drugset / Trial / NCT06980038

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

NCT06980038

Phase 2 Recruiting 44 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial compares the effectiveness of cemiplimab with CDX-1140 to cemiplimab without CDX-1140 prior to surgery in treating patients with stage III-IV head and neck cancer. 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. CDX-1140 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving cemiplimab with CDX-1140 versus cemiplimab alone before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed for patients with stage III-IV head and neck cancer.

Timeline

Start
2026-05-27
Primary completion
2027-11-24
Completion
2027-11-24

Drugs

EvaluationDrugModalityDoseRoute
Subject CDX-1140 Monoclonal antibody Intravenous
Subject Cemiplimab Monoclonal antibody Intravenous