The clinical trial is designed to evaluate the effectiveness of adjuvant Cemiplimab versus placebo in patients who have had surgery for high-risk cutaneous squamous cell carcinoma (CSCC). Key Inclusion Criteria include patients aged 21 years or older in Japan, those with a resection of pathologically confirmed CSCC, and individuals who have completed curative intent post-operative radiation therapy within 2 to 10 weeks of randomization. Additionally, participants must have an Eastern Cooperative Oncology Group performance status of 1 or less and adequate hepatic, renal, and bone marrow function.
Key Exclusion Criteria involve patients with squamous cell carcinomas arising in non-cutaneous sites, those with a concurrent malignancy other than localized CSCC, and individuals with a history of malignancy other than localized CSCC within 3 years of randomization. Patients with hematologic malignancies, except for chronic lymphocytic leukemia under specific conditions, and those with a history of distantly metastatic CSCC, unless disease-free for at least 3 years, are also excluded. Furthermore, individuals with significant autoimmune diseases requiring systemic immunosuppressive treatments within the last 5 years are not eligible, except for certain conditions like vitiligo or type 1 diabetes. Prior systemic anti-cancer immunotherapy for CSCC is another exclusion criterion.
This study aims to provide valuable insights into the potential benefits of adjuvant Cemiplimab for patients with high-risk CSCC, focusing on those who meet the stringent inclusion and exclusion criteria outlined in the protocol.
