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NCT04428333 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT04428333: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT04428333 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04428333, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study 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.
Primary Outcome
OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier estimate for the median OS is presented, along with associated 95% confidence interval, estimated using the Brookmeyer-Crowley method.
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG Fluorouracil (5FU)
- DRUG Platinum based chemotherapy
- DRUG Feladilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2023-09-19 |
| Phase | Phase 3 |
Why NCT04428333 stopped before completion
NCT04428333 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04428333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04428333 about?
NCT04428333 is a clinical study titled "Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". 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 squ...
What is the current status of trial NCT04428333?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2020-08-12. Estimated completion is 2023-09-19.
What interventions are being tested in trial NCT04428333?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Fluorouracil (5FU) (DRUG), Platinum based chemotherapy (DRUG), Feladilimab (DRUG).
Who is sponsoring clinical trial NCT04428333?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04428333's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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