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

Phase 3 Completed 89 enrolled Incyte Corporation Merck Sharp & Dohme LLC · collab

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2017-12-01
Primary completion: 2018-07-19
Completion: 2025-10-30

Publications

Cho BC, Brana I, Cirauqui B, Aksoy S, Couture F, Hong RL, Miller WH Jr, Chaves-Conde M, Teixeira M, Leopold L, Munteanu M, Ge JY, Swaby RF, Hughes BGM. Pembrolizumab plus epacadostat in patients with recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTE-669/ECHO-304): a phase 3, randomized, open-label study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1254. doi: 10.1186/s12885-023-11316-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	—	Intravenous
Comparator	Cetuximab	Monoclonal antibody	—	Intravenous
Comparator	Cisplatin	Other / unclassified	—	Intravenous
Subject	Epacadostat	Small molecule	100 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Comparator	fluorouracil	Small molecule	—	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications