HPV Vaccine with or without Pembrolizumab for Human Papilloma Virus-related Cancer of the Head and Neck

Overview

About this study

Some patients with head and neck cancer caused by human papilloma virus have a higher risk of recurrence. We are proposing to treat these patients with HPV vaccine with or without pembrolizumab during the window prior to surgery, in hopes of stimulating an immune response.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Registration – Inclusion Criteria

  • Age ≥ 18 years.
  • Disease characteristics.
  • Locally advanced HPV-OPSCC and high-risk HPV-specific testing with at least one of the following:
    • Radiology ENE; OR
    • cN2 disease or (contralateral/bilateral nodes); OR
    • cN3 disease (LN > 6 cm); OR
    • Radiographic evidence of 4 or more involved lymph nodes.
  • Candidate for surgical resection.
  • Measurable or unmeasurable disease as defined by RECIST 1.1 criteria.
  • Adequate organ function as defined below ≤15 days prior to registration:
    • White blood cell (WBC) count ≥ 3,000/mm^3;
    • Platelet count ≥ 75,000/mm^3;
    • Hemoglobin ≥ 9.0 g/dL (5.6mmol/L);
      • NOTE: Transfusions are not allowed ≤ 7 days prior to registration.
    • Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (or total bilirubin ≤ 3.0 X ULN with direct bilirubin ≤ 1.5 X ULN in patients with well-documented Gilbert’s Syndrome);
    • Aspartate transaminase (AST/SGOT) ≤ 2.5 X ULN;
    • Creatinine ≤ 1.5 mg/dL (133 µmol/L); OR
    • Calculated creatinine clearance ≥ 30mL/min/1.73m^2 for patients with creatinine levels above ULN.
    • Cockcroft-Gault Equation:
    • Creatinine clearance for males =    (140 - age)(weight in kg)
    •                                                         ( 72)(serum creatinine in mg/dL)
    • Creatinine clearance for females =  (140 - age)(weight in kg)(0.85)
    •                                                          ( 72)(serum creatinine in mg/dL)
    • PT/INR/PTT ≤1.5 X ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of anticoagulants.
    • Negative pregnancy test done ≤3 days prior to registration, for persons of childbearing potential only.
    • Persons of childbearing potential or able to father a child must be willing to use an adequate method of birth control for the course of the study through 120 days after the last dose of study medication.
      • NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred method of contraception for the patient.
    • Provide written informed consent.
    • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
    • Willingness to provide mandatory blood specimens for correlative research.
    • Willingness to provide mandatory tissue specimens for correlative research.

Exclusion Criteria - Registration:

  • Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
  • NOTE: Exceptions are allowed for:
    • Vitiligo;
    • Resolved childhood asthma/atopy;
    • Intermittent use of bronchodilators or inhaled steroids;
    • Daily steroids at dose of ≤10mg of prednisone (or equivalent);
    • Local steroid injections;
    • Stable hypothyroidism on replacement therapy;
    • Stable diabetes mellitus;
    • Sjögren’s syndrome.
  • Any prior head or neck radiotherapy.
  • Any of the following prior therapies:
    • Live vaccine < 30 days prior to registration, including intranasal flu vaccine (e.g. Flu-Mist®);
    • Note: Injected seasonal influenza vaccine is not “live”);
    • Chemotherapy or targeted small molecule therapy < 21 days prior to registration;
    • Investigational therapy or investigational device < 14 days prior to registration.
  • Current or prior use of immunosuppressive medication < 14 days prior to registration.
  • The following are exceptions to this criterion:
    • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intraarticular injection);
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent;
    • Steroids as premedication for hypersensitivity reactions (e.g., premedication for CT scans).
  • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection requiring systemic therapy;
    • Interstitial lung disease;
    • Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn’s disease or others);
    • Known active hepatitis B (i.e., known positive HBV surface antigen (HBsAg) reactive);
    • Known active hepatitis C (i.e., positive for HCV RNA detected by PCR);
    • Known active tuberculosis (TB);
    • Symptomatic congestive heart failure;
    • Unstable angina pectoris;
    • Unstable cardiac arrhythmia; or
    • Psychiatric illness/social situations that would limit compliance with study requirements (e.g., substance abuse).
  • History of allogeneic hematopoietic transplant or any solid organ transplant.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Other active malignancy < 2 years prior to registration.
    • EXCEPTIONS: Non-melanotic skin cancer (SCC/BCC), micropapillary thyroid cancer, Gleason 6 prostate cancer, carcinoma-in-situ of the breast or cervix.
  • Any of the following conditions ≤ 6 weeks prior to registration:
    • Cerebrovascular accident (CVA);
    • Admission for unstable angina;
    • Cardiac angioplasty or stenting or coronary artery bypass graft surgery;
    • Untreated pulmonary embolism or untreated deep venous thrombosis (DVT);
    • Arterial thrombosis.
  • Receipt of immunotherapy/immunomodulatory or immunosuppressive agents (e.g., IFNs, tumor necrosis factor, interleukins, immunoglobulins or other biologic response modifiers [GM-CSF, GCSF] ≤ 6 weeks prior to registration.

Eligibility last updated 11/30/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Routman, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20526572

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