Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

Phase 1

Completed

Conditions: Neoplasms

Interventions: Drug: feladilimab (GSK3359609)
Drug: GSK3174998
Drug: Pembrolizumab
Drug: Docetaxel
Drug: Dostarlimab
Drug: Bintrafusp alfa
Drug: Pemetrexed
Drug: Cobolimab
Drug: Paclitaxel plus Carboplatin
Drug: Gemcitabine plus Carboplatin
Drug: Fluorouracil (5-FU) plus carboplatin or cisplatin

Registration Number: NCT02723955

Lead Sponsor: GlaxoSmithKline

Brief Summary: GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or chemotherapy or pembrolizumab plus chemotherapy or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 829

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1B: Expansion feladilimab (GSK3359609)	feladilimab (GSK3359609)	Participants will receive feladilimab (GSK3359609) administered continuously at a dose level chosen for further exploration in dose expansion cohorts.
Part 2B: Expansion-feladilimab (GSK3359609)	feladilimab (GSK3359609)	Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.
Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy)	Fluorouracil (5-FU) plus carboplatin or cisplatin	Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.
Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy)	feladilimab (GSK3359609)	Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.
Part 2A: Dose escalation (feladilimab (GSK3359609)+ dostarlimab)	feladilimab (GSK3359609)	Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab.
Part 1A: Dose escalation feladilimab (GSK3359609)	feladilimab (GSK3359609)	Participants will receive feladilimab (GSK3359609) administered continuously at a dose level dependent on to which dose level the participant is accrued.
Part 2A: Dose escalation (feladilimab (GSK3359609)+pembrolizumab)	feladilimab (GSK3359609)	Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.
Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy)	Paclitaxel plus Carboplatin	Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.
Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy)	Gemcitabine plus Carboplatin	Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.
Part 2A: Dose escalation (feladilimab (GSK3359609)+GSK3174998)	feladilimab (GSK3359609)	Participants will receive feladilimab (GSK3359609) administered continuously in combination with GSK3174998.
Part 2A: Dose escalation (feladilimab (GSK3359609)+GSK3174998)	GSK3174998	Participants will receive feladilimab (GSK3359609) administered continuously in combination with GSK3174998.
Part 2A: Dose escalation (feladilimab (GSK3359609)+dostarlimab+cobolimab)	feladilimab (GSK3359609)	Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab followed by cobolimab.
Part 2A: Dose escalation (feladilimab (GSK3359609)+bintrafusp alfa)	feladilimab (GSK3359609)	Participants will receive feladilimab (GSK3359609) administered continuously in combination with bintrafusp alfa.
Part 2A: Dose escalation (feladilimab (GSK3359609)+pembrolizumab)	Pembrolizumab	Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.
Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy)	Docetaxel	Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.
Part 2A: Safety run-in (feladilimab (GSK3359609)+chemotherapy)	Pemetrexed	Participants participating in Part 2A chemotherapy combination cohorts will receive feladilimab (GSK3359609) in combination with chemotherapy at doses and schedules based on standard of care practice.
Part 2B: Expansion-feladilimab (GSK3359609)	Pembrolizumab	Participants will receive feladilimab (GSK3359609) administered continuously in combination with pembrolizumab.
Part 2A: Dose escalation (feladilimab (GSK3359609)+ dostarlimab)	Dostarlimab	Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab.
Part 2A: Dose escalation (feladilimab (GSK3359609)+bintrafusp alfa)	Bintrafusp alfa	Participants will receive feladilimab (GSK3359609) administered continuously in combination with bintrafusp alfa.
Part 2A: Dose escalation (feladilimab (GSK3359609)+dostarlimab+cobolimab)	Dostarlimab	Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab followed by cobolimab.
Part 2A: Dose escalation (feladilimab (GSK3359609)+dostarlimab+cobolimab)	Cobolimab	Participants will receive feladilimab (GSK3359609) administered continuously in combination with dostarlimab followed by cobolimab.

Primary Outcome Measures

Name	Time	Method
Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)	Up to approximately 367 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. 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, or is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Part 1A: Number of Participants With Dose Limiting Toxicity (DLT)	Up to 28 days	DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28-day DLT period and meets at least one of the DLT criteria: Febrile neutropenia; Grade 4 neutropenia of \>7 days in duration or requiring Granulocyte Colony-stimulating Factor (G-CSF), anemia, thrombocytopenia, non-hematologic toxicity; Grade 3 thrombocytopenia with bleeding, pneumonitis, toxicity that does not resolve to Grade 1 or baseline within 3 days; Grade 2 ocular toxicity; Toxicity that results in permanent discontinuation of feladilimab during the first four weeks of treatment; any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT.
Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters	Baseline (Day 1) and up to approximately 367 weeks	Blood samples were collected for analysis of clinical chemistry parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit.
Part 1A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Normal ranges were 0.1 to 0.3 micromoles (umol)/liter (L) (direct bilirubin); 6 to 8.3 grams/L (protein); 100 to 250 international units (IU)/L (Lactate Dehydrogenase(LDH)); 2.3 - 4.1 picomoles/L (Free Triiodothyronine(T3)); 4.6 to 11.2 picomoles/L (Free Thyroxine(T4)); 0 and 0.04 microgram (ug)/L (Troponin I); 0 - 0.01 ug/L (Troponin T); 0.45 to 4.5 milliunits (Mu)/L (Thyrotropin(TSH)); and 6 to 24 millimoles/L (Urea). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters	Baseline (Day 1) and up to approximately 367 weeks	Blood samples were collected for analysis of hematology parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit.
Part 1A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils), 0 to 500 cells /L (eosinophils), 41 to 50 percentage of red blood cells (RBC) in blood (hematocrit), 1,000 - 4,800 lymphocytes per microliter (ÂµL) of blood (lymphocytes), 80-100 femtoliters (fl) (erythrocytes, mean corpuscular volume), 2 to 8 percentage of WBC (monocytes), 40 to 60 cells/mcL (neutrophils) and Women: 4.2 to 5.4 million RBC/ microliter (mcL) of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes count). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Part 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Urine samples were collected to assess urine glucose, ketones and occult blood using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase.
Part 1A: Number of Participants With Dose Modifications of Feladilimab	Up to approximately 367 weeks	Number of participants with dose modifications (including dose delays, dose escalations and infusion interruptions) were reported for Feladilimab.
Part 2A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)	Up to approximately 367 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. 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 or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary.
Part 2A: Number of Participants With Dose Limiting Toxicity (DLT)	Up to 28 days	DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28-day DLT period and meets at least one of the DLT criteria: Febrile neutropenia; Grade 4 neutropenia of \>7 days in duration or requiring Granulocyte Colony-stimulating Factor (G-CSF), anemia, thrombocytopenia, non-hematologic toxicity; Grade 3 thrombocytopenia with bleeding, pneumonitis, toxicity that does not resolve to Grade 1 or baseline within 3 days; Grade 2 ocular toxicity; Toxicity that results in permanent discontinuation of feladilimab monotherapy or in combination during the first four weeks of treatment; any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT.
Part 2A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters	Baseline (Day 1) and up to approximately 367 weeks	Blood samples were collected for analysis of clinical chemistry parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit.
Part 2A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Normal ranges were 6 to 8.3 grams/L (protein); 100 to 250 international units (IU)/L (Lactate Dehydrogenase(LDH)); 2.3 - 4.1 picomoles/L (Free Triiodothyronine(T3)); 4.6 to 11.2 picomoles/L (Free Thyroxine(T4)); 0 and 0.04 microgram (ug)/L (Troponin I); 0 - 0.01 ug/L (Troponin T); 0.45 to 4.5 milliunits (Mu)/L (Thyrotropin(TSH)); and 6 to 24 millimoles/L (Urea). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Part 2A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters	Baseline (Day 1) and up to approximately 367 weeks	Blood samples were collected for analysis of hematology parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit.
Part 2A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils), 0 to 500 cells /L (eosinophils), 41 to 50 percentage of RBC in blood (hematocrit), 2 to 8 percentage of WBC (monocytes), 40 to 60 cells/mcL (neutrophils) and Women: 4.2 to 5.4 million RBC/mcL of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes count). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Part 2A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Urine samples were collected to assess urine glucose, ketones and occult blood using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase.
Part 2A: Number of Participants With Dose Modifications of Feladilimab	Up to approximately 367 weeks	Number of participants with dose modifications (including dose delays, dose escalations, and infusion interruptions) were reported for Feladilimab

