drugset / Trial / NCT04428333
Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx.
Timeline
- Start
- 2020-08-12
- Primary completion
- 2021-04-27
- Completion
- 2023-09-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Feladilimab | Monoclonal antibody | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |
| Background | fluorouracil | Small molecule | — | — |