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FORTIFI-HN01: ficerafusp alfa plus pembrolizumab vs placebo plus pembrolizumab in first-line PD-L1-positive recurrent/metastatic head and neck squamous cell carcinoma
2024-519654-37-00Phase 3Authorised
- Sponsor
- Bicara Therapeutics
- Start
- Nov 2025
- Modality
- Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Countries
- 27
01
Overview
Phase 3, randomised, double-blind trial in head and neck squamous cell carcinoma (HNSCC) comparing ficerafusp alfa + pembrolizumab with placebo + pembrolizumab (2 arms). Primary endpoints: Safety, Tolerability and 2 more. Planned start Nov 2025; status: authorised.
02
Drugs
ficerafusp alfapembrolizumab
03
Conditions
head and neck squamous cell carcinoma (HNSCC)
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