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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)

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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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Jan 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

Most Recent Events

  • 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.
  • 25 Jul 2024 Study enrollment was discontinued early as a strategic decision on May 2, 2018, and response assessment was discontinued after first on-study imaging assessment at week 9(Data cut-off was January 17, 2019).

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