GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03693612
• Collaborator: MedImmune LLC (Industry)
• Enrollment: 26
• Locations: 8
• Arms: 3
• Actual Duration (Months): 33.7
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: feladilimab; Drug: Tremelimumab; Drug: Docetaxel; Drug: Paclitaxel; Drug: Cetuximab	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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).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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II, Open-label, Two Part Study of GSK3359609 in Combination With Tremelimumab in Participants With Selected, Advanced Solid Tumors
• Actual Study Start Date: Nov 26, 2018
• Actual Primary Completion Date: Jun 25, 2021
• Actual Study Completion Date: Sep 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: feladilimab +tremelimumab In Part 1, subjects with advanced selected solid tumors will be enrolled. Subjects will be administered escalating doses of feladilimab and tremelimumab in combination. feladilimab will be administered every 3 weeks and tremelimumab will be administered every 3 weeks for 6 doses and every 12 weeks thereafter.	Drug: feladilimab; 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.; Drug: Tremelimumab; 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 .
Experimental: Part 2: feladilimab +tremelimumab In Part 2, subjects with R/R HNSCC who have disease progression after receiving at least one platinum-based chemotherapy and at least one anti-PD-1/PD-L1 will be enrolled. Subjects will be administered feladilimab in combination with tremelimumab at recommended Phase 2 dose as determined from Part 1.	Drug: feladilimab; 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.; Drug: Tremelimumab; 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 .
Active Comparator: Part 2: SOC In Part 2, subjects with R/R HNSCC who have disease progression after receiving at least one platinum-based chemotherapy and at least one anti-PD-1/PD-L1 will be enrolled. Subjects will be administered a single agent SOC therapy of either paclitaxel, docetaxel or cetuximab as per the investigators choice.	Drug: Docetaxel; 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).; Drug: Paclitaxel; Paclitaxel is a microtubule stabilizer which will be administered as an IV infusion once weekly at a dose of 80 mg/m^2.; Drug: Cetuximab; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. Change From Baseline in Temperature-Part 1 [Baseline (Day 1) and Week 4]

   Temperature was measured after 5 minutes of rest for the participant.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

27. 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.

28. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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).

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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

27. 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.

28. 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.

29. 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.

30. 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.

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.

41. 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.

42. 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.

43. 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.

44. 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.

45. 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.

46. 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.

47. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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;

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Boston	Massachusetts	United States	02215
2	GSK Investigational Site	New York	New York	United States	10016-4744
3	GSK Investigational Site	New York	New York	United States	10032
4	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15232
5	GSK Investigational Site	San Antonio	Texas	United States	78229
6	GSK Investigational Site	Melbourne	Victoria	Australia	3000
7	GSK Investigational Site	Ottawa	Ontario	Canada	K1H 8L6
8	GSK Investigational Site	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• GlaxoSmithKline
• MedImmune LLC

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Sep 20, 2018
• Statistical Analysis Plan - Dec 16, 2020

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03693612
• Other Study ID Numbers: 207871
• First Posted: Oct 3, 2018
• Last Update Posted: Aug 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: 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
• Additional relevant MeSH terms: Paclitaxel; Docetaxel; Cetuximab; Tremelimumab

Study Results

Participant Flow

Recruitment Details	The study was conducted in United States and Canada.
Pre-assignment Detail	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.

Arm/Group Title	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	Part 2: Feladilimab +Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion once every 3 weeks (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 every 12 weeks (Q12W).	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.	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.	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.	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.	In Part 2, participants with Head and Neck Squamous Cell Carcinoma (HNSCC) who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti- Programmed death receptor protein-1 (PD-1)/ Programmed death-ligand 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 Recommended Phase 2 Dose (RP2D) determination.	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 a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 milligrams per meter square (mg/m^2)), docetaxel (as an IV infusion once Q3W 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.
Period Title: Overall Study
STARTED	1	1	5	3	16	0	0
COMPLETED	1	0	4	3	10	0	0
NOT COMPLETED	0	1	1	0	6	0	0

