FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
NCT06788990 · FORTIFI-HN01 Phase 2/3Recruiting
- Lead sponsor
- Bicara Therapeutics (Industry)
- Enrollment
- 650 (estimated)
- Start date
- 28 Jan 2025
- Primary completion
- Apr 2028 (estimated)
- Study completion
- 1 Jul 2029
- Last update posted
- 29 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Double
- Arms
- 5
Interventions
- Ficerafusp alfa Drug
- Pembrolizumab (KEYTRUDA®) Drug
- Placebo Drug
Conditions and primary outcome
- Metastatic Head and Neck Squamous Cell Carcinoma
- Recurrent Head and Neck Squamous Cell Carcinoma
Primary outcome
Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation. (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) (Approximately 1 year.); Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR. (Approximately 2 years.); Phase 3 - Overall Survival (OS) (Approximately 3 years.)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06788990.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06788990 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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