Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)

A Randomized, Global, Phase 3 Trial of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Platinum + 5-fluorouracil) Versus the EXTREME Regimen (Cetuximab + Platinum + 5-fluorouracil) in First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) / CheckMate 9NA /ECHO-310

The purpose of this study is to evaluate the safety and efficacy of the combination of nivolumab plus epacadostat in combination with chemotherapy in first-line recurrent or metastatic patients with squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen).

Inclusion Criteria:

• Histologically confirmed SCCHN from any of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx.
• Must have recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy).
• No prior treatment with systemic anti-cancer therapy for SCCHN unless protocol-defined conditions are met.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
• Documentation of program death ligand-1 (PD-L1) status prior to randomization.

Exclusion Criteria:

• Recurrent or metastatic carcinoma of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma) and SCCHN of unknown primary origin.
• Untreated central nervous system (CNS) metastases.
• Carcinomatous meningitis.
• Active, known or suspected autoimmune disease.
• Physical and laboratory test findings outside the protocol-defined range.