Baseline Characteristics

Arm/Group Title	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	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)	Total
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	1	1	5	3	16	0	0	26
Age (YEARS) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [YEARS]	51.0 (0)	51.0 (0)	58.2 (11.73)	69.0 (12.77)	66.8 (11.51)	64.2 (11.95)
Sex: Female, Male (Count of Participants)
Female	1 100%	1 100%	3 60%	0 0%	4 25%	0 NaN	0 NaN	9 34.6%
Male	0 0%	0 0%	2 40%	3 100%	12 75%	0 NaN	0 NaN	17 65.4%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	0 0%	0 0%	0 0%	0 0%	1 6.3%	0 NaN	0 NaN	1 3.8%
Multiple	0 0%	0 0%	0 0%	0 0%	1 6.3%	0 NaN	0 NaN	1 3.8%
White - White/Caucasian/European Heritage	1 100%	1 100%	5 100%	3 100%	14 87.5%	0 NaN	0 NaN	24 92.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population includes all participants who received at least 1 dose of Tremelimumab or Feladilimab.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	1 6.3%

2. Primary Outcome

Title	Number of Participants With DLTs According to Severity-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	1 6.3%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 5	0 0%	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
AEs	1 100%	1 100%	5 100%	3 100%	16 100%
SAEs	0 0%	0 0%	3 60%	3 100%	6 37.5%
AESIs	0 0%	0 0%	2 40%	0 0%	7 43.8%

4. Primary Outcome

Title	Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1
Description	The number of participants with AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Any Aes-Dose Modification	0 0%	0 0%	0 0%	0 0%	0 0%
Any Aes-Dose Delay	0 0%	0 0%	3 60%	0 0%	4 25%
Any Aes-Dose Withdrawal	0 0%	0 0%	1 20%	0 0%	3 18.8%
Any SAEs-Dose Modification	0 0%	0 0%	0 0%	0 0%	0 0%
Any SAEs-Dose Delay	0 0%	0 0%	1 20%	0 0%	1 6.3%
Any SAEs-Dose Withdrawal	0 0%	0 0%	1 20%	0 0%	2 12.5%
Any DLTs-Dose Modification	0 0%	0 0%	0 0%	0 0%	0 0%
Any DLTs-Dose Delay	0 0%	0 0%	0 0%	0 0%	1 6.3%
Any DLTs-Dose Withdrawal	0 0%	0 0%	0 0%	0 0%	1 6.3%

5. Primary Outcome

Title	Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Grade 1: AEs	0 0%	0 0%	0 0%	0 0%	4 25%
Grade 2: AEs	1 100%	1 100%	1 20%	0 0%	4 25%
Grade 3: AEs	0 0%	0 0%	3 60%	3 100%	6 37.5%
Grade 4: AEs	0 0%	0 0%	1 20%	0 0%	1 6.3%
Grade 5: AEs	0 0%	0 0%	0 0%	0 0%	1 6.3%
Grade 1: SAEs	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 2: SAEs	0 0%	0 0%	0 0%	0 0%	1 6.3%
Grade 3: SAEs	0 0%	0 0%	2 40%	3 100%	3 18.8%
Grade 4: SAEs	0 0%	0 0%	1 20%	0 0%	1 6.3%
Grade 5: SAEs	0 0%	0 0%	0 0%	0 0%	1 6.3%
Grade 1: AESI	0 0%	0 0%	0 0%	0 0%	3 18.8%
Grade 2: AESI	0 0%	0 0%	2 40%	0 0%	2 12.5%
Grade 3: AESI	0 0%	0 0%	0 0%	0 0%	1 6.3%
Grade 4: AESI	0 0%	0 0%	0 0%	0 0%	1 6.3%
Grade 5: AESI	0 0%	0 0%	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1
Description	The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Any Severe Aes-Dose Modification	0 0%	0 0%	0 0%	0 0%	0 0%
Any Severe Aes-Dose Delay	0 0%	0 0%	3 60%	0 0%	4 25%
Any Severe Aes-Dose Withdrawal	0 0%	0 0%	1 20%	0 0%	3 18.8%
Any Severe SAEs-Dose Modification	0 0%	0 0%	0 0%	0 0%	0 0%
Any Severe SAEs-Dose Delay	0 0%	0 0%	1 20%	0 0%	1 6.3%
Any Severe SAEs-Dose Withdrawal	0 0%	0 0%	1 20%	0 0%	2 12.5%
Any Severe DLTs-Dose Modification	0 0%	0 0%	0 0%	0 0%	0 0%
Any Severe DLTs-Dose Delay	0 0%	0 0%	0 0%	0 0%	1 6.3%
Any Severe DLTs-Dose Withdrawal	0 0%	0 0%	0 0%	0 0%	1 6.3%

