OncoMatch/Clinical Trials/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
Is NCT06980038 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Anti-CD40 Agonist Monoclonal Antibody CDX-1140 and Cemiplimab for head and neck squamous cell carcinoma.
Treatment: Anti-CD40 Agonist Monoclonal Antibody CDX-1140 · Cemiplimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16-negative
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy (cemiplimab)
Any previous treatment with a PD-1 or PD-L1 inhibitor, including cemiplimab (REGN2810)
Lab requirements
Blood counts
Hemoglobin (Hb) ≥ 7 g/dL (transfusion allowed); Absolute neutrophil count ≥ 1,000/mcL; Platelets ≥ 100,000/mcL
Kidney function
Creatinine ≤ 1.5 × institutional ULN OR GFR ≥ 60 mL/min/1.73 m^2
Liver function
Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); AST/ALT ≤ 3 × institutional ULN
Cardiac function
NYHA class II or better if history of cardiac disease or cardiotoxic agents
Hemoglobin (Hb) ≥ 7 g/dL (transfusion allowed to bring Hb to this level); Absolute neutrophil count ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); AST/ALT ≤ 3 × institutional ULN; Creatinine ≤ 1.5 × institutional ULN OR GFR ≥ 60 mL/min/1.73 m^2; NYHA class II or better if cardiac history
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- VCU Massey Comprehensive Cancer Center · Richmond, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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