Secondary Outcome Measures

Name	Time	Method
Part 2B: Receptor Occupancy of Feladilimab	Up to approximately 367 weeks	Blood samples were collected to assess the cluster of differentiation 4 (CD4+) and cluster of differentiation 8 (CD8+) receptor occupancy by Feladilimab as a pharmacodynamic analysis. It was assessed using validated flow cytometry assay.
Part 1B: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)	Up to approximately 367 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. 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 or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary.
Part 1B: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters	Baseline (Day 1) and up to approximately 367 weeks	Blood samples were collected for analysis of clinical chemistry parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit.
Part 2B: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters	Baseline (Day 1) and up to approximately 367 weeks	Blood samples were collected for analysis of hematology parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit.
Part 1B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Normal ranges were 6 to 8.3 grams/L (protein); 100 to 250 international units (IU)/L (Lactate Dehydrogenase(LDH)); 2.3 - 4.1 picomoles/L (Free Triiodothyronine(T3)); 4.6 to 11.2 picomoles/L (Free Thyroxine(T4)); 0 and 0.04 microgram (ug)/L (Troponin I); 0 - 0.01 ug/L (Troponin T); 0.45 to 4.5 milliunits (Mu)/L (Thyrotropin(TSH)); and 6 to 24 millimoles/L (Urea). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%
Part 1B: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters	Baseline (Day 1) and up to approximately 367 weeks	Blood samples were collected for analysis of hematology parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit.
Part 1B: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils), 0 to 500 cells /L (eosinophils), 41 to 50 percentage of RBC in blood (hematocrit), 2 to 8 percentage of WBC (monocytes), and Women: 4.2 to 5.4 million RBC/ mcL of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocyte count). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Part 1B: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Urine samples were collected to assess urine glucose, ketones and occult blood using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase.
Part 1B: Number of Participants With Dose Modifications of Feladilimab	Up to approximately 367 weeks	Number of participants with dose modifications (including dose delays, dose escalation and infusion interruptions) were reported for Feladilimab.
Part 2B: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)	Up to approximately 367 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. 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 or is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary.
Part 2B: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters	Baseline (Day 1) and up to approximately 367 weeks	Blood samples were collected for analysis of clinical chemistry parameters. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 0: None; G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only grade change data is presented for Baseline (B) and Worst-Case Post-Baseline (WCPB) as G0, G1, G2, G3, G4, and missing (M) here as "Parameter name, B GX, WCPB GX" where X=grade digit.
Part 2B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Normal ranges were 0.1 to 0.3 micromoles (umol)/liter (L) (direct bilirubin); 6 to 8.3 grams/L (protein); 100 to 250 international units (IU)/L (Lactate Dehydrogenase(LDH)); 2.3 - 4.1 picomoles/L (Free Triiodothyronine(T3)); 4.6 to 11.2 picomoles/L (Free Thyroxine(T4)); 0 and 0.04 microgram (ug)/L (Troponin I); 0 - 0.01 ug/L (Troponin T); 0.45 to 4.5 milliunits (Mu)/L (Thyrotropin(TSH)); 24-204 ug/L (creatine kinase); and 6 to 24 millimoles/L (Urea). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Part 2B: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils), 0 to 500 cells/L(eosinophils), 41 to 50 percentage of RBC in blood (hematocrit), 1,000 - 4,800 lymphocytes per microliter (ÂµL) of blood (lymphocytes), 80-100 fl (erythrocytes, mean corpuscular volume), 2 to 8 percentage of WBC (monocytes), 40 to 60 cells/mcL (neutrophils) and Women: 4.2 to 5.4 million RBC/ mcL of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes count). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Part 2B: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline	Up to approximately 367 weeks	Urine samples were collected to assess urine glucose, ketones and occult blood using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase.
Part 2B: Number of Participants With Dose Modifications of Feladilimab	Up to approximately 367 weeks	Number of participants with dose modifications (including dose delays, dose escalations, and infusion interruptions) were reported for Feladilimab.
