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).
To be considered for the study you must meet the following criteria:
- Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease
- High risk CSCC
- Completion of curative intent post-operative RT within 2 to 6 weeks of randomization
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:
- Part 1 (blinded): A screening period of up to 28 days prior to randomization, a treatment period of up to 48 weeks, and a follow-up period. Patients will undergo post-treatment follow-up until disease recurrence or end of study. Part 1 of the study supports the primary endpoint.
- Part 2 (unblinded): Optional cemiplimab treatment for patients on the placebo arm who experience disease recurrence and optional subsequent treatment with cemiplimab for patients on the cemiplimab arm who experience disease recurrence ≥3 months after completing 48 weeks of planned cemiplimab treatment. Patients may be treated for up to 96 weeks.