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

NCT03342352 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-12-20

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Nivolumab

Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.

DRUG

Epacadostat

Epacadostat administered orally at the protocol-defined dose twice daily.

DRUG

Placebo

Matching placebo for epacadostat administered orally twice daily.

DRUG

Carboplatin

Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.

DRUG

Cisplatin

Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.

DRUG

Cetuximab

Cetuximab administered intravenously at the protocol-defined dose weekly.

DRUG

5-Fluorouracil

5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.

Sponsors & Collaborators

Principal Investigators

  • Vinny Hayreh, MD · Bristol-Myers Squibb Research and Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2018-04-20
Completion
2018-04-20
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03342352 on ClinicalTrials.gov