CEMIPLIMAB for Cutaneous squamous cell carcinoma | Resectable high-risk stage III/IV (M0) cutaneous squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- Patients of either sex aged ≥18 years."}
• {"criterion_text":"- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form."}
• {"criterion_text":"- Patients must have histologically or cytologically surgically resectable, high risk stage III/IV (M0) cutaneous squamous cell carcinoma. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at Multidisciplinary Tumor Conference attended by CSCC medical and surgical oncology staff. Resectable tumors are defined as having no significant vascular, neural or bony involvement."}
• {"criterion_text":"- Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team."}
• {"criterion_text":"- Patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0-1"}
• {"criterion_text":"- Patients must have organ and marrow function as defined below: absolute neutrophil count (ANC) ≥1.5 X 10^9/L; hemoglobin ≥9-5 g/dL; platelets ≥100 X 10^9/L; prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤1.5 X upper limit of normal (ULN); total bilirubin ≤1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN ^1; albumin ≥2.5 g/dL; creatinine ≥1.5 X ULN 2 OR calculated creatinine clearance ≥50 mL/min OR 24-hour urine creatinine clearance ≥50 mL/min"}
• {"criterion_text":"- Female subjects of childbearing potential must have a negative pregnancy test result at baseline and must practice a reliable method of contraception for the total study duration plus 6 months after the last dose of cemiplimab"}
• {"criterion_text":"- Men who are sexually active with women of childbearing potential must practice a reliable method of contraception for the total study duration plus 6 months after the last dose of cemiplimab"}

Exclusion criteria

• {"criterion_text":"- Evidence of metastatic disease extra limphnodal"}
• {"criterion_text":"- Currently or previous cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug"}
• {"criterion_text":"- Prior malignancy within the prior 5 years, except for the following: in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years"}
• {"criterion_text":"- Any major surgery within the last 3 weeks"}
• {"criterion_text":"- Unwillingness or inability to follow the procedures required in the protocol"}
• {"criterion_text":"- Uncontrolled diabetes, hypertension, pneumonitis and abnormal thyroid function or other medical conditions that may interfere with assessment of toxicity"}
• {"criterion_text":"- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment"}
• {"criterion_text":"- Female subjects who are pregnant (positive pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control"}

Primary endpoints

• {"endpoint_text":"- major pathological response rate (<10% remaining viable tumour cells in resected primary tumor).","definition_or_measurement_approach":"As stated: major pathological response defined as <10% remaining viable tumour cells in resected primary tumor."}
• {"endpoint_text":"- Recurrence-free survival (RFS - the time from start of treatment until disease recurrence (local, regional or distant) or death from any cause)","definition_or_measurement_approach":"RFS defined as the time from start of treatment until disease recurrence (local, regional or distant) or death from any cause."}
• {"endpoint_text":"- Overall Survival (OS - the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive)","definition_or_measurement_approach":"OS defined as the length of time from either the date of diagnosis or the start of treatment that patients are still alive."}
• {"endpoint_text":"- Safety","definition_or_measurement_approach":"No specific measurement approach provided in the record beyond the general endpoint label 'Safety'."}
• {"endpoint_text":"- To determine molecular and immunophenotypic changes in tumor and peripheral blood evaluating several biomarkers. Since the identification of new markers for immunotherapy is rapidly evolving, the definitive list of analyses remains to be determined","definition_or_measurement_approach":"Evaluation of molecular and immunophenotypic changes in tumor and peripheral blood; specific biomarkers and assays not definitively listed in the record."}

Italy

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

12-09-2025

Processing Time Days

312

Number Of Sites

6

Number Of Participants

25

Primary sponsor

Full Name

Fondazione Melanoma Onlus

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Italy