Actively Recruiting
A Multicenter, Randomized, Double-blind Study of Ficerafusp Alfa BCA101 or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Bicara Therapeutics · Updated on 2026-06-02
650
Participants Needed
173
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma HNSCC. This study focuses on targeting two cancer drivers, EGFR and TGF-, which promote tumor growth and spread. The research is conducted in two phases to identify the best dose and compare treatment outcomes. In Phase 2, participants are randomly assigned to one of three groups high-dose ficerafusp alfa with pembrolizumab, lower-dose ficerafusp alfa with pembrolizumab, or placebo with pembrolizumab. Phase 3 compares the chosen optimal dose of ficerafusp alfa plus pembrolizumab against placebo plus pembrolizumab with a 21 randomization ratio. Treatments are given weekly or every three weeks according to the study arm. Participants will undergo regular evaluations including scans to measure tumor response, safety monitoring for side effects, and quality of life assessments. The study measures outcomes such as tumor response rate, overall survival, progression-free survival, and treatment safety over periods ranging from one to three years. Researchers will also monitor treatment-related adverse events and the impact on symptoms and pain throughout the study.
CONDITIONS
Brief Title
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Histologically or cytologically confirmed recurrent or metastatic Head and Neck Squamous Cell Carcinoma
- Eligible primary tumor locations: oral cavity, hypopharynx, larynx, or oropharynx with documented HPV-negative disease for oropharyngeal squamous cell carcinoma
- No prior systemic therapy for recurrent or metastatic disease; completed systemic therapy more than 6 months prior if given as part of multimodal treatment for locoregionally advanced disease
- Archival tumor tissue available or willing to undergo pretreatment biopsy if needed
- PD-L1 Combined Positive Score (CPS) of 1 or higher
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as defined in the study protocol
You will not qualify if you...
- Disease suitable for local treatment with curative intent
- Prior treatment with anti-TGF-beta therapy
- Prior therapy with anti-EGFR antibodies except for radiosensitizing agents or multimodal locoregional treatment
- History of Grade 2 or higher intolerance or hypersensitivity to anti-EGFR therapy or murine proteins
- Prior immune checkpoint inhibitor therapy within 6 months before study treatment
- Progressive disease less than 6 months after curative systemic therapy for locoregionally advanced disease
- Life expectancy less than 3 months
- Known active central nervous system metastases or history of spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- Active major bleeding or recent major bleeding episode within 4 weeks prior to enrollment
- Participation in another clinical study or investigational drug treatment within 5 half-lives or 4 weeks prior to study
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Chronic active hepatitis B without suppressive antiviral therapy prior to study treatment
- Known hepatitis C infection without completed curative treatment or detectable viral load at screening
- Known history of HIV infection
- Receipt of any organ transplantation requiring immunosuppression except some exceptions
- Additional malignancies within 2 years prior to randomization except certain curatively treated skin and cervical or breast cancers, and low-risk prostate cancer
- Requirement for systemic corticosteroids or immunosuppressive treatment within 7 days prior to first dose except certain topical or local steroids
- Use of live or live attenuated vaccines within 4 weeks prior to screening
Research Team
M
Medical Affairs
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