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A Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab

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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

  • Sex: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase I
  • Conditions Being Studied:

Study Purpose

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Principal Investigator
Matthew Mirsky MD
Department/Division
Cancer (Head and Neck)
  • UH IRB: STUDY20250473
  • StudyID: BCTP1324
  • ClinicalTrials.gov: NCT06788990
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1-800-641-2422

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