ClinicaliQ Trial Snapshot
- 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 II • Oncology • NCT06788990.
- What is being tested: Ficerafusp alfa (a dual EGFR/TGF-β targeted therapy) combined with pembrolizumab versus pembrolizumab alone as first-line treatment for PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
- Patient eligibility overview: Adults with PD-L1-positive, recurrent or metastatic HNSCC who are treatment-Phase IIïve for advanced disease and suitable for immunotherapy-based combinations.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
Eligibility Snapshot
- : * Age ≥18 years on the day the Informed Consent Form is signed. * Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with documented HPV-negative disease if presenting with OPSCC). Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded. * No prior systemic therapy administered in the R or M setting; and completed systemic therapy >6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting. * Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable. * PD-L1 CPS ≥1. * Measurable disease based on RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function, as defined in the protocol.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.