Status:
WITHDRAWN
Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)
Lead Sponsor:
Incyte Corporation
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03342352
Start Date
December 15 2017
End Date
April 20 2018
Last Update
December 20 2019
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