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0501","Sutton","SM2 5PT",{"type":63,"coordinates":1943},[1944,1945],-0.2,51.35,{"lat":1945,"lon":1944},[1948],{"name":70,"role":50,"phone":71,"phoneExt":38,"email":52},{"type":1950,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100576722","phase-2-fortifi-hn01-a-study-of-ficerafusp-alfa-bca101-or-placebo-in-combination-with-pembrolizumab-in-first-line-pd-l1-pos-r-or-m-hnscc-100576722",false,"NCT06788990","FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC","A Multicenter, Randomized, Double-blind, Phase 2\u002F3 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","Inclusion Criteria:\n\n* Age ≥18 years on the day the Informed Consent Form is signed.\n* 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.\n* 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.\n* Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.\n* PD-L1 CPS ≥1.\n* Measurable disease based on RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function, as defined in the protocol.\n\nExclusion Criteria:\n\n* Disease suitable for local therapy administered with curative intent.\n* Prior treatment with anti-TGFβ therapy.\n* Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).\n* Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.\n* Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.\n* Progressive disease \\\u003C6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC.\n* Life expectancy less than 3 months.\n* Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.\n* Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment.\n* 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.\n* Active autoimmune disease requiring systemic treatment in the past 2 years.\n* 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.\n* 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.\n* Known history of human immunodeficiency virus (HIV).\n* Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.\n* Known to be diagnosed and\u002For 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.\n* 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.\n* Use of a live or live attenuated vaccine within 4 weeks prior to Screening.\n\nOther Inclusion\u002FExclusion criteria may apply as defined in the protocol.","ALL","18 Years",{"count":1962,"type":1963},650,"ESTIMATED","INTERVENTIONAL",[1966,1967],"PHASE2","PHASE3","Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).\n\nThis 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).",[1970,1971],"Metastatic Head and Neck Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma",[1973,35,1974,1975,1976,1977,1978,1979,1980,1981,1982,1983,1984,1985,1986],"Phase 2\u002F3","BCA101","Recurrent Head and Neck Squamous Cell Carcinoma (R HNSCC)","Metastatic Head and Neck Squamous Cell Carcinoma (M HNSCC)","Pembrolizumab","EGFR","TGF-beta","HNSCC","PD-L1+","Head and Neck cancer","Oral Cavity","Oropharynx","Larynx","Hypopharynx","2026-05-29",{"date":1989,"type":1990},"2026-06-02","ACTUAL",{"date":1992,"type":1990},"2025-01-28",{"date":1994,"type":1963},"2029-07",{"name":5,"class":6},173]