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A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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Trial Profile

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 Aug 2025

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At a glance

  • Drugs Ficerafusp alfa (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Head and neck cancer; Squamous cell cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms FORTIFI-HN01
  • Sponsors Bicara Therapeutics

Most Recent Events

  • 27 Mar 2025 According to Bicara Therapeutics media release, first patient has been dosed in this trial in Feb 2025.
  • 25 Mar 2025 According to a Bicara Therapeutics media release, data from this study will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, which will be held from April 25-30, 2025 in Chicago, IL.
  • 11 Feb 2025 According to Bicara Therapeutics media release, the results for the primary end-points of overall response rate based on RECIST v1.1 and overall survival in this study will potentially support the filings for both accelerated approval and full approval.

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