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

NCT03358472 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-12-03

Study results available
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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).

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab administered intravenously every 3 weeks.

DRUG

Epacadostat

Epacadostat administered orally twice daily.

DRUG

Cetuximab

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

DRUG

Cisplatin

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

DRUG

Carboplatin

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

DRUG

5-Fluorouracil

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

Sponsors & Collaborators

Principal Investigators

  • Mark Jones, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-07-19
Completion
2025-10-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Hungary
  • Italy
  • Japan
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03358472 on ClinicalTrials.gov