Part 1A: Overall Response Rate (ORR)	Up to approximately 367 weeks	ORR was defined as the percentage of participants with immune-related confirmed complete response (irCR) or ir confirmed partial response (irPR) per Immune-related Response Evaluation Criteria in Solid Tumors Criteria (irRECIST). irCR is defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). irPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Part 1A: Disease Control Rate (DCR)	Up to approximately 367 weeks	DCR was defined as percentage of participants with best overall response of irCR or irPR at any time + ir stable disease (irSD) meeting the minimum time criteria from the start of treatment until ir disease progression (irPD) or death due to any cause or the start of new anticancer therapy/crossover. irCR is defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. irPR defined as at least 30% decrease in the sum of diameters of target lesions, taking as a reference, the baseline sum of the diameters. irSD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. IrPD defined as the date of radiological disease progression based on imaging data per irRECIST. A one-week visit window was considered in the duration of irSD, i.e. a minimum of 8 weeks (irSD\>=9 weeks) and 17 weeks (irSD\>=18 weeks) were considered.
Part 1A: Overall Survival (OS)	Up to approximately 367 weeks	OS was defined as the interval between the date of first assigned study therapy/randomization and date of death due to any cause.
Part 1A: Progression-free Survival (PFS)	Up to approximately 367 weeks	PFS was defined as the interval between the date of first dose of study treatment (or date of randomization for randomized cohorts) and the date of disease progression according to radiological response from investigator assessment, or death due to any cause, whichever occurs earlier. Disease progression was defined as the date of radiological disease progression based on imaging data per RECIST v1.1
Part 1A: Time to Overall Response (TTR)	Up to approximately 367 weeks	TTR was defined as the time from date of first dose of study treatment/randomization to the date of first documented confirmed (=4 weeks) CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Part 2A: AUC (0-504 h) of GSK3174998	Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 1A: Duration of Response (DOR)	Up to approximately 367 weeks	DOR was defined as the interval of time in months from the date of the first documented evidence of a response (confirmed CR or PR) to the date of first documented evidence of disease progression according to radiological response from investigator assessment per RECIST v1.1, or date of last adequate assessment of response or the date of death due to any cause (whichever occurs earlier). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Disease progression was defined as the date of radiological disease progression based on imaging data per RECIST v1.1.
Part 2A: Overall Response Rate (ORR)	Up to approximately 367 weeks	ORR was defined as the percentage of participants with irCR or irPR per irRECIST. irCR is defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). irPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Part 2A: Disease Control Rate (DCR)	Up to approximately 367 weeks	DCR was defined as percentage of participants with best overall response of irCR or irPR at any time + irSD meeting the minimum time criteria from the start of treatment until irPD or death due to any cause or the start of new anticancer therapy/crossover. irCR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. irPR defined as at least 30% decrease in the sum of diameters of target lesions, taking as a reference, the baseline sum of the diameters. irSD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. IrPD defined as the date of radiological disease progression based on imaging data per irRECIST. A one-week visit window was considered in the duration of irSD, i.e. a minimum of 8 weeks (irSD\>=9 weeks) and 17 weeks (irSD\>=18 weeks) were considered.
Part 2A: Overall Survival (OS)	Up to approximately 367 weeks	OS was defined as the interval between the date of first assigned study therapy/randomization and date of death due to any cause.
Part 2A: Progression-free Survival (PFS)	Up to approximately 367 weeks	PFS was defined as the interval between the date of first dose of study treatment (or date of randomization for randomized cohorts) and the date of disease progression according to radiological response from investigator assessment, or death due to any cause, whichever occurs earlier. Disease Progression was defined as the date of radiological disease progression based on imaging data per RECIST v1.1.
Part 2A: Time to Overall Response (TTR)	Up to approximately 367 weeks	TTR was defined as the time from date of first dose of study treatment/randomization to the date of first documented confirmed (=4 weeks) CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Part 2A: Duration of Response (DOR)	Up to approximately 367 weeks	DOR was defined as the interval of time in months from the date of the first documented evidence of a response (confirmed CR or PR) to the date of first documented evidence of disease progression according to radiological response from investigator assessment per RECIST v1.1, or date of last adequate assessment of response or the date of death due to any cause (whichever occurs earlier). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Disease progression is defined as the date of radiological disease progression based on imaging data per RECIST v1.1.
