: SAEs | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AESI | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AESI | 2 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AESI | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AESI | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AESI | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AESI | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AEs | 3 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: SAEs | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AESI | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AEs | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AEs | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AEs | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AESI | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: SAEs | 3 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AEs | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AESI | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: SAEs | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AESI | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: SAEs | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: SAEs | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: SAEs | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AESI | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: SAEs | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AEs | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AEs | 4 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: AESI | 3 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 4: AEs | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AESI | 2 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AEs | 6 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 5: AESI | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: AESI | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: AEs | 4 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 3: SAEs | 3 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 2: SAEs | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | Grade 1: SAEs | 0 Participants |
Primary
Number of Participants With DLTs According to Severity-Part 1
The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE.
Time frame: Up to 28 days
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 4 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 1 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 5 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 2 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 3 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 4 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 3 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 2 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 5 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 1 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 3 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 1 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 2 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 4 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 5 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 5 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 1 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 4 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 3 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 2 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 3 | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 4 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 1 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 5 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With DLTs According to Severity-Part 1 | Grade 2 | 0 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1
A DLT is considered by the investigator to be clinically relevant, attributed event within first 28 days of intervention meeting the following criteria of toxicity, Hematologic: Febrile neutropenia, Grade 4 neutropenia of greater than (\>) 7 days in duration or requiring Granulocyte- Colony stimulating factor (G-CSF), Grade 4 anemia and Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; Non-hematologic: Grade 4 toxicity, Grade 3 pneumonitis, any greater than or equal to (≥) Grade 2 pneumonitis that does not resolve to less than or equal to (≤ ) Grade 1 within 3 days of the initiation of maximal supportive care, Grade 3 toxicity that does not resolve to Grade 1 or baseline within 3 days despite optimal supportive care and any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity.
Time frame: Up to 28 days
Population: All Treated Population includes all participants who received at least 1 dose of Tremelimumab or Feladilimab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1 | 1 Participants |
Primary
Number of Participants With Electrocardiogram (ECG) Findings
Single 12-lead ECG was obtained using an automated ECG machine. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator.
Time frame: Baseline (Pre dose, Day 1) and up to 4 Years
Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Normal | 1 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal CS | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal NCS | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Normal | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal CS | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal NCS | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal CS | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal NCS | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Normal | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal NCS | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Normal | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal CS | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Normal | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal CS | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Normal | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal NCS | 3 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal CS | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal NCS | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Normal | 1 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal CS | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal NCS | 2 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal NCS | 1 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal CS | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Normal | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal CS | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal NCS | 10 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Abnormal CS | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Abnormal NCS | 2 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Worst case Post-Baseline | Normal | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Electrocardiogram (ECG) Findings | Baseline (Pre dose, Day 1) | Normal | 6 Participants |
Primary
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1
The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized.
Time frame: Up to 4 years
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Delay | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Delay | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Delay | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Delay | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Withdrawal | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Delay | 3 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Withdrawal | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Delay | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Delay | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Withdrawal | 2 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Withdrawal | 3 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe SAEs-Dose Delay | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Withdrawal | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Delay | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Severe Aes-Dose Delay | 4 Participants |
Primary
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1
The number of participants with AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized.
Time frame: Up to 4 years
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Delay | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Delay | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Delay | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Delay | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Withdrawal | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Delay | 3 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Withdrawal | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Delay | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Delay | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Withdrawal | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Delay | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Withdrawal | 2 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Withdrawal | 3 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any SAEs-Dose Delay | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Withdrawal | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Delay | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any DLTs-Dose Modification | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | Any Aes-Dose Delay | 4 Participants |
Primary
Overall Survival-Part 2
For participants in Part 2, overall survival is defined as time from the date of randomization to the date of death due to any cause.
