FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Recruiting

Phase 2

Phase 3

Ficerafusp Alfa & PembrolizumabFORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Sponsor:

Bicara Therapeutics

Code:

NCT06788990

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ficerafusp alfa

Pembrolizumab (KEYTRUDA®)

Placebo

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information

Trial information was received from ClinicalTrials.gov and was last updated on 2025-11-06. This information was provided to ClinicalTrials.gov by Bicara Therapeutics on 2025-11-04.