NCT03358472

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab administered intravenously every 3 weeks.
DRUG	Epacadostat	Epacadostat administered orally twice daily.
DRUG	Cetuximab	Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.
DRUG	Cisplatin	Cisplatin administered intravenously every 3 weeks for \</= 6 cycles.
DRUG	Carboplatin	Carboplatin administered intravenously every 3 weeks for \</= 6 cycles.
DRUG	5-Fluorouracil	5-Fluorouracil administered intravenously every 3 weeks for \</= 6 cycles.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-07-19
• Completion: 2025-10-30
• First posted: 2017-11-30
• Last updated: 2025-12-03
• Results posted: 2019-09-10

Locations

73 sites across 14 countries: United States, Australia, Austria, Canada, Hungary, Italy, Japan, Poland, Portugal, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study