7. Primary Outcome

Title	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1
Description	SBP and DBP were measured after 5 minutes of rest for the participant.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
SBP, Baseline (Day 1)	104	128	128 (14.967)	133.67 (11.676)	127.5 (16.415)
SBP, Week 4	16	-12	-10 (11.726)	-12 (11.533)	-0.27 (19.568)
DBP, Baseline (Day 1)	73	79	83.4 (8.081)	74.67 (4.041)	76.25 (9.015)
DBP, Week 4	4	-3	-5 (3.162)	-4 (6.557)	-2.8 (7.552)

8. Primary Outcome

Title	Change From Baseline in Temperature-Part 1
Description	Temperature was measured after 5 minutes of rest for the participant.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	36.5	36.9	36.8 (0.212)	36.6 (0.173)	36.64 (0.479)
Week 4	0	-0.3	0.04 (0.321)	0.2 (0.1)	0.04 (0.378)

9. Primary Outcome

Title	Change From Baseline in Pulse Rate-Part 1
Description	Pulse rate was measured after 5 minutes of rest for the participant.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	81	83	91.6 (29.771)	79.67 (9.074)	76.56 (14.724)
Week 4	1	0	-2.4 (20.732)	5 (15.716)	8.07 (10.747)

10. Primary Outcome

Title	Change From Baseline in Respiratory Rate-Part 1
Description	Respiratory rate was measured after 5 minutes of rest for the participant.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	18	18	17.6 (0.894)	16 (0)	16.75 (1.065)
Week 4	0	-2	0 (1.414)	2 (0)	0.07 (1.668)

11. Primary Outcome

Title	Change From Baseline in Oxygen Saturation-Part 1
Description	Oxygen saturation was measured using pulse oximeter after 5 minutes of rest for the participant.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	96	95	95.6 (2.881)	96 (1.00)	97.63 (1.586)
Week 4	2	5	0.8 (1.304)	0 (2.00)	-0.2 (2.007)

12. Primary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Findings
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Normal	1 100%	1 100%	1 20%	1 33.3%	6 37.5%
Abnormal CS	0 0%	0 0%	1 20%	0 0%	0 0%
Abnormal NCS	0 0%	0 0%	3 60%	2 66.7%	10 62.5%
Normal	0 0%	0 0%	0 0%	1 33.3%	0 0%
Abnormal CS	0 0%	0 0%	0 0%	0 0%	0 0%
Abnormal NCS	0 0%	0 0%	0 0%	1 33.3%	2 12.5%

13. Primary Outcome

Title	Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Basophils, Baseline (Day 1)	0.00	0.00	0.05 (0.0577)	0.01 (0.0141)	0.039 (0.048)
Basophils, Week 4	0.00	0 (0)	0.005 (0.0071)	0.007 (0.0344)
Eosinophils, Baseline (Day 1)	0.3	0.1	0.35 (0.173)	0.08 (0.113)	0.2 (0.217)
Eosinophils, Week 4	0.4	0.03 (0.15)	0.06 (0.064)	0.07 (0.169)
Lymphocytes, Baseline (Day 1)	1	1.5	0.9 (0.216)	1.25 (0.212)	0.92 (0.223)
Lymphocytes, Week 4	0.4	0.23 (0.15)	-0.38 (0.46)	0.01 (0.185)
Monocytes, Baseline (Day 1)	0.4	0.3	0.8 (0.2944)	1.255 (0.9122)	0.738 (0.3004)
Monocytes, Week 4	0	0.05 (0.1732)	-0.215 (0.1202)	0.038 (0.2598)
Neutrophils, Baseline (Day 1)	4	3.9	4.38 (1.548)	6.2 (2.97)	11.32 (21.379)
Neutrophils, Week 4	0.3	0.93 (0.512)	-0.9 (0.7)	-8.95 (26.151)
Platelets, Baseline (Day 1)	196	325	250.6 (103.5)	229.7 (147.06)	266.3 (90.28)
Platelets, Week 4	-1	8.6 (34.93)	-8.7 (16.65)	31.3 (42.72)

14. Primary Outcome

Title	Change From Baseline in Hemoglobin Level-Part 1
Description	Blood samples were collected to assess change from baseline in hemoglobin level.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	125	134	123.4 (32.61)	125 (23.07)	111.5 (12.74)
Week 4	5	-5.8 (4.21)	0.3 (2.89)	-0.7 (10.78)

