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FORTIFI-HN01: ficerafusp alfa + pembrolizumab vs placebo + pembrolizumab in PD-L1-positive recurrent/metastatic HNSCC
jRCT2031260394Phase 3Recruiting
- Sponsor
- Bicara Therapeutics
- Start
- Aug 2026
- Modality
- Vaccines & Immunotherapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
01
Overview
Phase 3, randomised, double-blind trial in head and neck squamous cell carcinoma (HNSCC) comparing ficerafusp alfa (BCA101) + pembrolizumab with placebo + pembrolizumab (2 arms). Primary endpoints: Objective Response Rate (ORR) per RECIST 1.1 by BICR and Overall Survival (OS). Started Aug 2026; status: recruiting.
02
Drugs
ficerafusp alfa
03
Conditions
head and neck squamous cell carcinoma (HNSCC)
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