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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 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 117 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04428333
The ClinicalTrials.gov registry entry for NCT04428333 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04428333 reports 0 study locations.
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.
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