Tests ficerafusp alfa with pembrolizumab as first treatment for head and neck cancer

Trial details

Who runs it

Bicara Therapeutics

Trial code

NCT07807163EU 2026-526741-10-00

Record updated

13 October 2026

Original description

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).Read full original descriptionShow less

A Multicenter, Open-label, Randomized Phase 2 Study Evaluating Continuous Weekly Dosing of Ficerafusp Alfa (BCA101) in Combination With Pembrolizumab Versus an Alternative Ficerafusp Alfa Dosing Regimen for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).

The study aims to demonstrate that the antitumor activity of an alternative dosing regimen of ficerafusp alfa in combination with pembrolizumab is comparable to the weekly ficerafusp alfa regimen in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Inclusion: 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.

Exclusion: Prior treatment with anti-TGFβ therapy; Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation; 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; 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; 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; Disease suitable for local therapy administered with curative intent; Progressive disease <6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC; Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded; Active autoimmune disease requiring systemic treatment in the past 2 years; 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); 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; Life expectancy less than 3 months.

ClinicalTrials.gov NCT07807163 · EU CTIS 2026-526741-10-00