Phase 1 Study of Cemiplimab Given Before and After Surgery for High-Risk Cutaneous Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the use of cemiplimab, an immunotherapy drug, before and after surgery in patients with high risk cutaneous squamous cell cancer cSCC. This phase I trial aims to study how well cemiplimab works to help the bodys immune system attack cancer cells and potentially reduce the risk of cancer returning or spreading. The study also explores the immune response in patients treated with cemiplimab and monitors survival and recurrence rates over time. The treatment involves two phases. In the neoadjuvant phase, patients receive cemiplimab intravenously over 30 minutes on day 1 before their planned surgery, repeated every 21 days for up to three cycles if no disease progression or serious side effects occur. In the adjuvant phase, patients receive cemiplimab after completing standard radiation therapy or surgery, also given intravenously every 21 days for up to 18 cycles. After treatment, patients are followed up regularly for up to 10 years to monitor outcomes. Participants will undergo assessments including pathology evaluations to measure the response to cemiplimab, monitoring for local and systemic cancer recurrence, and tracking overall and recurrence-free survival for up to two years. Follow-up visits occur every 12 weeks for two years, then every six months for three years, and finally annually up to 10 years. Safety and immune profiles are also evaluated through tumor tissue and blood analyses throughout the study.

Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer