ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer
Condition: Head and Neck Cancer; Squamous Cell Carcinoma of the Head and Neck; HPV Positive Oropharyngeal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: ADXS11-001 (ADXS-HPV)
Intervention description: ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HPV; oropharynx; squamous cell carcinoma; head and neck cancer; transoral robotic surgery

Summary:

      Some cancers may be related to an infection with a virus, such as the Human Papilloma Virus
      (HPV). HPV related Oropharyngeal cancer (HPVOPC) accounts for 80% of oropharynx cancer cases
      in the United States. HPVOPC has better prognosis than patients with HPV negative oropharynx
      cancer. In many hospitals, the standard of care treatment for oropharyngeal cancer is surgery
      and/or radiotherapy with or without chemotherapy. While chances of survival for most patients
      with HPVOPC is very good, current treatments are associated with short- and long-term side
      effects which can be severe. In pre-clinical research using animal models of cancer,
      vaccination targeting the HPV virus has been found to cause tumor regression. Thus,
      approaches which target the unique characteristics of HPV-infected cancer cells, such as
      therapeutic vaccination, are attractive strategies for potentially reducing radiotherapy and
      chemo radiotherapy regimens (and thus decreasing toxicity) and enhancing long-term disease
      control.

      The purpose of this study is to see if an experimental vaccine, ADXS11-001, is effective in
      stimulating the body's defense system against HPV-positive oropharyngeal squamous cell
      carcinoma before transoral (through the mouth) surgery. The experimental product ADXS11-001
      uses a live strain of the Listeria monocytogenes (Lm) bacteria that has been genetically
      modified such that the risk of getting an infection is significantly reduced. Several
      research studies have already been conducted with ADXS11-001 in men and women with cancer. So
      far, approximately 722 doses of ADXS11-001 have been given to 290 patients with HPV
      associated cancers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has newly-diagnosed, biopsy proven squamous cell carcinoma of Stage I-IV
             (T1-3, N0-2b) of the oropharynx.

          -  The patient's tumor is HPV positive by PCR or ISH assay of tumor biopsy.

          -  The patient is able/eligible to undergo treatment with transoral robotic surgery
             (TORS) with or without neck dissection and with or without adjuvant radiation therapy
             or chemoradiation.

          -  The patient is able to understand and give informed consent.

          -  The patient is at least 18 years old.

          -  The patient's ECOG performance status is </= 2.

        Exclusion Criteria:

          -  The patient has had prior head and neck squamous cell carcinoma (HNSCC), with the
             exception of superficial cutaneous basal cell or squamous cell carcinomas.

          -  The patient has active cancer in another part of the body, with the exception of
             superficial cutaneous basal cell or squamous cell carcinomas

          -  If a cancer survivor, the disease free interval is less than 3 years, with the
             exception of superficial cutaneous basal cell or squamous cell carcinomas.

          -  If a cancer survivor the patient received prior systemic chemotherapy or radiotherapy

          -  If prior standard-of-care pre-treatment biopsy is inadequate for analysis by
             immunohistochemistry, and the patient is unwilling to undergo an additional biopsy
             procedure.

          -  The patient is a prisoner.

          -  The patient has a psychiatric illness or developmental delay which would interfere
             with understanding of the study and provision of informed consent.

          -  The patient has previously received definitive surgical, radiation, or chemoradiation
             treatment for HNSCC.

          -  The patient has a history of HIV or other known cause of immunosuppression, or is
             actively taking immunosuppressive medications due to organ transplantation, rheumatoid
             disease, or other medical conditions.

          -  Patient is allergic to naproxen or Ibuprofen.

          -  The patient has a history of liver disease.

          -  The patient has a contraindication (e.g. sensitivity/allergy) to both
             trimethoprim/sulfamethoxazole and ampicillin.

          -  The patient has implanted medical device(s) that pose a high risk for colonization
             and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves,
             pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous
             implant(s)). NOTE: More common devices and prosthetics which include arterial and
             venous stents, dental and breast implants and venous access devices (e.g. Port-a-Cath
             or Mediport) are permitted.

          -  Patients who are receiving or may receive future treatment with PI3K or TNFα
             inhibitors.

          -  Patients who have undergone a major surgery, including surgery for a new artificial
             implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment.
             Sponsor must be consulted prior to enrolling subjects on the study who recently had a
             major surgery or have new artificial implant, and/or devices.

          -  Patients who have a history of listeriosis or prior ADXS11-001 therapy.

          -  Patients with a known allergy to any component of the study treatment formulations.

          -  Pregnancy. The effects of this vaccine on the developing human fetus are unknown. For
             this reason women of child-bearing potential and men must use two forms of
             contraception (i.e., barrier contraception and one other method of contraception) at
             least 4 weeks prior to study entry, for the duration of study participation, Should a
             woman become pregnant or suspect she is pregnant while participating in this study,
             she should inform her treating physician immediately.