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A Multicenter, Randomized, Double-blind, Phase 2/3 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 (FORTIFI-HN01)

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

jRCT Inquiry Receipt Center

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo

FORTIFI_inquiries@bicara.com

jRCT Inquiry Receipt Center

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo

+81-3-6859-9500

JP-FORTIFI-HN01_jRCT@iqvia.com

Recruiting

Aug. 31, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.

- Disease suitable for local therapy administered with curative intent.
- Prior treatment with anti-TGF beta therapy.
- Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).
- Prior history of Grade >=2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.
- Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.
-Progressive disease <6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC.
- Life expectancy less than 3 months.
- Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.
- Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment.
- Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy.
- Active autoimmune disease requiring systemic treatment in the past 2 years.
- Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.
- Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening.
- Known history of human immunodeficiency virus (HIV).
- Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.
- Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer.
- Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids.
- Use of a live or live attenuated vaccine within 4 weeks prior to Screening.

Both

Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

[Experimental]
ficerafusp alfa OBD + pembrolizumab 200 mg Q3W

[Placebo Comparator]
placebo QW + pembrolizumab 200 mg Q3W

Dual primary endpoints:

1. Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR. [Time Frame: Approximately 2 years.]
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.

2. Phase 3 - Overall Survival (OS) [Time Frame: Approximately 3 years.]
OS: Defined as the time from the randomization to death due to any cause.

Aug. 05, 2026

No

United States/Argentina/Australia/Austria/Belgium/Brazil/Canada/Czech Republic Czechia/France/Germany/Greece/India/Ireland/Israel/Italy/Malaysia/New Zealand/Poland/Portugal/Singapore/South Korea/Spain/Switzerland/Taiwan/United Kingdom