Trial Profile

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 of Trial: Phase III

Latest Information Update: 17 Dec 2025

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At a glance

Drugs Epacadostat (Primary) ; Pembrolizumab (Primary) ; Carboplatin; Cetuximab; Cisplatin; Fluorouracil
Indications Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
Focus Registrational; Therapeutic Use
Acronyms ECHO-304; KEYNOTE-669
Sponsors Incyte Corporation

03 Dec 2025 Status changed from active, no longer recruiting to completed.
15 Jan 2025 Planned End Date changed from 27 Dec 2024 to 19 Dec 2025.
25 Jul 2024 PFS, OS, and duration of response were removed as endpoints and evaluation of objective response rate (ORR) became the primary objective.

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