Part 1B: Overall Response Rate (ORR)	Up to approximately 367 weeks	ORR was defined as the percentage of participants with a confirmed irCR or confirmed irPR per irRECIST. irCR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. irPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Part 1B: Disease Control Rate (DCR)	Up to approximately 367 weeks	DCR was defined as percentage of participants with best overall response of irCR or irPR at any time + irSD meeting the minimum time criteria from the start of treatment until irPD or death due to any cause or the start of new anticancer therapy/crossover. irCR is defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. irPR defined as at least 30% decrease in the sum of diameters of target lesions, taking as a reference, the baseline sum of the diameters. irSD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. IrPD defined as the date of radiological disease progression based on imaging data per irRECIST. A one-week visit window was considered in the duration of irSD, i.e. a minimum of 8 weeks (irSD\>=9 weeks) and 17 weeks (irSD\>=18 weeks) were considered.
Part 1B: Overall Survival (OS)	Up to approximately 367 weeks	OS was defined as the interval between the date of first assigned study therapy/randomization and date of death due to any cause.
Part 1B: Progression-free Survival (PFS)	Up to approximately 367 weeks	PFS was defined as the interval between the date of first dose of study treatment (or date of randomization for randomized cohorts) and the date of disease progression according to radiological response from investigator assessment, or death due to any cause, whichever occurs earlier. Disease progression was defined as the date of radiological disease progression based on imaging data per RECIST v1.1.
Part 1B: Time to Overall Response (TTR)	Up to approximately 367 weeks	TTR was defined as the time from date of first dose of study treatment/randomization to the date of first documented confirmed (=4 weeks) CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Part 1B: Duration of Response (DOR)	Up to approximately 367 weeks	DOR was defined as the interval of time in months from the date of the first documented evidence of a response (confirmed CR or PR) to the date of first documented evidence of disease progression according to radiological response from investigator assessment per RECIST v1.1, or date of last adequate assessment of response or the date of death due to any cause (whichever occurs earlier). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Disease progression is defined as the date of radiological disease progression based on imaging data per RECIST v1.1.
Part 2B: Overall Response Rate (ORR)	Up to approximately 367 weeks	ORR was defined as the percentage of participants with a confirmed irCR or confirmed irPR per irRECIST. irCR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. irPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Part 1B: Cmax and Ctau of Feladilimab	Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours post-EOI in week 6, 9, 12 15; Pre-dose in week 21, 33 and 45	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2B: Disease Control Rate (DCR)	Up to approximately 367 weeks	DCR was defined as the percentage of participants with a best overall response of irCR or irPR at any time plus irSD meeting the minimum time criteria from the start of treatment until irPD or death due to any cause or the start of new anticancer therapy/crossover. irCR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. irPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. irSD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. irPD is defined as the date of radiological disease progression based on imaging data per irRECIST. A one-week visit window was considered in the duration of irSD, i.e. a minimum of 8 weeks (irSD\>=9 weeks) and 17 weeks (irSD\>=18 weeks) were considered.
Part 2B: Overall Survival (OS)	Up to approximately 367 weeks	OS was defined as the interval between the date of first assigned study therapy/randomization and date of death due to any cause.
Part 2B: Progression-free Survival (PFS)	Up to approximately 367 weeks	PFS was defined as the interval between the date of first dose of study treatment (or date of randomization for randomized cohorts) and the date of disease progression according to radiological response from investigator assessment, or death due to any cause, whichever occurs earlier. Disease progression was defined as the date of radiological disease progression based on imaging data per RECIST v1.1.
