FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC (FORTIFI-HN01)
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
Sponsor: Bicara Therapeutics
Listed as NCT06788990, this PHASE2/PHASE3 trial focuses on Metastatic Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma and remains actively recruiting participants. Sponsored by Bicara Therapeutics, it has been updated 13 times since 2025, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
13 versions recorded-
Mar 2026 — Present [monthly]
Recruiting PHASE2/PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE2/PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE2/PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE2/PHASE3
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE2/PHASE3
▶ Show 8 earlier versions
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE2/PHASE3
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE2/PHASE3
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE2/PHASE3
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Jun 2025 — Aug 2025 [monthly]
Recruiting PHASE2/PHASE3
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE2/PHASE3
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE2/PHASE3
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE2/PHASE3
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Feb 2025 — Mar 2025 [monthly]
Recruiting PHASE2/PHASE3
First recorded
Jan 2025
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bicara Therapeutics
For direct contact, visit the study record on ClinicalTrials.gov .