Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Hypopharyngeal Neoplasms
Intervention: Nivolumab; Cisplatin; Docetaxel; Intensity-modulated radiotherapy
Intervention description: Nivolumab is a type of immunotherapy.; Cisplatin is a chemotherapy drug.; Docetaxel is a chemotherapy drug.; IMRT is definitive treatment for head and neck cancer.
Intervention MeSH terms: Docetaxel; Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer

Summary:

      This research is being performed to treat patient for head and neck cancer patients who have
      not received prior chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have histologically or cytologically confirmed, resectable or
             unresectable, Stage III or Stage IV locoregionally advanced squamous cell carcinoma of
             the larynx or hypopharynx, as defined by 2017 American Joint Committee on Cancer
             (AJCC), 8th edition

          -  Willing to provide tissue from diagnostic biopsy and blood samples before, during, and
             after treatment

          -  Any smoking history is permitted

          -  Patients must have HPV negative disease. Those patients with a supraglottic primary
             are required to undergo HPV testing with p16 immunohistochemistry and/or confirmatory
             HPV PCR or ISH testing to rule out oropharyngeal origin with laryngeal extension

          -  Age 18 years or older

          -  ECOG performance status ≤ 1 (Karnofsky ≥ 80%, see Appendix A)

          -  Participant must have normal organ and marrow function as defined below within 21 days
             prior to study registration:

               -  leukocytes ≥3,000/mcL

               -  absolute neutrophil count ≥1,500/mcL

               -  platelets ≥100,000/mcL

               -  total bilirubin ≤2.0 g/dL

               -  AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal

               -  creatinine within normal institutional limits OR

               -  creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels
                  above institutional normal

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of
             contraception. WOCBP should plan to use an adequate method to avoid pregnancy for 5
             months (30 days plus the time required for nivolumab to undergo five half-lives) after
             the last dose of investigational drug

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the
             start of nivolumab

          -  Women of childbearing potential (WOCBP)" is defined as any female who has experienced
             menarche and who has not undergone surgical sterilization (hysterectomy or bilateral
             oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12
             months of amenorrhea in a woman over 45 in the absence of other biological or
             physiological causes. In addition, women under the age of 55 must have a documented
             serum follicle stimulating hormone (FSH) level less than 40 mIU/mL

          -  Men who are sexually active with WOCBP must agree to use any contraceptive method with
             a failure rate of less than 1% per year. Men who are sexually active with WOCBP will
             be instructed to adhere to contraception for a period of 7 months after the last dose
             of investigational product. Women who are not of childbearing potential (ie, who are
             postmenopausal or surgically sterile as well as azoospermic men) do not require
             contraception

        Exclusion Criteria:

          -  Existing severe autoimmune conditions (at the discretion of the treating physician).
             Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone
             therapy are not excluded. Short-term corticosteroid dosing is permitted (i.e.
             dexamethasone for chemotherapy-induced nausea prevention during induction
             chemotherapy) as long as steroids are discontinued within 1 week (7 days) of receiving
             the first dose of nivolumab during the induction phase of treatment.

          -  Subject who has had prior chemotherapy for head and neck cancer and/or radiotherapy to
             the head and neck.

          -  Subject who has been treated with immunotherapy. This includes prior treatment with
             anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug
             specifically targeting T-cell co-stimulation or immune checkpoint pathways.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Known human immunodeficiency virus carrier or a diagnosis of immunodeficiency. Any
             positive test result for hepatitis B virus or hepatitis C virus indicating presence of
             virus, e.g., Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or
             Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).

          -  Known non-infectious pneumonitis or any history of interstitial lung disease.

          -  Has a known additional malignancy that is progressing or requires active treatment.
             Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
             skin that has undergone potentially curative therapy or in situ cervical cancer, and
             low-risk prostate adenocarcinoma being managed with active surveillance. A history of
             another separate malignancy in remission without evidence of active disease in the
             last 5 years is permitted.