Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
44
Participants Needed
6
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed AJCC stage III-IV mucosal head and neck squamous cell carcinoma suitable for surgical removal
- Both untreated and recurrent cancer cases are eligible
- Tumors must be accessible for biopsy
- For oropharyngeal cancer, only p16-negative patients qualify
- Patients must have measurable disease with lesion size as specified
- Age 18 years or older
- ECOG performance status of 0 to 2 (Karnofsky 60% or higher)
- Hemoglobin at least 7 g/dL (transfusion allowed to reach this level)
- Absolute neutrophil count at least 1,000/mcL
- Platelet count at least 100,000/mcL
- Total bilirubin no higher than 1.5 times institutional upper normal limit
- AST/ALT no higher than 3 times institutional upper normal limit
- Creatinine no higher than 1.5 times institutional upper normal limit or GFR at least 60 mL/min/1.73 m2
- HIV-positive patients on effective therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B must have undetectable viral load on suppressive therapy
- Patients with hepatitis C must be treated and cured or have undetectable viral load if on treatment
- Patients with cardiac disease risk must be NYHA class II or better
- Women of childbearing potential and men must use effective contraception during treatment and for 4 months after last dose
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Active or history of autoimmune disease within 2 years before screening
- Prior or planned allogeneic hematopoietic stem cell transplant
- History of organ transplant requiring immunosuppressive medication
- Use of immunosuppressive medication within 14 days before study drug
- Previous treatment with PD-1 or PD-L1 inhibitors including cemiplimab
- Concurrent use of prednisone 10 mg or more
- Presence or history of pneumonitis or interstitial lung disease
- Another active cancer that could interfere with study assessments
- Unrecovered side effects from previous cancer treatments except hair loss
- Use of other investigational agents or cancer therapies during study
- Allergic reactions to drugs similar to CDX-1140 or cemiplimab
- Uncontrolled illness or conditions making participation unsafe
- Pregnant or breastfeeding women due to risks to fetus and infant
AI-Screening
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Trial Site Locations
Total: 6 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
4
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
5
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
6
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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