Time frame: Up to 4 years
Population: Intent-To-Treat population includes all participants in Part 2 who were planned to be randomized in the trial. Part 1 participants that were dosed at the dose level chosen for expansion in Part 2 were planned to be excluded from the Part 2 ITT. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1
Blood samples were collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose, end of infusion and 4 hours post dose at Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1 | 545097.4 nanograms*hours/milliLiter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1 | 453561.5 nanograms*hours/milliLiter | Geometric Coefficient of Variation 11.7 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1 | 4552653.1 nanograms*hours/milliLiter | Geometric Coefficient of Variation 18.5 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1 | 1055659.5 nanograms*hours/milliLiter | Geometric Coefficient of Variation 23.5 |
Secondary
AUC(0-t) of Feladilimab-Part 2
Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25, and 4 hours post-infusion at Week 1
Population: Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
AUC(0-t) of Tremelimumab-Part 1
Blood samples were collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose, end of infusion and 4 hours post dose at Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | AUC(0-t) of Tremelimumab-Part 1 | 18160725.7 nanograms*hours/milliLiter | Geometric Coefficient of Variation 23.4 |
Secondary
AUC(0-t) of Tremelimumab-Part 2
Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment
Time frame: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1
Population: Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Albumin and Total Protein Levels-Part 2
Blood samples will be collected to assess change from baseline in albumin and total protein levels.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in ALT, AST, ALP, LDH Levels-Part 2
Blood samples will be collected to assess change from baseline in ALT, AST ALP, LDH, amylase and lipase levels.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Amylase and Lipase Levels-Part 2
Blood samples were collected to assess change from baseline in amylase and lipase levels.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Creatinine and Bilirubin Levels-Part 2
Blood samples will be collected to assess change from baseline in creatinine and bilirubin levels.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in ECG Measurement-Part 2
Single 12-lead ECG will be obtained using an automated ECG machine.
Time frame: Baseline (Pre-dose) up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Erythrocytes Count-Part 2
Blood samples will be collected to assess change from Baseline in erythrocytes count.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Free T3-Part 2
Blood samples will be collected to assess change from baseline in free T3.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Free T4-Part 2
Blood samples will be collected to assess change from baseline in free T4.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Hematocrit Level-Part 2
Blood samples will be collected to assess change from baseline in hematocrit level.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Hemoglobin Level-Part 2
Blood samples will be collected to assess change from baseline in hemoglobin level.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 2
Blood samples will be collected to assess change from baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Oxygen Saturation-Part 2
Oxygen saturation will be measured using pulse oximetry after 5 minutes of rest for the participant.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in pH of Urine-Part 2
Urine samples will be collected to assess change from baseline in pH of urine.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Pulse Rate-Part 2
Pulse rate will be measured after 5 minutes of rest for the participant.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Respiratory Rate-Part 2
Respiratory rate will be measured after 5 minutes of rest for the participant.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in SBP and DBP-Part 2
SBP and DBP will be measured after 5 minutes of rest for the participant.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Specific Gravity of Urine-Part 2
Urine samples will be collected to assess change from Baseline in specific gravity of urine.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Temperature-Part 2
Temperature will be measured after 5 minutes of rest for the participant.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in TSH-Part 2
Blood samples will be collected to assess change from Baseline in TSH.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels -Part 2
Blood samples will be collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline.
Time frame: Baseline and up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Cmax of Feladilimab-Part 2
Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1
Population: Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Cmax of Tremelimumab-Part 1
Blood samples were collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose, end of infusion and 4 hours post dose at Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Cmax of Tremelimumab-Part 1 | 0 nanograms/milliliter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Cmax of Tremelimumab-Part 1 | 0 nanograms/milliliter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Cmax of Tremelimumab-Part 1 | 112312.1 nanograms/milliliter | Geometric Coefficient of Variation 8.2 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Cmax of Tremelimumab-Part 1 | 93206.7 nanograms/milliliter | Geometric Coefficient of Variation 24.8 |
Secondary
Cmax of Tremelimumab-Part 2
Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1
Population: Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Cmin of Feladilimab-Part 2
Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1
Population: Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Cmin of Tremelimumab-Part 1
Blood samples were collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose, end of infusion and 4 hours post dose at Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Cmin of Tremelimumab-Part 1 | 6467 nanograms/ milliliter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Cmin of Tremelimumab-Part 1 | 22466.3 nanograms/ milliliter | Geometric Coefficient of Variation 58.4 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Cmin of Tremelimumab-Part 1 | 5715.6 nanograms/ milliliter | Geometric Coefficient of Variation 43.9 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Cmin of Tremelimumab-Part 1 | 15084.9 nanograms/ milliliter | Geometric Coefficient of Variation 48.4 |
Secondary
Cmin of Tremelimumab-Part 2
Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1
Population: Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Disease Control Rate-Part 1
Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1.
Time frame: Up to 4 years
Population: All Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Disease Control Rate-Part 1 | 0 Percentage of Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Disease Control Rate-Part 1 | 0 Percentage of Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Disease Control Rate-Part 1 | 0 Percentage of Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Disease Control Rate-Part 1 | 33.3 Percentage of Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Disease Control Rate-Part 1 | 12.5 Percentage of Participants |
Secondary
Disease Control Rate-Part 2
Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1.
