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NCT03040999 · ClinicalTrials.gov registry record · Phase 3
Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 804
- Enrollment target
NCT03040999 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 804 participants.
The verdict
NCT03040999, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 804 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- DRUG Cisplatin
- RADIATION Accelerated Fractionation (AFX) Radiotherapy
- RADIATION Standard Fractionation (SFX) Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 804 participants |
| Start Date | 2017-04-05 |
| Est. Completion | 2024-08-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03040999
The ClinicalTrials.gov registry entry for NCT03040999 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 804 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03040999 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03040999 about?
NCT03040999 is a clinical study titled "Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)". The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that p...
What is the current status of trial NCT03040999?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 804 participants. The study started on 2017-04-05. Estimated completion is 2024-08-21.
What interventions are being tested in trial NCT03040999?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Cisplatin (DRUG), Accelerated Fractionation (AFX) Radiotherapy (RADIATION), Standard Fractionation (SFX) Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT03040999?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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