Phase II Study of Cemiplimab as First Treatment for Locally Advanced Basal Cell Carcinoma Not Previously Treated with Hedgehog Inhibitors

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Cemiplimab as a first-line treatment for patients with locally advanced basal cell carcinoma BCC who have not previously received hedgehog inhibitor therapy. This phase II, open-label, single-arm trial aims to measure the objective response rate after six months of treatment in this patient group. Patients with advanced BCC who cannot undergo surgery or radiotherapy are included to explore new treatment options. Participants will receive Cemiplimab intravenously at a dose of 350 mg on day 1 of every 21-day cycle for up to 12 months or a maximum of 17 cycles. Treatment may stop earlier if intolerable side effects or disease progression occurs. Tumor samples will be collected for research to identify potential biomarkers that may relate to the drugs effectiveness. The study also includes follow-up visits every 12 weeks to monitor response and safety until death or for up to 12 months after the last dose. Throughout the study, patients will have regular assessments including tumor response evaluations every 12 weeks during treatment and follow-up. Researchers will monitor safety by tracking adverse events and laboratory parameters. The main outcome measured is the objective response rate at six months, with additional measures such as progression-free survival and overall survival tracked for up to 42 months. Participants are followed closely to understand both the benefits and risks of Cemiplimab in this setting.

Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients