Industry sponsors Regeneron and Sanofi have selected George Washington University (GW) Cancer Center as the first global site for a clinical trial for patients with high-risk cutaneous squamous cell carcinoma. The study will compare disease-free survival of patients treated with adjuvant cemiplimab versus those treated with placebo after surgery and radiation therapy.
What is High Risk Cutaneous Squamous Cell Carcinoma
It is an increasingly grave public health concern representing the second most common cancer in the United States. The high-risk cutaneous squamous cell carcinoma represents a subgroup of the disease and patients associated with this condition face higher risk of metastasis and death.
Cutaneous squamous cell carcinoma is the second most common form of skin cancer behind basal cell carcinoma and represents approximately 20% of nonmelanoma skin cancer cases. More than 1 million cases of squamous cell carcinoma are diagnosed in the United States each year, resulting in more than an estimated 7,000 deaths. Current treatment options include surgery, including Mohs micrographic surgery, radiation therapy, and systemic chemotherapy for metastatic disease.
Principal Investigator Comments
Vishal A. Patel, MD, FAAD, FACMS director of the Cutaneous Oncology Program at George Washington University Cancer Center will lead the effort for the first site. Dr. Patel noted “This selection highlights the commitment of the GW Cancer Center to invest in the development of the premier multi-disciplinary cutaneous oncology program in the District of Columbia.”
A randomized, placebo-controlled, double-blind phase III trial is intended to investigate cemiplimab’s safety and effectiveness in preventing recurrence and metastasis in high risk cutaneous squamous cell carcinoma. The study currently only being run at the GW Cancer Center is estimated to enroll over 400 participants worldwide as reported in the press release via Newswise.
Also known as REGN-2810, Cemiplimab is a monoclonal antibody under development as a drug for the treatment of squamous cell skin cancer, myeloma and lung cancer. In September 2018, it was approved by the U.S. FDA for treating “patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.” The drug will be marketed as Libtayo.
Vishal A. Patel, MD, FAAD, FACMS director of the Cutaneous Oncology Program at George Washington University Cancer Center