OncoMatch/Clinical Trials/NCT06981325
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Is NCT06981325 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cemiplimab for basal cell carcinoma (bcc).
Treatment: Cemiplimab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic immunotherapy
Exception: Prior treatment with imiquimod or other topical or intralesional immune modulators will not be exclusionary
Pretreatment with systemic immunotherapy (such as PD-1/PD-L1 or CTL4) or targeted therapy (such as hedgehog inhibitor)
Cannot have received: targeted therapy (hedgehog inhibitor)
Pretreatment with systemic immunotherapy (such as PD-1/PD-L1 or CTL4) or targeted therapy (such as hedgehog inhibitor)
Cannot have received: other non-radiation anti-cancer therapy (imiquimod, photodynamic therapy)
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
Lab requirements
Blood counts
Absolute neutrophils ≥ 1.5 x 10^9/L; Platelets ≥ 75 x 10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
Liver function
Total bilirubin ≤ 1.5x ULN (Gilbert's Disease up to 3x ULN with approval); AST (SGOT) and ALT (SGPT) ≤ 3x ULN; AP ≤ 2.5x ULN
Adequate laboratory parameters particularly for the blood count, renal and liver function parameters. 1. Absolute number of neutrophils ≥ 1.5 x 10^9/L 2. Platelets ≥ 75 x 10^9/L 3. Hemoglobin ≥ 9 g/dL 4. 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) 5. AST (SGOT) and ALT (SGPT) ≤ 3x ULN 6. AP ≤ 2.5x ULN 7. Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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