Back to search results

Cemiplimab with Chemotherapy and Immunotherapy for Head and Neck Cancer

This study is looking at people with head and neck squamous cell carcinoma. It's testing if combining standard chemotherapy (cisplatin, carboplatin, or docetaxel) with two immunotherapy drugs, cetuximab and cemiplimab, is safe. The study also wants to see if this combination treatment, given before surgery, could help you avoid radiation treatment after surgery. You could join if you have a confirmed diagnosis of squamous cell carcinoma of the head and neck and meet specific staging criteria. The main goal is to track any side effects (toxicities) for one year. The current status of this study is unclear, and it plans to enroll about 40 participants.

Study design
This interventional study plans to enroll about 40 participants. It is testing a combination of chemotherapy and immunotherapy drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the incidence of toxicities for one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04722523

A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~40 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:CisplatinCarboplatinDocetaxelCetuximabCemiplimabSurgical Resection of Primary +/- Neck Dissection

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of toxicities graded according to NCI CTCAE
Measured over 1 year

Conditions

Head and Neck Cancer
Head Cancer
Head Cancer Neck
Neck Cancer
Head and Neck Squamous Cell Carcinoma
HNSCC

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Lara Dunn, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Lara Dunn, MD
[email protected]
646-608-3787
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx
Clinical stage T1, N2-3; T2, N1-3, T3/T4a, Any N (AJCC, 8th ed.) without evidence of distant metastasis (M0) based on PET/CT or CT chest, abdomen, and pelvis, for which standard-of-care treatment would entail surgical resection with adjuvant radiation +/- chemotherapy.
Disease must be amenable to surgical resection.
The patient must be a surgical candidate.
Total bilirubin \<1.5 x upper limit of normal ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both \< 3 x ULN
Alkaline phosphatase (ALP) \<2.5 x ULN Note: For patients with Gilbert syndrome, total bilirubin \<3x ULN. Upper central must be documented appropriately as past medical history.
Men and woman \>18 years old
Eastern cooperative oncology group performance status \< 1

Exclusion

Prior radiation and systemic therapy for a head and neck cancer.
Oral cavity cancer that is not amenable to surgical resection or the patient is not a surgical candidate.
Active or prior documented autoimmune or inflammatory disorders that have been treated with steroids or immunomodulator therapy in the past 5 years.
Conditions requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressant medications within 14 days of treatment on study.
Receipt of live attenuated vaccine within 30 days prior initiating treatment on study.
Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.
Any infection requiring hospitalization and/or intravenous antibiotic therapy within 2 weeks of the start of treatment.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency.
History of immune-related pneumonitis with the last 5 years.
History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of leuko-corticoids to assist with management.
Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.
Patients with a history of solid organ transplant (exception: corneal transplant)
Any medical comorbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that in the opinion of the investigator renders the patient unsuitable for participation in a clinical trial due to high safety risks.
Women with a positive serum or urine beta-hCG pregnancy test at screening/baseline visit. If positive, pregnancy must be ruled out by ultrasound for patient to be eligible.
Breast-feeding women
Women of childbearing potential who are sexually active and aren't willing to practice highly effective contraception prior to the first dose of Cemiplimab, during the study, and for at least 180 days after the last dose. Highly effective contraceptive measures include:

What this trial measures

  • Incidence of toxicities graded according to NCI CTCAE1 year

    The primary endpoint is safety and tolerability, which will be evaluated by a description of observed adverse events by grades. All toxicities will be graded according to NCI CTCAE, Version5.0. The regimen will be deemed safe and well tolerated if there are 2 or fewer DLTs out of 10 patients enrolled. A DLT is defined as any non-hematologic grade 3 or greater adverse event as defined by CTCAE v5.0 that is thought to be related to the addition of Cemiplimab to the combination of a platinum-doublet with cetuximab.