Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (CEMI-first) - An Open Label, Single Arm, Prospective Phase II Trial of the DeCOG Network
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
• NOTE: Tumor tissue to be sent to Central Pathology during screening procedure:
⁃ Formalin-fixed, parrafin-embedded (FFPE) tumor specimen in a paraffin block (preferred) OR
⁃ approximately 10 sections (5µm thickness) on uncoated slides and 10 sections (3µm thickness) on Superfrost Ultra slides containing unstained, freshly cut, serial sections to be submitted along with associated pathology report (please refer to section 11.1.1 for details)
• Locally advanced stage without distant metastases, not amenable for surgery or radiotherapy or surgery/radiotherapy contraindicated or refused by patient (as evidenced in source data)
• Expected survival of at least 6 months
• ECOG performance status 0 or 1
• Adequate laboratory parameters particularly for the blood count, renal and liver function parameters.
∙ Absolute number of neutrophils ≥ 1.5 x 109/L
‣ Platelets ≥ 75 x 109/L
‣ Hemoglobin ≥ 9 g/dL
‣ Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), (patients with Gilbert´s Disease and total bilirubin up to 3x ULN may be eligible after approval from trial's medical expert)
‣ AST (SGOT) and ALT (SGPT) ≤ 3x ULN
‣ AP ≤ 2.5x ULN
‣ Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
• Absence of other severe comorbidities
• Resolution of any acute, clinically significant treatment-related adverse events from prior therapy/procedure to Grade ≤ 1 prior to study entry, with the exception of alopecia.
⁃ Negative serum pregnancy test done less than or equal to 7 days prior to enrollment, for females of childbearing potential only.
⁃ Sexually active women of childbearing potential (WOCBP) and men with WOCBP partners must be prepared to use suitable contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 6 months after the last dose of Cemiplimab
∙ There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently