FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Metastatic Head and Neck Squamous Cell Carcinoma · Recurrent Head and Neck Squamous Cell Carcinoma
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 2/3
- Patients
- 650 (planned)
- Started
- Jan 28, 2025
- Main results expected
- Apr 2028
- Fully finished
- Jul 2029
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.
Measured over: Up to 30 days post end of treatment for TEAEs (90 days for SAEs).
Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)
Measured over: Approximately 1 year.
Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.
Measured over: Approximately 2 years.
Phase 3 - Overall Survival (OS)
Measured over: Approximately 3 years.
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT06788990 · record last updated 2026-10-29 · checked 2026-11-09 15:47 UTC