Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
Condition: Head and Neck Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Pembrolizumab; Epacadostat; Cetuximab; Cisplatin; Carboplatin; 5-Fluorouracil
Intervention description: Pembrolizumab administered intravenously every 3 weeks.; Epacadostat administered orally twice daily.; Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.; Cisplatin administered intravenously every 3 weeks for </= 6 cycles.; Carboplatin administered intravenously every 3 weeks for </= 6 cycles.; 5-Fluorouracil administered intravenously every 3 weeks for </= 6 cycles.
Intervention MeSH terms: Carboplatin; Pembrolizumab; Fluorouracil; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and neck squamous cell carcinoma; programmed cell death 1 (PD-1) inhibitor; indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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).