15. Primary Outcome

Title	Change From Baseline in Hematocrit Level-Part 1
Description	Blood samples were collected to assess change from baseline in hematocrit level.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	0.38	0.4	0.385 (0.10999)	0.3937 (0.0647)	0.3421 (0.03603)
Week 4	0	-0.0202 (0.01494)	-0.0017 (0.01102)	-0.0039 (0.03413)

16. Primary Outcome

Title	Change From Baseline in Erythrocytes Count-Part 1
Description	Blood samples were collected to assess change from baseline in Erythrocytes count.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	4.2	4.65	4.328 (1.2592)	4.673 (0.4885)	3.76 (0.526)
Week 4	0.13	-0.216 (0.2131)	0.04 (0.1652)	0.016 (0.3913)

17. Primary Outcome

Title	Change From Baseline in Albumin and Total Protein Levels-Part 1
Description	Blood samples were collected to assess change from Baseline in albumin and total protein levels.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Albumin, Baseline (Day 1)	41	40	36 (7.18)	36.7 (9.24)	37.9 (2.79)
Albumin, Week 4	0	0 (3.81)	-0.7 (2.31)	-2.1 (2.81)
Protein, Baseline (Day 1)	71	66.7 (7.02)	73 (3.61)	72.1 (6.51)
Protein, Week 4	3.3 (2.89)	0 (4.36)	1.4 (4.31)

18. Primary Outcome

Title	Change From Baseline in Creatinine and Bilirubin Levels-Part 1
Description	Blood samples were collected to assess change from baseline in creatinine and bilirubin levels.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Bilirubin, Baseline (Day 1)	5	7	6.1 (2.44)	6.1 (2.84)	6.5 (4.23)
Bilirubin, Week 4	-1	2.2 (2.48)	-1.1 (1.97)	-0.4 (1.52)
Creatinine, Baseline (Day 1)	59000	63000	31636.7 (43702.44)	73.5 (33.52)	93 (44.72)
Creatinine, Week 4	1000	-1798.9 (3493.56)	3.1 (4.29)	-2.9 (9.53)

19. Primary Outcome

Title	Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1
Description	Blood samples were collected to assess change from baseline in ALT, AST ALP, LDH levels.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
ALP, Baseline (Day 1)	53	68	307.4 (416.93)	121.5 (82.73)	120.2 (60.54)
ALP, Week 4	2	55.8 (101.74)	-18 (25.46)	36.2 (75.58)
ALT, Baseline (Day 1)	18	25	24 (14.18)	26.7 (24.79)	18.2 (13.49)
ALT, Week 4	-2	8.2 (13.05)	-4.7 (15.14)	7.4 (26.46)
AST, Baseline (Day 1)	32	44	24.6 (9.91)	23.7 (15.89)	21.9 (8.23)
AST, Week 4	0	10 (14.2)	-7 (14.73)	12.9 (35.1)
LDH, Baseline (Day 1)	325	382	228.8 (20.69)	168 (104.23)	239.9 (139.36)
LDH, Week 4	127	11.4 (42.76)	31.3 (53.3)	42.9 (85.66)

20. Primary Outcome

Title	Change From Baseline in Amylase and Lipase Levels-Part 1
Description	Blood samples were collected to assess change from baseline in amylase and lipase levels.
Time Frame	Baseline (Day 1) and week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Amylase, Baseline (Day 1)	48	50	50.2 (34.85)	40 (15.62)	51.5 (26.72)
Amylase, Week 4	-2	-5.3 (7.23)	-5 (1)	-3.5 (9.64)
Lipase, Baseline (Day 1)	28	23	50.8 (55.65)	54.7 (48.99)	34.6 (27.8)
Lipase, Week 4	0	1.5 (4.65)	-13 (23.81)	6.1 (35.96)

