Actively Recruiting
A Phase 2 Trial of Neoadjuvant Anti-CD40 Antibody CDX-1140 and Cemiplimab in Stage III-IV Head and Neck Cancer Patients Prior to Surgery
Led by National Cancer Institute (NCI) · Updated on 2026-06-01
44
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of combining cemiplimab with CDX-1140 compared to 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, a monoclonal antibody that may help the immune system attack cancer cells, can improve outcomes such as shrinking tumors and reducing the amount of healthy tissue removed. The study also assesses safety, gene expression, tumor environment changes, and biomarkers related to treatment response. 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 standard additional therapy if needed. The other group receives CDX-1140 intravenously on day 1 and cemiplimab on day 4, followed by the same surgery and post-surgery treatments. Both groups undergo CT scans, PET scans, tumor biopsies, and blood sample collections during the study. Treatment continues unless the disease progresses or unacceptable side effects occur. During the study, participants have various evaluations including imaging scans, tumor biopsies, and blood tests to monitor immune responses and tumor changes. Follow-up visits occur at weeks 9-10, 18, 6 months, and then every 3-6 months for up to 2 years after surgery. The main outcomes measured include major pathologic response, adverse events, gene expression, tumor immune cells, circulating tumor DNA, and pharmacokinetics of the drugs used.
CONDITIONS
Brief 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...
- Histologically or cytologically confirmed AJCC stage III-IV mucosal head and neck squamous cell carcinoma suitable for surgery
- Tumors accessible for biopsy in clinic or by endoscopy
- For oropharyngeal cancer, must be p16-negative (non-HPV related)
- Measurable disease with at least one lesion ≥ 20 mm by chest X-ray or ≥ 10 mm by CT, MRI, or clinical exam
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky ≥ 60%)
- Hemoglobin ≥ 7 g/dL (transfusion allowed)
- Absolute neutrophil count ≥ 1,000/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 times institutional upper limit
- AST/ALT ≤ 3 times institutional upper limit
- Creatinine ≤ 1.5 times institutional upper limit or GFR ≥ 60 mL/min/1.73 m²
- HIV-positive patients on effective antiretroviral therapy with undetectable viral load within 6 months
- For chronic hepatitis B, viral load must be undetectable on suppressive therapy if needed
- Patients with hepatitis C must be cured or have undetectable viral load if on treatment
- Cardiac function assessment showing NYHA class II or better
- Women and men of childbearing potential must use effective contraception during treatment and for 4 months after last dose
- Ability to understand and 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 medications
- 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 higher
- New or history of pneumonitis or interstitial lung disease
- Another active cancer interfering with safety or efficacy assessment
- Unresolved adverse effects from prior cancer therapy greater than grade 1 except alopecia
- Use of other investigational agents during the trial
- Allergic reactions to compounds similar to CDX-1140 or cemiplimab
- Uncontrolled illness or conditions that increase risk
- Pregnant or breastfeeding women due to risks to fetus or child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 5 weeks
Participants receive cemiplimab or a combination of CDX-1140 and cemiplimab intravenously before surgery. Treatment is given in the absence of disease progression or unacceptable toxicity.
1 to 2 infusion visits before surgery
Duration - 1 week
Participants undergo standard of care surgical resection of their tumor.
1 surgical visit
Duration - Up to 2 years
Participants receive standard of care adjuvant therapy and have follow-up visits to monitor recovery and outcomes after surgery.
Visits at week 9-10, week 18, at 6 months, and every 3-6 months thereafter for 2 years
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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