OncoMatch/Clinical Trials/NCT05929664
Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
Is NCT05929664 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cemiplimab and Fianlimab for locally advanced basal cell carcinoma.
Treatment: Cemiplimab · Fianlimab — A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at least 2 and up to 6 infusions of immunotherapy prior to surgical resection. If patients have progression on neoadjuvant treatment, they may switch to standard of care surgical resection or hedgehog inhibitors prior to surgery. The primary endpoints are objective response rate and disease control rate. Safety and surgical benefit rate (de-escalation of surgery) with preservation of key anatomic structures are secondary endpoints. Correlative endpoints include analysis of pre and post treatment primary tumor and blood samples compared for histology, tumor genetics and immune cell composition.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Exception: allowed if completed >6 months prior
Prior radiation therapy within the past 6 months for this target cancer
Cannot have received: immunotherapy
Any patient with prior immunotherapy or HHI for malignancy treatment
Cannot have received: hedgehog pathway inhibitor
Any patient with prior immunotherapy or HHI for malignancy treatment
Lab requirements
Blood counts
Absolute neutrophil count ≥1500/μl; Platelets ≥100,000/μl; Hemoglobin ≥9 g/dl
Kidney function
GFR ≥ 40 ml/min using Cockcroft-Gault or measured creatinine clearance
Liver function
Bilirubin ≤ 1.5 x ULN (except Gilbert syndrome ≤3 mg/dl); AST and ALT ≤ 2.5 x ULN
Adequate organ function: Absolute neutrophil count 1500/μl or more; Platelets 100,000/μl or more; Hemoglobin 9 g/dl or more; Bilirubin ≤ 1.5 x ULN (except Gilbert syndrome ≤3 mg/dl); AST and ALT ≤ 2.5 x ULN; GFR ≥ 40 ml/min using Cockcroft-Gault or measured creatinine clearance
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami Health System · Miami, Florida
- Thomas Jefferson University Hospital · Philadelphia, Pennsylvania
- Vanderbilt University · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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