21. Primary Outcome

Title	Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Glucose, Baseline (Day 1)	6.7	7.3	6.09 (1.6994)	5.897 (0.2754)	6.397 (1.5963)
Glucose, Week 4	-0.3	-0.365 (1.3225)	-0.848 (0.4949)	-0.11 (1.0164)
Calcium, Baseline (Day 1)	2.37	2.24	2.325 (0.1221)	2.397 (0.1475)	2.33 (0.0886)
Calcium, Week 4	0.15	0.137 (0.1385)	0.05 (0.1322)	-0.028 (0.0878)
Potassium, Baseline (Day 1)	4.3	4	4.18 (0.606)	4.3 (0.173)	4.22 (0.391)
Potassium, Week 4	-0.3	0.04 (0.586)	-0.03 (0.306)	-0.01 (0.328)
Sodium, Baseline (Day 1)	138	140	137.2 (4.49)	137.3 (3.21)	137.1 (3.52)
Sodium, Week 4	-1	0.2 (1.3)	0.7 (0.58)	-1 (2.65)
Urea, Baseline (Day 1)	3.4	3.3	6.36 (1.226)	7.36 (0.75)	6.92 (3.495)
Urea, Week 4	1.5	-1.37 (1.09)	1.08 (0.357)	-0.51 (1.633)

22. Primary Outcome

Title	Change From Baseline in Specific Gravity of Urine-Part 1
Description	Urine samples were collected to assess change from baseline in specific gravity of urine.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	1.015	1.02	1.0204 (0.00856)	1.021 (0.01015)	1.0159 (0.00605)
Week 4	0.005	-0.0055 (0.00666)	0.0013 (0.00115)	-0.0005 (0.006)

23. Primary Outcome

Title	Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1
Description	Urine samples were collected to assess change from baseline in pH of urine.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	6.5	7	6 (1.173)	5.33 (0.289)	6.16 (0.826)
Week 4	-0.5	0.5 (0.707)	-0.33 (0.289)	-0.24 (0.918)

24. Primary Outcome

Title	Number of Participants With Abnormal Urinalysis Parameters-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	0	5	3	16
Dip stick test for Glucose	0 0%	1 100%	0 0%	2 66.7%
Dip stick test for Protein	0 0%	1 100%	0 0%	6 200%
Dip stick test for Occult Blood	1 100%	2 200%	1 20%	5 166.7%
Dip stick test for Ketones	0 0%	4 400%	0 0%	3 100%

25. Primary Outcome

Title	Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1
Description	Blood samples were collected to assess change from Baseline in TSH.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at specified time points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	0.79	1.22	1.856 (1.6061)	1.463 (1.2079)	2.211 (1.7527)
Week 4	-0.87

26. Primary Outcome

Title	Change From Baseline in Free Triiodothyronine (T3)-Part 1
Description	Blood samples were collected to assess change from Baseline in free T3.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at specified time points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	3.5	3.6	2.75 (0.212)	4.47	3.88 (0.665)

27. Primary Outcome

Title	Change From Baseline in Free Thyroxine (T4)-Part 1
Description	Blood samples were collected to assess change from baseline in free T4.
Time Frame	Baseline (Day 1) and Week 4

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at specified time points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Baseline (Day 1)	10	11	12.43 (3.128)	13.84 (2.296)	15.98 (3.144)
Week 4	2.57

28. Primary Outcome

Title	Overall Survival-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

29. Secondary Outcome

Title	Overall Response Rate-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Number (95% Confidence Interval) [Percentage of Participants]	0 0%	0 0%	0 0%	0 0%	6.3 39.4%

30. Secondary Outcome

Title	Overall Response Rate-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

31. Secondary Outcome

Title	Disease Control Rate-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Number (95% Confidence Interval) [Percentage of Participants]	0 0%	0 0%	0 0%	33.3 1110%	12.5 78.1%

32. Secondary Outcome

Title	Disease Control Rate-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

33. Secondary Outcome

Title	Progression Free Survival-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

34. Secondary Outcome

Title	Time to Response-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

35. Secondary Outcome

Title	Duration of Response-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

36. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Population includes all participants from the All Treated population for whom at least one PK sample was obtained, analysed and measurable.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter]	2758	5965	2686.6 (25.7)	28340.9 (12.3)	6098.3 (25.3)

37. Secondary Outcome

Title	Cmax of Tremelimumab-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	0	16
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter]	0	0	112312.1 (8.2)	93206.7 (24.8)

38. Secondary Outcome

Title	Cmax of Feladilimab-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

39. Secondary Outcome

Title	Cmax of Tremelimumab-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

40. Secondary Outcome

Title	Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	0	5	3	16
Geometric Mean (Geometric Coefficient of Variation) [nanograms/ milliliter]	462	348 (14.2)	3197 (31)	856.4 (35.9)

