for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion



The purpose of this study is 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).

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)


Head and Neck CancerHead and neck squamous cell carcinomaprogrammed cell death 1 (PD-1) inhibitorindoleamine 2,3-dioxygenase 1 (IDO1) inhibitorCarcinomaCarcinoma, Squamous CellHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckCisplatinCarboplatinPembrolizumabCetuximabFluorouracilEpacadostat5-Fluorouracil


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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).


  • University of California San Diego Moores Cancer Center
    La JollaCalifornia92093-0698United States
  • UCI- Orange, CA
    OrangeCalifornia92868United States


in progress, not accepting new patients
Start Date
Completion Date
Incyte Corporation
Phase 3
Study Type
Last Updated