A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC)
Objective
Primary Objective The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT).
Secondary Objectives The secondary objectives of the study are: To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT.
To compare the effect of adjuvant cemiplimab with that of placebo on patients freedom from locoregional recurrence (FFLRR) after surgery and RT.
To compare the effect of adjuvant cemiplimab with that of placebo on patients freedom from distant recurrence (FFDR) after surgery and RT.
To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT.
To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT
