FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
← catalyst calendarNCT06788990 · readout ≤ 620 d
Sponsored by Bicara Therapeutics (industry) · BCAX — their whole pipeline →.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
650estimated
Sites
203
Countries
Argentina, Australia, Austria +23
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-28 | actual | When the study began enrolling |
| Primary completion | Apr 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Metastatic Head and Neck Squamous Cell Carcinoma
- Recurrent Head and Neck Squamous Cell Carcinoma
Interventions
- Drug: Ficerafusp alfa
- Drug: Pembrolizumab (KEYTRUDA®)
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFPhase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.
measured 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 Approximately 1 year.
Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.
measured Approximately 2 years.
Phase 3 - Overall Survival (OS)
measured Approximately 3 years.
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