The study is an open-label, singel arm, prospective, multicenter phase II trial evaluating the efficacy and safety of Cemiplimab when applied as first-line therapy in patients with locally advanced basal cell carcinoma (BCC), which were not pretreated with hedgehog inhibitors (HHI).
Signed informed consent form available
Patient* 18 years or older at time of signing informed consent form
Centrally confirmed histological diagnosis of BCC
Formalin-fixed, parrafin-embedded (FFPE) tumor specimen in a paraffin block (preferred) OR
Pretreatment with systemic immunotherapy (such as PD-1/PD-L1 or CTL4) or targeted therapy (such as hedgehog inhibitor) NOTE: Prior treatment with imiquimod or other topical or intralesional immune modulators will not be exclusionary
Any other non-radiation anti-cancer therapy (e.g. imiquimod, photodynamic therapy; neither investigational nor standard of care) within 30 days (from date of last administration) of initial Cemiplimab administration or if planned during the study duration
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required systemic immunosuppressive therapy, excluding: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment
Other neoplasia, in particular hematologic diseases that might impair immune response, such as chronic lymphocytic leukemia, myelodysplastic or myeloproliferative disease and patients with Gorlin-Goltz syndrom
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Skin Cancer Center Minden, Department of Dermatology, Johannes-Wesling-Klinikum Minden
Collaborator
Universität Duisburg-Essen
Collaborator
Regeneron Pharmaceuticals
Collaborator