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.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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