Clinical Trials | Neoadjuvant Chemotherapy with or without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Sinonasal Squamous Cell Carcinoma that have a T stage (T3, T4a, and select T4b) primary tumor. The purpose of this study is to compare chemotherapy alone to chemotherapy plus immunotherapy with cemiplimab (REGN2810) before surgery. The addition of cemiplimab (REGN2810) to chemotherapy could stop your cancer from growing or spreading. In this study, you will either get cemiplimab (REGN2810) and chemotherapy for six weeks or you will get chemotherapy alone for six weeks. After that, you will have a scan to see how you responded to the drugs, followed by surgery or chemotherapy and radiation therapy. After you finish your study treatment, your doctor will continue to follow your condition for 5 years. You will have a scan every 3-6 months for 2 years after treatment. After that you will have a scan every 12 months for a further 3 years. Your doctor will check your general health and take blood each time you come into the clinic. If you choose to take part in this study, there is a risk that adding cemiplimab (REGN2810) to chemotherapy before surgery may not be better than chemotherapy alone at stopping your cancer from growing or spreading. There is also a risk that you could have side effects from the study drugs. These side effects may be different than you would get with the chemotherapy alone approach for your cancer. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. Additional information found here: Study Details | NCT07281417 | Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma | ClinicalTrials.gov For questions, contact: [email protected]