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NCT04128696 · ClinicalTrials.gov registry record · Phase 3
Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 315
- Enrollment target
NCT04128696 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 315 participants.
The verdict
NCT04128696, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 315 participants
- Enrollment target
Study Summary
The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) \>=1 R/M HNSCC.
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG feladilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2023-06-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04128696
The ClinicalTrials.gov registry entry for NCT04128696 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 315 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 3 interventions - of which Pembrolizumab is the first listed.
NCT04128696 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04128696 about?
NCT04128696 is a clinical study titled "Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase...
What is the current status of trial NCT04128696?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2019-11-21. Estimated completion is 2023-06-20.
What interventions are being tested in trial NCT04128696?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), feladilimab (DRUG).
Who is sponsoring clinical trial NCT04128696?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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