Time frame: Up to 4 years
Population: Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Duration of Response-Part 2
Duration of response is defined as time from the first documented evidence of response until the first documented sign of disease progression or death among participants who achieve a response (CR \[Disappearance of all target lesions. Any pathological lymph nodes {whether target or non-target} must have reduction in short axis to \<10 mm or PR \[At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters\] as per RECIST version 1.1).
Time frame: Up to 4 years
Population: Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1
Blood samples were collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose, end of infusion and 4 hours post dose at Day 1
Population: Pharmacokinetic (PK) Population includes all participants from the All Treated population for whom at least one PK sample was obtained, analysed and measurable.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1 | 2758 nanograms/milliliter | — |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1 | 5965 nanograms/milliliter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1 | 2686.6 nanograms/milliliter | Geometric Coefficient of Variation 25.7 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1 | 28340.9 nanograms/milliliter | Geometric Coefficient of Variation 12.3 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1 | 6098.3 nanograms/milliliter | Geometric Coefficient of Variation 25.3 |
Secondary
Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1
Blood samples were collected at indicated time points for pharmacokinetic assessment.
Time frame: Pre-dose, end of infusion and 4 hours post dose at Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1 | 462 nanograms/ milliliter | — |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1 | 348 nanograms/ milliliter | Geometric Coefficient of Variation 14.2 |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1 | 3197 nanograms/ milliliter | Geometric Coefficient of Variation 31 |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1 | 856.4 nanograms/ milliliter | Geometric Coefficient of Variation 35.9 |
Secondary
Number of Participants With Abnormal Urinalysis Parameters-Part 2
The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose. Positive test results were considered as abnormal. Number of participants with positive test results were planned to be summarized.
Time frame: Up to 2 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Number of Participants With AEs, SAEs, AESIs Based on Severity-Part 2
The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE
Time frame: Up to 4 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Number of Participants With AEs, SAEs and AESI-Part 2
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs.
Time frame: Up to 4 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1
Serum samples were collected and tested for the presence of antibodies to feladilimab.
Time frame: Pre-dose at Week 4, 7, 10 and 13
Population: All Treated population. Only those participants with data available at specified time points has been analyzed. Number of participants analyzed refers to the analysis population. Number analyzed at each time point refers to the participants for whom screening assays were conducted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 4 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 7 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 10 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 4 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 7 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 10 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 7 | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 10 | 1 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 4 | 1 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 4 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 7 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 10 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 13 | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 10 | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 7 | 2 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Week 4 | 5 Participants |
Secondary
Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 2
Serum samples will be collected and tested for the presence of antibodies to feladilimab.
Time frame: Up to 2.5 years
Population: ITT Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1
Serum samples were collected and tested for the presence of antibodies to tremelimumab.
Time frame: Pre-dose at Week 1, 4, 7, 10 and 13
Population: All Treated population. Only those participants with data available at specified time points has been analyzed. Number of participants analyzed refers to the analysis population. Number analyzed at each time point refers to the participants for whom screening assays were conducted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 10 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 1 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 4 | 0 Participants |
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 7 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 10 | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 7 | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 4 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 1 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 7 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 1 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 4 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 10 | 0 Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 1 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 10 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 7 | 0 Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 4 | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 7 | 1 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 10 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 1 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 13 | 0 Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Week 4 | 2 Participants |
Secondary
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 2
Serum samples will be collected and tested for the presence of antibodies to tremelimumab.
Time frame: Up to 2.5 years
Population: ITT Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 2
The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were planned to be summarized.
Time frame: Up to 4 years
Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Overall Response Rate-Part 1
Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 millimeter \[mm\]) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per response evaluation criteria in solid tumors (RECIST) version 1.1.
Time frame: Up to 4 years
Population: All Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | Overall Response Rate-Part 1 | 0 Percentage of Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | Overall Response Rate-Part 1 | 0 Percentage of Participants |
| Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | Overall Response Rate-Part 1 | 0 Percentage of Participants |
| Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | Overall Response Rate-Part 1 | 0 Percentage of Participants |
| Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | Overall Response Rate-Part 1 | 6.3 Percentage of Participants |
Secondary
Overall Response Rate-Part 2
Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per RECIST version 1.1.
Time frame: Up to 4 years
Population: Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Progression Free Survival-Part 2
For Part 2, progression free survival duration is defined as the time from the date of randomization to first documented evidence of disease progression (At least a 20% increase in the sum of diameters of target lesions and In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm) or death (regardless of cause of death), whichever comes first as per RECIST version 1.1.
Time frame: Up to 4 years
Population: Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
Secondary
Time to Response-Part 2
Time to response is defined as the time from the first dose to the first documented evidence of complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) for participants with a confirmed CR or PR as per RECIST version 1.1.
Time frame: Up to 4 years
Population: Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.