Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)
NCT ID: NCT03342352
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-12-15
2018-04-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
Epacadostat
Epacadostat administered orally at the protocol-defined dose twice daily.
Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
Arm B
EXTREME regimen.
Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cetuximab
Cetuximab administered intravenously at the protocol-defined dose weekly.
5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
Arm C
Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
Placebo
Matching placebo for epacadostat administered orally twice daily.
Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
Interventions
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Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
Epacadostat
Epacadostat administered orally at the protocol-defined dose twice daily.
Placebo
Matching placebo for epacadostat administered orally twice daily.
Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
Cetuximab
Cetuximab administered intravenously at the protocol-defined dose weekly.
5-Fluorouracil
5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Untreated central nervous system (CNS) metastases.
* Carcinomatous meningitis.
* Active, known or suspected autoimmune disease.
* Physical and laboratory test findings outside the protocol-defined range.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Vinny Hayreh, MD
Role: STUDY_DIRECTOR
Bristol-Myers Squibb Research and Development
Countries
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Other Identifiers
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CA2099NA/ECHO-310
Identifier Type: -
Identifier Source: org_study_id