# Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

Source: https://onco.cc/trials/nct03358472/  
OnCo record `nct03358472` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Pembrolizumab, Epacadostat, Cetuximab, Cisplatin and Carboplatin in Head and neck squamous cell carcinoma, run by Incyte Corporation, completed.

## Summary

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304) is a phase 3 interventional study registered as NCT03358472 by Incyte Corporation, with 89 participants recorded, started 2017-12-01 and reaching its primary completion in 2018-07-19. Interventions recorded: Pembrolizumab, Epacadostat, Cetuximab, Cisplatin, Carboplatin, 5-Fluorouracil. Conditions recorded: Head and Neck Cancer.

Linked to the drug Epacadostat because the registry names it among its interventions and Head and neck squamous cell carcinoma among its conditions. Registry record only: no result has been read by an editor.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03358472
- Phase: 3
- Setting: 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)
- Sponsor: Incyte Corporation
- Enrolled: 89

## Sources

- ClinicalTrials.gov NCT03358472: https://clinicaltrials.gov/study/NCT03358472

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cetuximab](https://onco.cc/drugs/cetuximab/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Epacadostat](https://onco.cc/drugs/epacadostat/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Incyte](https://onco.cc/companies/incyte/)

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