RECRUITING

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

Conditions

Head and Neck Cancer Head Cancer Head Cancer Neck Neck Cancer Head and Neck Squamous Cell Carcinoma HNSCC Cemiplimab Platinum-Doublet Chemotherapy Cetuximab Memorial Sloan Kettering Cancer Center 20-445 HNSCC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.

Official Title

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

Quick Facts

Study Start:2021-01-20

Study Completion:2026-06-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04722523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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	* 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. 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

Inclusion Criteria

Exclusion 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.
* 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

* 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.
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

Contacts and Locations

Study Contact

Lara Dunn, MD

CONTACT

646-608-3787

dunnl1@mskcc.org

David Pfister, MD

CONTACT

646-888-4237

pfisterd@MSKCC.ORG

Principal Investigator

Lara Dunn, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-20

Study Completion Date2026-06-20

Study Record Updates

Study Start Date2021-01-20

Study Completion Date2026-06-20

Terms related to this study

Keywords Provided by Researchers

Cemiplimab
Platinum-Doublet Chemotherapy
Cetuximab
Head and Neck Cancer
Head Cancer
Neck Cancer
Head and Neck Squamous Cell Carcinoma
Memorial Sloan Kettering Cancer Center
20-445
HNSCC)

Additional Relevant MeSH Terms

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