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

Sponsor
Incyte Corporation
Study ID
NCT03342352
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
  • Epacadostat — DRUG
    Epacadostat administered orally at the protocol-defined dose twice daily.
  • Placebo — DRUG
    Matching placebo for epacadostat administered orally twice daily.
  • Carboplatin — DRUG
    Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
  • Cisplatin — DRUG
    Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
  • Cetuximab — DRUG
    Cetuximab administered intravenously at the protocol-defined dose weekly.
  • 5-Fluorouracil — DRUG
    5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.

Study Details

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).

Key Dates

Start date
Dec 15, 2017
Status verified
Dec 2019
Primary completion
Apr 20, 2018
Completion
Apr 20, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Nivolumab plus epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.
  • Active Comparator: Arm B
    EXTREME regimen.
  • Experimental: Arm C
    Nivolumab plus placebo for epacadostat in combination with platinum (carboplatin/cisplatin) plus 5-fluorouracil.

Primary Outcome Measure

Progression-free survival (PFS) with nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to the EXTREME regimen (Arm B) [ Time Frame: Up to approximately 35 months ]

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