GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors
Status:
Completed
Trial end date:
2021-09-16
Target enrollment:
Participant gender:
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.