Clinical Trials /

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

NCT04722523

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 20-445
  • NCT ID: NCT04722523

Conditions

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

Interventions

DrugSynonymsArms
CisplatinHead and Neck Squamous Cell Cancer/HNSCC
CarboplatinHead and Neck Squamous Cell Cancer/HNSCC
DocetaxelHead and Neck Squamous Cell Cancer/HNSCC
CetuximabHead and Neck Squamous Cell Cancer/HNSCC
CemiplimabHead and Neck Squamous Cell Cancer/HNSCC

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Head and Neck Squamous Cell Cancer/HNSCCExperimentalParticipants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible.
  • Cisplatin
  • Carboplatin
  • Docetaxel
  • Cetuximab
  • Cemiplimab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of toxicities graded according to NCI CTCAE
Time Frame:1 year
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • 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)

Last Updated

January 28, 2021