Under the leadership of Vishal A. Patel, MD, FAAD, FACMS, director of the Cutaneous Oncology Program at the George Washington University (GW) Cancer Center, the GW Cancer Center was selected as the first global site for a clinical trial for patients with high-risk cutaneous squamous cell carcinoma. The study, sponsored by Regeneron in collaboration with Sanofi, will compare disease-free survival of patients treated with adjuvant cemiplimab, versus those treated with placebo after surgery and radiation therapy.
"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," said Patel, who will lead the study.
The 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 available at the GW Cancer Center, is estimated to enroll over 400 participants worldwide.
"Our participation in this trial represents an important achievement for the GW Cancer Center," said Eduardo M. Sotomayor, MD, Dr. Cyrus Katzen Family Director of the GW Cancer Center and professor of medicine at the GW School of Medicine and Health Sciences. "Being selected as the first site for this study solidifies our increasing reputation as innovators in clinical research and demonstrates our ongoing commitment to investigating potentially promising therapies for patients."
Cemiplimab was approved by the U.S. Food and Drug Administration in September 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.
"By combining innovative immunotherapies with standard treatments, like surgery and radiation, we are hoping to see improved outcomes for patients with cutaneous squamous cell carcinoma," said Mitchell Smith, MD, PhD, associate center director for clinical investigations at the GW Cancer Center. "By conducting this trial, we hope to understand whether this approach can help the patient's own immune system control the skin cancer and keep it from coming back."
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.
The Cutaneous Oncology Program at the GW Cancer Center brings together dermatologists; dermatologic surgeons; medical, surgical, and radiation oncologists; and dermato-pathologists to provide comprehensive and personalized skin cancer care to patients. The program also houses the Supportive Oncodermatology and Cutaneous T-Cell Lymphoma multidisciplinary clinics.
The potential use of cemiplimab in adjuvant CSCC is investigational, and its safety and efficacy have not been evaluated by any regulatory authority for this use.