41. Secondary Outcome

Title	Cmin of Tremelimumab-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	0	5	3	16
Geometric Mean (Geometric Coefficient of Variation) [nanograms/ milliliter]	6467	22466.3 (58.4)	5715.6 (43.9)	15084.9 (48.4)

42. Secondary Outcome

Title	Cmin of Feladilimab-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

43. Secondary Outcome

Title	Cmin of Tremelimumab-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

44. Secondary Outcome

Title	Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population. Only those participants with data available at specified time points has been analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	0	5	3	16
Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours/milliLiter]	545097.4	453561.5 (11.7)	4552653.1 (18.5)	1055659.5 (23.5)

45. Secondary Outcome

Title	AUC(0-t) of Tremelimumab-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population. Only those participants with data available at specified time points has been analyzed.

Arm/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	0	0	0	0	9
Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours/milliLiter]	18160725.7 (23.4)

46. Secondary Outcome

Title	AUC(0-t) of Feladilimab-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

47. Secondary Outcome

Title	AUC(0-t) of Tremelimumab-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

48. Secondary Outcome

Title	Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1
Description	Serum samples were collected and tested for the presence of antibodies to feladilimab.
Time Frame	Pre-dose at Week 4, 7, 10 and 13

Outcome Measure Data

Analysis Population Description

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/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Week 4	0 0%	0 0%	1 20%	0 0%	5 31.3%
Week 7	0 0%	0 0%	1 20%	0 0%	2 12.5%
Week 10	0 0%	0 0%	1 20%	0 0%	1 6.3%
Week 13	0 0%	0 0%	0 0%	0 0%	1 6.3%

49. Secondary Outcome

Title	Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	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
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	1	1	5	3	16
Week 1	0 0%	0 0%	0 0%	0 0%	0 0%
Week 4	0 0%	0 0%	0 0%	1 33.3%	2 12.5%
Week 7	0 0%	1 100%	0 0%	0 0%	1 6.3%
Week 10	0 0%	1 100%	0 0%	0 0%	0 0%
Week 13	0 0%	0 0%	0 0%	0 0%	0 0%

50. Secondary Outcome

Title	Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 2
Description	Serum samples will be collected and tested for the presence of antibodies to feladilimab.
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

51. Secondary Outcome

Title	Change From Baseline in Free T4-Part 2
Description	Blood samples will be collected to assess change from baseline in free T4.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

52. Secondary Outcome

Title	Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 2
Description	Serum samples will be collected and tested for the presence of antibodies to tremelimumab.
Time Frame	Up to 2.5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

53. Secondary Outcome

Title	Number of Participants With AEs, SAEs and AESI-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

54. Secondary Outcome

Title	Number of Participants With AEs, SAEs, AESIs Based on Severity-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

55. Secondary Outcome

Title	Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

56. Secondary Outcome

Title	Change From Baseline in SBP and DBP-Part 2
Description	SBP and DBP will be measured after 5 minutes of rest for the participant.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

57. Secondary Outcome

Title	Change From Baseline in Temperature-Part 2
Description	Temperature will be measured after 5 minutes of rest for the participant.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

58. Secondary Outcome

Title	Change From Baseline in Pulse Rate-Part 2
Description	Pulse rate will be measured after 5 minutes of rest for the participant.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

59. Secondary Outcome

Title	Change From Baseline in Respiratory Rate-Part 2
Description	Respiratory rate will be measured after 5 minutes of rest for the participant.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

60. Secondary Outcome

Title	Change From Baseline in Oxygen Saturation-Part 2
Description	Oxygen saturation will be measured using pulse oximetry after 5 minutes of rest for the participant.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

61. Secondary Outcome

Title	Change From Baseline in ECG Measurement-Part 2
Description	Single 12-lead ECG will be obtained using an automated ECG machine.
Time Frame	Baseline (Pre-dose) up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

62. Secondary Outcome

Title	Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

63. Secondary Outcome

Title	Change From Baseline in Hemoglobin Level-Part 2
Description	Blood samples will be collected to assess change from baseline in hemoglobin level.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

64. Secondary Outcome

Title	Change From Baseline in Hematocrit Level-Part 2
Description	Blood samples will be collected to assess change from baseline in hematocrit level.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

65. Secondary Outcome

Title	Change From Baseline in Erythrocytes Count-Part 2
Description	Blood samples will be collected to assess change from Baseline in erythrocytes count.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

