Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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
Outcome
Missed primary endpoint
Stopped: “The trial was stopped by the sponsor based on assessment of the clinical data”
registry p = 0.740; Hazard Ratio (HR) 2.16 (95% CI 0.20 to 23.87) NCT04428333 ↗
registry p = 0.284; Hazard Ratio (HR) 0.70 (95% CI 0.20 to 2.43) NCT04428333 ↗
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 | — | — |