Clinical trial NCT03342352: Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: Squamous cell carcinoma of the head and neck
programmed cell death protein 1 (PD-1) antibody
indoleamine 2,3-dioxygenase (IDO) inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 squamous cell carcinoma of the head and neck (SCCHN) when compared to the standard of care (EXTREME regimen).


Eligibility 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.

Primary outcomes:
measure: Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
timeFrame: Up to approximately 35 months
measure: Overall survival (OS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
timeFrame: Up to approximately 48 months
Secondary outcomes:
measure: Objective response rate (ORR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
timeFrame: Up to approximately 35 months
measure: Duration of response (DOR) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) and the EXTREME regimen (Arm B)
timeFrame: Up to approximately 35 months
measure: ORR with nivolumab plus placebo in combination with chemotherapy (Arm C)
timeFrame: Up to approximately 35 months
measure: PFS with nivolumab plus placebo in combination with chemotherapy (Arm C)
timeFrame: Up to approximately 35 months
measure: DOR with nivolumab plus placebo in combination with chemotherapy (Arm C)
timeFrame: Up to approximately 35 months
measure: Time to meaningful symptomatic deterioration (TTSD) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B)
timeFrame: Up to approximately 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb Research and Development
name: Vinny Hayreh, MD
role: STUDY_DIRECTOR
References: