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

Completed · Phase 3

Conditions studied: Head and Neck Cancer

In brief

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).

Key facts

Study ID: NCT03358472
Run by: Incyte Corporation
People needed: 89
Starts: 2017-12-01
Expected to finish: 2025-10-30
Last updated by the study team: 2025-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Measurable disease based on RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function per protocol-defined criteria.
Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.
Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen.

You may not qualify if…

Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
Disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
Use of protocol-defined prior/concomitant therapy.
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Active autoimmune disease that has required systemic treatment in past 2 years.
Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
Known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is detected).

Where it is running

UC Davis Comprehensive Cancer Center — Sacramento, California, United States
St. Joseph Heritage Healthcare — Santa Rosa, California, United States
University of Colorado Cancer Center — Aurora, Colorado, United States
Yale Cancer Center — New Haven, Connecticut, United States
Northwest Georgia Oncology Centers PC — Douglasville, Georgia, United States
U of Kansas Cancer Center — Westwood, Kansas, United States
Baptist Health — Louisville, Kentucky, United States
St. Vincent Healthcare Cancer Ctr — Billings, Montana, United States
New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
Oklahoma Cancer Specialists and Research — Tulsa, Oklahoma, United States
Providence Portland Med Center — Portland, Oregon, United States
Huntsman Cancer Institute Univ of Utah — Salt Lake City, Utah, United States
Viginia Mason Med Ctr — Seattle, Washington, United States
Chris OBrien Lifehouse — Camperdown, New South Wales, Australia
Macquarie University Hospital — North Ryde, New South Wales, Australia
Royal Brisbane & Women s Hospital — Herston, Queensland, Australia
Landeskrankenhaus Salzburg — Salzburg, Austria
Allgemeines Krankenhaus der Stadt Wien — Vienna, Austria
Juravinski Cancer Center Hamilton Health Sciences — Hamilton, Ontario, Canada
Princess Margaret Cancer Centre — Toronto, Ontario, Canada
Jewish General Hospital — Montreal, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec — Québec, Quebec, Canada
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz — Miskolc, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet — Szolnok, Hungary
Pacific Cancer Medical Center — Anaheim, California, United States

Full record on ClinicalTrials.gov

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