CEMIPLIMAB for Basal cell carcinoma | Advanced basal cell carcinoma

Inclusion criteria

• {"criterion_text":"- 1. Signed informed consent form available.\n- 10. Negative serum pregnancy test done less than or equal to 7 days prior to enrollment, for females of childbearing potential only.\n- 11. 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\n- 2. Patient* 18 years or older at time of signing informed consent form. * There are no data that indicate special gender distribution. *Therefore, patients will be enrolled in the study gender-independently\n- 3. 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 (5µm 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)\n- 4. 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)\n- 5. Expected survival of at least 6 months\n- 6. ECOG performance status 0 or 1\n- 7. Adequate laboratory parameters particularly for the blood count, renal and liver function parameters. a) Absolute number of neutrophils ≥ 1.5 x 109/L b) Platelets ≥ 75 x 109/L c) Hemoglobin ≥ 9 g/dL d) 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) e) AST (SGOT) and ALT (SGPT) ≤ 3x ULN f) AP ≤ 2.5x ULN g) Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min\n- 8. Absence of other severe comorbidities\n- 9. 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."}

Exclusion criteria

• {"criterion_text":"- 1. 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\n- 10. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n- 11. Receipt of live vaccines (including attenuated) within 30 days of first administration of Cemiplimab\n- 12. Pregnancy or lactation period.\n- 13. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.\n- 14. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results\n- 15. Legal incapacity or limited legal capacity.\n- 16. On-treatment participation in another clinical trial in the period 30 days prior to start of the study treatment and during the study\n- 2. 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\n- 3. 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\n- 4. 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\n- 5. Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of Cemiplimab. NOTE: Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are eligible for participation. Furthermore, patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or replacement in case of adrenal or hypophysis insufficiency are eligible for participation.\n- 6. Known allergic/hypersensitive reaction to the study drug and any of its excipients or history of documented allergic/hypersensitive reactions to antibody treatments\n- 7. Active infection requiring systemic therapy, including uncontrolled HIV, HBV and HCV infection or diagnosis of immunodeficiency. NOTE: Patients are eligible if: - Patients have controlled HIV infection with CD4 counts is > 350 cells/µL and viral load is undectable [HIV RNA PCR] - Patients positive for HBV surface antigen have controlled HBV infection receiving anti-viral therapy and with undectable serum viral load [HBV DNA PCR]. Patients must remin on anti-viral therapy for at least 6 months after last dose of Cemiplimab - Patients positive for HCV antibody have controlled HCV infection with undectable viral load [HCV RNA PCR]\n- 8. History of pneumonitis within the last 3 years\n- 9. Patients with history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the Lead Investigator)"}

Primary endpoints

• {"endpoint_text":"- ORR@6months is 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.","definition_or_measurement_approach":"Rate of patients assessed with complete or partial response (CR or PR) according to ERIVANCE-like criteria as best overall response, evaluated 6 months after treatment allocation."}

Secondary endpoints

• {"endpoint_text":"- ORR is defined as the rate of patients assessed with complete or partial response (CR or PR) as best overall response, relative to the total number of patients.","definition_or_measurement_approach":"Rate of patients with CR or PR as best overall response relative to total number of patients."}
• {"endpoint_text":"- PFS is defined as 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.","definition_or_measurement_approach":"Time from allocation to treatment until first objectively documented tumor progression or death (investigator-determined)."}
• {"endpoint_text":"- DoR is defined as length of time from initial response (CR/PR) to first objectively documented progression or death.","definition_or_measurement_approach":"Duration from initial CR/PR to first documented progression or death."}
• {"endpoint_text":"- OS defined as time from date of allocation to treatment until the date of death from any cause.","definition_or_measurement_approach":"Time from allocation to treatment until death from any cause."}
• {"endpoint_text":"- Time to next systemic treatment is defined as time from date of allocation to treatment to initiation of the next line of systemic therapy.","definition_or_measurement_approach":"Time from allocation to treatment until start of next systemic therapy."}
• {"endpoint_text":"- Incidence of adverse events and serious adverse events","definition_or_measurement_approach":"Count and rate of adverse events and serious adverse events reported during the study period."}
• {"endpoint_text":"- Severity of adverse events by CTCAE v5.0 grade","definition_or_measurement_approach":"Adverse event severity graded using CTCAE v5.0."}
• {"endpoint_text":"- Relationship of adverse events to Cemiplimab","definition_or_measurement_approach":"Assessment of causal relationship between adverse events and Cemiplimab as judged by investigators."}
• {"endpoint_text":"- Incidence of adverse events and serious adverse events","definition_or_measurement_approach":"Count and rate of adverse events and serious adverse events (duplicate endpoint entry)."}
• {"endpoint_text":"- Severity of adverse events by CTCAE v5.0 grade","definition_or_measurement_approach":"Adverse event severity graded using CTCAE v5.0 (duplicate endpoint entry)."}
• {"endpoint_text":"- Relationship of adverse events to Cemiplimab","definition_or_measurement_approach":"Assessment of causal relationship between adverse events and Cemiplimab as judged by investigators (duplicate entry)."}
• {"endpoint_text":"- Tissue samples may be used for the following analyses: - Morphology (H&E and trichrome/connective tissue stain) - Multiplexed immunofluoresence with panels addressing T-cell activation and differentiation as well as the immunomodulating tumor microenvironment - Transcriptomics (EdgeSeq-based mRNA expression) - Infered tumor mutational burden (TMB) - TCR repertoire. Blood samples will be used for TCR repertoire analysis at the central biomarker laboratory.","definition_or_measurement_approach":"Exploratory biomarker analyses on tissue (morphology, multiplex immunofluorescence, transcriptomics, inferred TMB, TCR repertoire) and blood for TCR repertoire at central lab."}

Germany

Earliest CTIS Part Ii Submission Date

03-02-2025

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

396

Number Of Sites

7

Number Of Participants

34

Primary sponsor

Full Name

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Medicoline Pharma Solutions KG","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Translational Skin Cancer Research - University Duisburg-Essen","duties_or_roles":"Central Pathological Evaluation","organisation_type":"Health care"}