Dysautonomia International

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

Purpose

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).

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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 (by PD-L1 IHC 22C3 pharmDx assay). - 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 Criteria

Disease suitable for local therapy administered with curative intent. - Prior treatment with anti-TGFβ 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. Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)