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

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:December 15, 2017
End Date:January 2023
Contact:Incyte Corporation Call Center (US)

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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.
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Anniston, Alabama 36207
Anniston, AL
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Denver, Colorado 80210
Denver, CO
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