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.
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Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1
Timeframe: Up to 28 days
Number of Participants With DLTs According to Severity-Part 1
Timeframe: Up to 28 days
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1
Timeframe: Up to 4 years
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1
Timeframe: Up to 4 years
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1
Timeframe: Up to 4 years
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1
Timeframe: Up to 4 years
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Temperature-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Pulse Rate-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Respiratory Rate-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Oxygen Saturation-Part 1
Timeframe: Baseline (Day 1) and Week 4
Number of Participants With Electrocardiogram (ECG) Findings
Timeframe: Baseline (Pre dose, Day 1) and up to 4 Years
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Hemoglobin Level-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Hematocrit Level-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Erythrocytes Count-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Albumin and Total Protein Levels-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Creatinine and Bilirubin Levels-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Amylase and Lipase Levels-Part 1
Timeframe: Baseline (Day 1) and week 4
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Specific Gravity of Urine-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1
Timeframe: Baseline (Day 1) and Week 4
Number of Participants With Abnormal Urinalysis Parameters-Part 1
Timeframe: Week 4
Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Free Triiodothyronine (T3)-Part 1
Timeframe: Baseline (Day 1) and Week 4
Change From Baseline in Free Thyroxine (T4)-Part 1
Timeframe: Baseline (Day 1) and Week 4
Overall Survival-Part 2
Timeframe: Up to 4 years