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)

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Head and Neck Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-15
• Primary completion: 2018-04-20
• Completion: 2018-04-20
• First posted: 2017-11-14
• Last updated: 2019-12-20

Regulatory

• FDA-regulated drug study