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

• Status: Active, not recruiting
• Trial end date: 2022-06-27
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Carboplatin; Cetuximab; Cisplatin; Fluorouracil; Pembrolizumab

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).