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
Single group
Cemiplimab
DrugCemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles).
Objective Response Rate (ORR) at six months
ORR@6months, defined as the rate of patients assessed with complete or partial response (CR or PR) according to ERIVANCE-like criteria as best overall response, relative to the total number of patients as evaluated 6 months after treatment allocation.
Objective Response Rate (ORR)
rate of patients assessed with complete or partial response (CR or PR) as best overall response, relative to the total number of patients.
Progression Free Survival (PFS)
time from date of allocation to treatment to the date of the first objectively documented tumor progression, as determined by investigators, or death due to any cause.
Duration of Response (DoR)
length of time from initial response (CR/PR) to first objectively documented progression or death.
Overall Survival (OS)
time from date of allocation to treatment until the date of death from any cause
Determination of molecular biomarkers and their correlation with objective response rate (ORR)
Biosamples will be used for determination of molecular biomarkers and their correlation with objective response rate (ORR) by assessing e.g., gene expression signatures, tumor mutational burden including mutational signatures as well as morphological and cellular characteristics of the tumor microenvironment.
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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
