This Phase I/II trial is evaluating how safe and tolerable the combination of two intravenous immunotherapies (GSK3359609 and tremelimumab) is for patients with select advanced solid cancers (part one), in particular patients that have relapsed or refractory squamous cell carcinoma of the head and neck (part two).
This trial is treating multiple types of cancer including cutaneous melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, urothelial carcinoma, clear cell renal carcinoma or castrate resistant prostate adenocarcinoma.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
- You have previously been treated (or are currently being treated) on a clinical trial.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
A Phase I/II, Open-label, Two Part Study of GSK3359609 in Combination With Tremelimumab in Participants With Selected, Advanced Solid Tumors
Commercial Sponsor
GlaxoSmithKline
Summary
In part one of this trial, participants with select, advanced solid cancers will scalating doses of GSK3359609 and tremelimumab in combination. In part two of the trial, participants with relapsed or refractory squamous cell carcinoma of the head and neck, 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, will be randomised 2:1 to receive 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.
Recruiting Hospitals Read More