Regeneron R2810-ONC-1788

Official Title

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)

Study Purpose

To determine if cemiplimab will prevent CSCC from returning after surgery and radiation. The researchers also want to find out if cemiplimab will help people live longer, how study participation affects how people feel, and side effects that people may experience during the study.

Diagnosis

Eligibility

Must have a pathology report that confirms the diagnoses of primary CSCC or primary CSCC with lymph nodes involved, or CSCC that has spread to other parts of the body.

Must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

• A screening period of up to 28 days.
• A treatment period of approximately 48 weeks. By a process called randomization, participants will receive either the cemiplimab or placebo.  A placebo looks like the study drug but contains no drug.
• An end of treatment visit, about 30 days after the completion of the treatment period.

A post-treatment follow-up period of approximately 5 years or until your skin cancer returns or the study ends.

Part 2 of the study is available to participants if the cancer comes back. There is no placebo involved in part 2.