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Combining chemotherapy and immunotherapy for head and neck cancer treatment

A Pilot Study of Neoadjuvant Cemiplimab With Platinum-Doublet Chemotherapy, and Cetuximab in Patients With Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma

Phase 1 Interventional Memorial Sloan Kettering Cancer Center · NCT04722523

This study is testing if combining chemotherapy with immunotherapy drugs can help people with head and neck cancer before surgery and possibly reduce the need for radiation therapy afterward.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionsCemiplimab, chemotherapy, radiation, prednisone, cetuximab, immunotherapy
Locations7 sites (Basking Ridge, New Jersey and 6 other locations)
Trial IDNCT04722523 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of combining standard chemotherapy with the immunotherapy drugs cemiplimab and cetuximab in patients with head and neck cancer. The goal is to determine if this combination treatment can be administered before surgery and potentially eliminate the need for standard radiation therapy afterward. Participants must have a confirmed diagnosis of squamous cell carcinoma of the head and neck and be candidates for surgical resection. The study will evaluate the outcomes of this novel treatment approach in a Phase 1 setting.

Who should consider this trial

Good fit: Ideal candidates are individuals with pathologically confirmed squamous cell carcinoma of the head and neck who are surgical candidates and have not received prior radiation or systemic therapy.

Not a fit: Patients with distant metastasis or those who have previously undergone radiation or systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and less invasive option for patients with head and neck cancer.

How similar studies have performed: Other studies have shown promise in combining chemotherapy with immunotherapy for various cancers, suggesting potential success for this approach in head and neck cancer as well.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

  ° Patients with recurrent and multiple primary head and neck cancers that are surgically resectable are eligible if the patient did not receive prior radiation or systemic therapy.
* Disease must be amenable to surgical resection.
* The patient must be a surgical candidate.

  1. Hemoglobin \> 9.0 g/dL
  2. Absolute neutrophil count (ANC) \>1.5 x 10\^9/L
  3. Platelet count \>100 x 10\^9/L
  4. Serum creatinine \<1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) \>30 mL/min
  5. Adequate hepatic function:
* 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 Criteria:

* 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.

Exceptions: Patients with vitiligo, type 1 diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that is resolved, or psoriasis it does not require systemic treatment are permitted.

* 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.

  1. Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection monitoring will be performed per local standards
  2. Patients with HBV (hepatitis B surface antigen positive; HBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months be on the last dose of Cemiplimab.
  3. Patients were HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to successful prior course of anti-HCV therapy) are permitted.
* 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:

  1. Stable use of combined estrogen and progesterone containing hormonal contraception or progesterone and-only hormonal contraception associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening
  2. Intrauterine device; intrauterine hormone-releasing system
  3. Bilateral tubal ligation
  4. Vasectomized partner and/or
  5. Sexual abstinence

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Head and Neck CancerHead CancerHead Cancer NeckNeck CancerHead and Neck Squamous Cell CarcinomaHNSCCCemiplimabPlatinum-Doublet Chemotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.