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.
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).
|Eligibility criteria|| |
A patient must meet the following criteria to be eligible for inclusion in the study:
|Study details|| |
This study is a randomized, placebo-controlled, double-blind, multicenter, phase 3 study comparing cemiplimab, versus placebo, as adjuvant treatment for CSCC patients with features associated with high-risk of recurrent disease, who have completed surgery and post-operative RT. The study population comprises CSCC patients with high-risk features on surgical pathology who have completed surgery and post-operative RT.
The study consists of 2 parts:
|Further information|| |
For further information regarding this clinical trial click here.
Bundaberg QLD, Tugun QLD