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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: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03040999 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 804 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
EFS was defined as the time from date of randomization to the date of first record of any of the following events: death due to any cause; progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR) or biopsy as indicated for locoregional progression or recurrence or distant metastasis. As well as the first record of the following types of surgery: salvage surgery for persistent or residual disease at the primary tumor site r
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 |
What the finished NCT03040999 record still lists
NCT03040999 is an interventional study that assigns participants to a tested intervention. The registered 804 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03040999 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03040999's enrollment target sits among peer trials
804 412th of 2000 higher than 1,588 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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