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

Incyte

Status and phase: Withdrawn; Phase 3

Conditions: Head and Neck Cancer

Treatments: Drug: Cetuximab; Drug: Placebo; Drug: Epacadostat; Drug: Cisplatin; Drug: Carboplatin; Drug: Nivolumab; Drug: 5-Fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT03342352

CA2099NA/ECHO-310

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Arm A

Experimental group

Description:

Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.

Treatment:

Drug: 5-Fluorouracil

Drug: Nivolumab

Drug: Carboplatin

Drug: Cisplatin

Drug: Epacadostat

Arm B

Active Comparator group

Description:

EXTREME regimen.

Treatment:

Drug: 5-Fluorouracil

Drug: Carboplatin

Drug: Cisplatin

Drug: Cetuximab

Arm C

Experimental group

Description:

Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.

Treatment:

Drug: 5-Fluorouracil

Drug: Nivolumab

Drug: Carboplatin

Drug: Cisplatin

Drug: Placebo