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) | Biotech Hunter

Timeline

Start Date

December 15, 2017

Primary Completion Date

April 20, 2018

Study Completion Date

April 20, 2018

Conditions

Head and Neck Cancer

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.