Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma

This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.

NCT Number	NCT07281417
Lead Sponsor	National Cancer Institute (NCI)
Conditions	Sinonasal Squamous Cell Carcinoma, Stage III Sinonasal Cancer AJCC v8, Stage IVA Sinonasal Cancer AJCC v8, Stage IVB Sinonasal Cancer AJCC v8
Enrollment	108 participants
Start Date	2026-11-24
Primary Completion	2030-12-16 (estimated)
Study Completion	2030-12-16 (estimated)
Updated on ClinicalTrials.gov	2026-08-14