Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
Public ClinicalTrials.gov record NCT03358472. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03358472
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Drug
- Epacadostat Drug
- Cetuximab Drug
- Cisplatin Drug
- Carboplatin Drug
- 5-Fluorouracil Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2017 (Actual)
- Primary completion
- Jul 19, 2018 (Actual)
- Completion
- Oct 30, 2025 (Actual)
- Last update posted
- Sep 29, 2026
2017 – 2025
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pacific Cancer Medical Center | Anaheim | California | 19026 | — |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Northwest Georgia Oncology Centers PC | Douglasville | Georgia | 30134 | — |
| U of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Baptist Health | Louisville | Kentucky | 40223 | — |
| St. Vincent Healthcare Cancer Ctr | Billings | Montana | 59102 | — |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87106 | — |
| Oklahoma Cancer Specialists and Research | Tulsa | Oklahoma | 74146 | — |
| Providence Portland Med Center | Portland | Oregon | 97213 | — |
| Huntsman Cancer Institute Univ of Utah | Salt Lake City | Utah | 19026 | — |
| Viginia Mason Med Ctr | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03358472, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03358472 live on ClinicalTrials.gov.