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NCT03358472 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
A Phase 3 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT03358472: Completed Phase 3 study, sponsored by Incyte Corporation.
NCT03358472 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 89 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03358472, a Phase 3 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Primary Outcome
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination. Responses are based on investigator assessments per RECIST 1.1 without confirmation using all available scans.
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Epacadostat
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2025-10-30 |
| Phase | Phase 3 |
What the finished NCT03358472 record still lists
NCT03358472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03358472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03358472 about?
NCT03358472 is a clinical study titled "Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)". The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (H...
What is the current status of trial NCT03358472?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2017-12-01. Estimated completion is 2025-10-30.
What interventions are being tested in trial NCT03358472?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Epacadostat (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT03358472?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03358472's enrollment target sits among peer trials
89 1738th of 2000 higher than 262 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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