Part 2B: Time to Overall Response (TTR)	Up to approximately 367 weeks	TTR was defined as the time from date of first dose of study treatment/randomization to the date of first documented confirmed (=4 weeks) CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Part 2B: Duration of Response (DOR)	Up to approximately 367 weeks	DOR was defined as the interval of time in months from the date of the first documented evidence of a response (confirmed CR or PR) to the date of first documented evidence of disease progression according to radiological response from investigator assessment per RECIST v1.1, or date of last adequate assessment of response or the date of death due to any cause (whichever occurs earlier). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Disease progression is defined as the date of radiological disease progression based on imaging data per RECIST v1.1
Part 1A: Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Ctau) of Feladilimab	Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours POST EOI; week 1; week 2; Pre-dose and 0.5 hours POST EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours POST EOI in week 6, 9, 12 15; Pre-dose in week 21 and 33	Blood samples were collected for Pharmacokinetic (PK) analysis. PK analysis was calculated based on standard non-compartmental method.
Part 1A: Area Under the Concentration-time Curve From Time 0 to 504 Hours After Dosing [AUC (0-504h)] of Feladilimab	Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours post-EOI in week 6, 9, 12 15; Pre-dose in week 21 and 33	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2A: Ctau of Pembrolizumab	Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2A: AUC (0-504h) of Pembrolizumab	Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2A: Cmax and Ctau of GSK3174998	Pre-dose and 24 hours post-EOI on day 1; week 1; week 2; Pre-dose in week 3; week 4; week 5; Pre-dose in week 9, 15, 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 1B: AUC (0-504 h) of Feladilimab	Pre-dose; end of infusion (EOI); 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5 hours post-EOI in week 6, 9, 12 15; Pre-dose in week 21, 33 and 45	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2B: Cmax and Ctau of Feladilimab	Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2B: AUC (0-504 h) of Feladilimab	Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2B: AUC (0-1008 h) of Feladilimab	Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2B: Cmax and Ctau of Pembrolizumab	Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 2B: AUC (0-504h) of Pembrolizumab	Pre-dose; EOI; 0.5, 1, 2, 4, 6, 8, 24, 48-72, 96-120 hours post-EOI; week 1; week 2; Pre-dose and 0.5 hours post-EOI in week 3; week 4; week 5; Pre-dose and 0.5, 4 hours post-EOI in week 6, 9, 12 and15; Pre-dose in week 18, 21, 33, 45, 57, 69, 81 and 93	Blood samples were collected for PK analysis. PK analysis was calculated based on standard non-compartmental method.
Part 1A: Number of Participants With Positive Results in Anti-drug Antibody (ADA) Test by Feladilimab Dose Level	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab in Combination With GSK3174998 Dose Level	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level in Combination With Pembrolizumab	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 2A: Number of Participants With Positive Results in ADA in Pembrolizumab	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 2A: Number of Participants With Positive Results in ADA in GSK3174998	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 2A: Number of Participants With Positive Results in ADA Test by Feladilimab Combination With Chemotherapies Dose Level	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 1B: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 2B: Number of Participants With Positive Results in ADA Test by Feladilimab Dose Level	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 2B: Number of Participants With Positive Results in ADA in Pembrolizumab	Up to approximately 367 weeks	Serum samples collected and tested for the presence of ADA with a screening assay.
Part 1A: Receptor Occupancy of Feladilimab	Up to approximately 367 weeks	Blood samples were collected to assess the cluster of differentiation 4 (CD4+) and cluster of differentiation 8 (CD8+) receptor occupancy by Feladilimab as a pharmacodynamic analysis. It was assessed using validated flow cytometry assay.
Part 2A: Receptor Occupancy of Feladilimab	Up to approximately 367 weeks	Blood samples were collected to assess the cluster of differentiation 4 (CD4+) and cluster of differentiation 8 (CD8+) receptor occupancy by Feladilimab as a pharmacodynamic analysis. It was assessed using validated flow cytometry assay.
Part 1B: Receptor Occupancy of Feladilimab	Up to approximately 367 weeks	Blood samples were collected to assess the cluster of differentiation 4 (CD4+) and cluster of differentiation 8 (CD8+) receptor occupancy by Feladilimab as a pharmacodynamic analysis. It was assessed using validated flow cytometry assay.