CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 89 enrolled
Drug / intervention
Pembrolizumab +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03358472
NCT03358472Phase 3Completed
CompareCT.gov

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)

Incyte Corporation·interventional·Posted Nov 30, 2017·Updated Dec 3, 2025

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Epacadostat, and 4 other interventions for Head and Neck Cancer. Completed, enrolled 89 participants across 73 sites in 14 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesAustralia, Austria, Canada, Hungary, Italy, Japan, Poland, Portugal, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 30, 2017
Enrollment StartDec 1, 2017
Primary CompletionJul 19, 2018
Study CompletionOct 30, 2025
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.6 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab administered intravenously every 3 weeks.

Epacadostatdrug

Epacadostat administered orally twice daily.

Cetuximabdrug

Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.

Cisplatindrug

Cisplatin administered intravenously every 3 weeks for \</= 6 cycles.

Carboplatindrug

Carboplatin administered intravenously every 3 weeks for \</= 6 cycles.

5-Fluorouracildrug

5-Fluorouracil administered intravenously every 3 weeks for \</= 6 cycles.