Under the leadership of Vishal A. Patel, MD, director of the Cutaneous Oncology Program at the George Washington University (GW) Cancer Center, GW was selected as the first global site of a clinical trial for patients with high-risk cutaneous squamous cell carcinoma.
The study, sponsored by biotechnology company Regeneron in collaboration with multinational pharmaceutical firm Sanofi, will compare disease-free survival of patients treated with adjuvant cemiplimab, versus those treated with placebo after surgery and radiation therapy.
The phase III trial is intended to investigate the drug’s safety and effectiveness in preventing recurrence and metastasis in high-risk cutaneous squamous cell carcinoma.
Cemiplimab was approved by the U.S. Food and Drug Administration in 2018 to treat patients with metastatic cutaneous squamous cell carcinoma, or locally advanced cutaneous squamous cell carcinoma, who are not candidates for curative surgery or curative radiation. The immunotherapy treatment is a fully human, monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and was the first treatment approved and available for advanced cutaneous squamous cell carcinoma in the United States.
