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

• Status: Withdrawn
• Trial end date: 2018-04-20
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

• Lead Sponsor: Incyte Corporation
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Carboplatin; Cetuximab; Cisplatin; Fluorouracil; Nivolumab

Criteria

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.