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

The present study is an explorative, investigator-initatied, single-arm, multicentre phase II trial. Patients with locally advanced BCC without pretreatment with hedgehog inhibitors such as vismodegib and sonidegib will receive Cemiplimab (350 mg, i.v.) at day 1 of each 21 days cycle for up to 12 months (max. 17 cycles) or until intolerable toxicity or disease progression, whatever occurs first. All patients will be followed up until death or for up to 12 months after last patient last application of Cemiplimab. The treatment response will be assessed every 12 weeks (± 7 days) during the treatment and the follow up phase. In addition, tumor samples will be collected and used for translational research providing the basis for the establishment of potential biomarkers correlating with the efficacy of Cemiplimab. The primary objective of this study is to evaluate the efficacy of Cemiplimab when applied as first-line treatment in advanced, HHI naïve BCC measured by objective response rate (ORR) after 6 months of treatment. Secondary objective is to evaluate the safety and tolerability of Cemiplimab as first-line treatment in advanced BCC.