A Phase 2 Window of Opportunity Trial of Neoadjuvant Agonistic Anti-CD40 Antibody CDX-1140 and Cemiplimab (REGN2810) in AJCC Stage III-IV Head and Neck Cancer Patients Prior to Surgery

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 44 participants

Interventions

• BIOLOGICAL: Anti-CD40 Agonist Monoclonal Antibody CDX-1140 — Given IV
• PROCEDURE: Biopsy Procedure — Undergo tumor biopsy
• PROCEDURE: Biospecimen Collection — Undergo blood sample collection
• BIOLOGICAL: Cemiplimab — Given IV
• PROCEDURE: Computed Tomography — Undergo CT scan

Primary Outcomes

• Incidence of adverse events (AE) (From the time of their first treatment with CDX-1140 and/or cemiplimab (REGN2810), up to 2 years after surgical resection)
• Major pathologic response (Up to 2 years after surgical resection)

Secondary Outcomes

• Acute incidence of adverse events (From the time of their first treatment with CDX-1140 and/or cemiplimab (REGN2810), up to 2 years after surgical resection)
• Late incidence of adverse events (From the time of their first treatment with CDX-1140 and/or cemiplimab (REGN2810), up to 2 years after surgical resection)
• Quantitative pathologic response (Up to 2 years after surgical resection)
• Tumor infiltrating immune populations (Up to 2 years after surgical resection)
• Serum cytokines levels (Up to 2 years after surgical resection)

Trial Locations

• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
• VCU Massey Comprehensive Cancer Center, Richmond, Virginia, United States

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