66. Secondary Outcome

Title	Change From Baseline in Albumin and Total Protein Levels-Part 2
Description	Blood samples will be collected to assess change from baseline in albumin and total protein levels.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

67. Secondary Outcome

Title	Change From Baseline in Creatinine and Bilirubin Levels-Part 2
Description	Blood samples will be collected to assess change from baseline in creatinine and bilirubin levels.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

68. Secondary Outcome

Title	Change From Baseline in ALT, AST, ALP, LDH Levels-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

69. Secondary Outcome

Title	Change From Baseline in Amylase and Lipase Levels-Part 2
Description	Blood samples were collected to assess change from baseline in amylase and lipase levels.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

70. Secondary Outcome

Title	Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels -Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

71. Secondary Outcome

Title	Change From Baseline in Specific Gravity of Urine-Part 2
Description	Urine samples will be collected to assess change from Baseline in specific gravity of urine.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

72. Secondary Outcome

Title	Change From Baseline in pH of Urine-Part 2
Description	Urine samples will be collected to assess change from baseline in pH of urine.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

73. Secondary Outcome

Title	Number of Participants With Abnormal Urinalysis Parameters-Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

74. Secondary Outcome

Title	Change From Baseline in TSH-Part 2
Description	Blood samples will be collected to assess change from Baseline in TSH.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

75. Secondary Outcome

Title	Change From Baseline in Free T3-Part 2
Description	Blood samples will be collected to assess change from baseline in free T3.
Time Frame	Baseline and up to 2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Part 2: Feladilimab + Tremelimumab	Part 2: Standard of Care (SOC)
Arm/Group Description	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.	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.
Measure Participants	0	0

Adverse Events

Time Frame	Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years
Adverse Event Reporting Description	All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. 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 in the same.
Arm/Group Title	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		Part 2: Feladilimab + Tremelimumab		Part 2: Standard of Care (SOC)
Arm/Group Description	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.		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.		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.		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.		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.		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.		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.
All Cause Mortality
	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		Part 2: Feladilimab + Tremelimumab		Part 2: Standard of Care (SOC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/5 (0%)		0/3 (0%)		1/16 (6.3%)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	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		Part 2: Feladilimab + Tremelimumab		Part 2: Standard of Care (SOC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		3/5 (60%)		3/3 (100%)		6/16 (37.5%)		0/0 (NaN)		0/0 (NaN)
Cardiac disorders
Cardiac tamponade	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Gastrointestinal disorders
Colitis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Diarrhoea	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
General disorders
Death	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Infections and infestations
Abscess neck	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Bacteraemia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Pneumonia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Investigations
Blood creatinine increased	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Metabolism and nutrition disorders
Dehydration	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Hyponatraemia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Musculoskeletal and connective tissue disorders
Bone pain	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Nervous system disorders
Hydrocephalus	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Renal and urinary disorders
Acute kidney injury	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Chronic kidney disease	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Urinary tract obstruction	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Epistaxis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Hypoxia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Vascular disorders
Embolism	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Hypotension	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Other (Not Including Serious) Adverse Events
	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		Part 2: Feladilimab + Tremelimumab		Part 2: Standard of Care (SOC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/1 (100%)		1/1 (100%)		5/5 (100%)		3/3 (100%)		16/16 (100%)		0/0 (NaN)		0/0 (NaN)
Blood and lymphatic system disorders
Anaemia	0/1 (0%)	0	0/1 (0%)	0	2/5 (40%)	3	1/3 (33.3%)	1	5/16 (31.3%)	5	0/0 (NaN)	0	0/0 (NaN)	0
Cardiac disorders
Atrial flutter	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Sinus bradycardia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Sinus tachycardia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Tachycardia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Endocrine disorders
Hypothyroidism	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Eye disorders
Conjunctival haemorrhage	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Visual impairment	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Gastrointestinal disorders
Abdominal discomfort	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Abdominal distension	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Abdominal pain	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	4/16 (25%)	4	0/0 (NaN)	0	0/0 (NaN)	0
Colitis	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Constipation	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	3/16 (18.8%)	3	0/0 (NaN)	0	0/0 (NaN)	0
Diarrhoea	1/1 (100%)	1	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	8/16 (50%)	11	0/0 (NaN)	0	0/0 (NaN)	0
Dyspepsia	1/1 (100%)	1	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Flatulence	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Gastrooesophageal reflux disease	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Haemorrhoids	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Hyperchlorhydria	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Ileus	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Nausea	1/1 (100%)	1	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	6/16 (37.5%)	7	0/0 (NaN)	0	0/0 (NaN)	0
Oesophagitis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Salivary duct inflammation	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Stomatitis	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	2	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Swollen tongue	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Vomiting	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	2	0/3 (0%)	0	4/16 (25%)	7	0/0 (NaN)	0	0/0 (NaN)	0
General disorders
Asthenia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Chest pain	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Chills	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	2	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Fatigue	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	2	10/16 (62.5%)	10	0/0 (NaN)	0	0/0 (NaN)	0
Malaise	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Non-cardiac chest pain	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Oedema peripheral	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	3/16 (18.8%)	3	0/0 (NaN)	0	0/0 (NaN)	0
Pain	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Physical deconditioning	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Pyrexia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Hepatobiliary disorders
Hepatitis	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Infections and infestations
Bacterial infection	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Bronchitis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Catheter site infection	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Eye infection	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Fungal infection	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Infection	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Oesophageal candidiasis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Oral candidiasis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Oral herpes	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Pyelonephritis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Rash pustular	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Sinusitis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Urinary tract infection	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Injury, poisoning and procedural complications
Procedural pain	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Investigations
Activated partial thromboplastin time prolonged	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Alanine aminotransferase increased	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Aspartate aminotransferase increased	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	3/16 (18.8%)	4	0/0 (NaN)	0	0/0 (NaN)	0
Blood alkaline phosphatase increased	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Blood creatinine increased	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Blood lactate dehydrogenase increased	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Blood thyroid stimulating hormone increased	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
International normalised ratio increased	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Lymphocyte count decreased	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Platelet count decreased	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Weight decreased	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Metabolism and nutrition disorders
Acidosis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Decreased appetite	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	6/16 (37.5%)	7	0/0 (NaN)	0	0/0 (NaN)	0
Dehydration	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Hypercalcaemia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Hyperglycaemia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Hyperkalaemia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Hypoalbuminaemia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	1/3 (33.3%)	1	5/16 (31.3%)	5	0/0 (NaN)	0	0/0 (NaN)	0
Hypocalcaemia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Hypoglycaemia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	3	0/0 (NaN)	0	0/0 (NaN)	0
Hypokalaemia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	2/16 (12.5%)	3	0/0 (NaN)	0	0/0 (NaN)	0
Hypomagnesaemia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Hyponatraemia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	2	1/3 (33.3%)	1	4/16 (25%)	4	0/0 (NaN)	0	0/0 (NaN)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Back pain	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Muscular weakness	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Musculoskeletal chest pain	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Pain in extremity	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	1/1 (100%)	1	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Nervous system disorders
Dizziness	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	3/16 (18.8%)	3	0/0 (NaN)	0	0/0 (NaN)	0
Dysgeusia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Headache	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Neuralgia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Syncope	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Psychiatric disorders
Delirium	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Insomnia	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Restlessness	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Renal and urinary disorders
Acute kidney injury	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Chronic kidney disease	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Reproductive system and breast disorders
Pelvic pain	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Dyspnoea	0/1 (0%)	0	0/1 (0%)	0	2/5 (40%)	2	2/3 (66.7%)	2	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Epistaxis	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Haemothorax	0/1 (0%)	0	1/1 (100%)	1	0/5 (0%)	0	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Hiccups	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Hypoxia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Pleural effusion	0/1 (0%)	0	1/1 (100%)	1	0/5 (0%)	0	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Productive cough	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Skin and subcutaneous tissue disorders
Alopecia	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Dry skin	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Night sweats	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Pruritus	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	1	0/3 (0%)	0	2/16 (12.5%)	2	0/0 (NaN)	0	0/0 (NaN)	0
Rash	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Rash maculo-papular	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Skin irritation	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Vitiligo	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Vascular disorders
Embolism	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	0/3 (0%)	0	1/16 (6.3%)	1	0/0 (NaN)	0	0/0 (NaN)	0
Haematoma	0/1 (0%)	0	0/1 (0%)	0	0/5 (0%)	0	1/3 (33.3%)	1	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0
Hypertension	0/1 (0%)	0	0/1 (0%)	0	1/5 (20%)	2	0/3 (0%)	0	0/16 (0%)	0	0/0 (NaN)	0	0/0 (NaN)	0

Limitations/Caveats

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 in the same.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.