Immunotherapy drug cemiplimab being evaluated for patients
“Squamous cell carcinoma is one of the most common forms of skin cancer in the United States, affecting more than a million Americans each year,” a Sarasota Memorial Health Care System news release explains.
“While most cases are found and treated at an early stage,” the release points out, “larger and fast-growing lesions have a higher risk of coming back and spreading to the lymph nodes or other parts of the body.
“In search of improved treatment outcomes,” the release says, “Sarasota Memorial’s Kolschowsky Research and Education Institute is part of an international clinical trial enrolling qualified patients with advanced stage squamous cell skin cancer, also called cutaneous squamous cell carcinoma (CSCC),” the release points out. “It is one of the most common types of skin cancer, often found in areas exposed to the sun, such as the head, neck and arms.”
The release further notes, “Treatment typically involves surgery, with radiation or chemotherapy if needed. The Phase III study is evaluating whether adding the immunotherapy drug cemiplimab before surgery results in better outcomes than the current standard of care,” the release adds.
“For people at high risk of the squamous cell carcinoma coming back, additional treatment with monoclonal antibodies, such as cemiplimab, may help lower the chances of the cancer recurring,” said Sarasota Memorial head and neck surgeon Dr. Peter Vosler in the release. He is the principal investigator of the local study and a member of Sarasota Memorial’s Brian D. Jellison Cancer Institute, the release notes.
“Immunotherapy can help the body’s immune system attack the cancer, and the study drug cemiplimab may interfere with the ability of tumor cells to grow and spread,” Vosler explained in the release. “Cemiplimab has been approved by the FDA for the treatment of skin cancer that has spread or that cannot be removed by surgery,” the release says, but it “has not yet been approved for the treatment of skin cancer before surgery. In previous studies,” the release continues, “patients showed a positive response to this treatment approach, demonstrating promise for improving outcomes in patients with squamous cell carcinoma.”
The release points out that an “estimated 420 patients across more than 170 study sites worldwide will be enrolled in the trial. To be eligible, participants must be adults 18 or older with previously untreated or recurrent squamous cell skin cancer who are candidates for surgical resection.”
It adds, “Other criteria and conditions apply.”
For more information or to find out if an individual is eligible to participate in the local study, persons may contact Sarasota Memorial’s research team at 941-917-2225 or send an email to researchinstitute@smh.com.
For information about the international trial, visit https://clinicaltrials.gov/study/NCT06568172.
“Located on the flagship Sarasota Memorial Hospital-Sarasota campus, the Kolschowsky Research and Education Institute serves as a premier hub for medical research and clinical innovation,” the release explains. “With dedicated space for research, clinical innovation and graduate medical education, the Kolschowsky Institute provides a collaborative learning environment for physicians, nurses, researchers and students studying new treatments and mastering the latest tools and techniques in patient care.”
For more information, visit https://www.smh.com/Home/Services/Kolschowsky-Research-and-Education-Institute.