Phase 2 Trial of Cemiplimab With or Without CDX-1140 Before Surgery in Patients with Stage III-IV Head and Neck Cancer

What this Trial Is About

Researchers are evaluating the combination of cemiplimab with CDX-1140 versus cemiplimab alone before surgery in patients with stage III-IV head and neck cancer. This phase II trial aims to see if adding CDX-1140, an antibody that may block tumor growth, improves treatment response. The study also examines safety, gene expression, immune response, and potential biomarkers related to treatment effects in this cancer type. Participants are randomly assigned to one of two groups. One group receives cemiplimab intravenously on day 1, followed by surgery between days 29 and 36 and then standard additional therapy. The other group receives CDX-1140 intravenously on day 1 and cemiplimab on day 4, followed by the same surgery and further therapy schedule. Both groups are monitored with CT and PET scans, tumor biopsies, and blood samples throughout the study. Throughout the trial, participants undergo regular assessments including imaging, biopsies, and blood tests to track tumor and immune changes. After treatment completion, follow-up visits occur at weeks 9-10, 18, six months, and then every 3 to 6 months for up to two years post-surgery. The study measures outcomes such as adverse events, pathologic response, tumor DNA levels, and immune system markers to understand treatment impact and safety over time.

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer