Trials / Terminated
TerminatedNCT04428333
Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Feladilimab | Humanized anti-inducible T cell co-stimulatory receptor (ICOS) immunoglobulin G4 (IgG4) monoclonal antibody (mAb) |
| DRUG | Pembrolizumab | Humanized anti- programmed cell death receptor1 (anti-PD-1) IgG4 mAb |
| DRUG | Placebo | Sterile normal saline |
| DRUG | Platinum based chemotherapy | Cisplatin/carboplatin |
| DRUG | Fluorouracil (5FU) | 5-fluorouracil |
Timeline
- Start date
- 2020-08-12
- Primary completion
- 2021-04-27
- Completion
- 2023-09-19
- First posted
- 2020-06-11
- Last updated
- 2024-10-09
- Results posted
- 2022-05-25
Locations
71 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Poland, Romania, Russia, South Korea, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04428333. Inclusion in this directory is not an endorsement.