Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001 in Treating Patients with HPV Positive Stage I-IV Oropharyngeal Squamous Cell Carcinoma

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 polymerase chain reaction (PCR) or in situ hybridization (ISH) assay of tumor biopsy
• The patient is able/eligible to undergo treatment with transoral surgery (transoral laser microsurgery [TOLM] or 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's Eastern Cooperative Oncology Group (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 that 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 human immunodeficiency virus (HIV) or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions
• The patient is allergic to naproxen or ibuprofen
• The patient has a history of liver disease (excluding Gilbert’s disease and non-active hepatitis C) and/or elevation of transaminases or bilirubin above the normal limit
• 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; the study chair must be contacted prior to consenting any subject who has any other device and/or implant
• Patients who are receiving or may receive future treatment with PI3K or TNFalpha 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; NOTE: All toxicities and/or complications must have recovered to baseline or grade 1 prior to the initiation of ADXS11-001 study therapy; 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 prior ADXS11-001 therapy
• Patients with a known allergy to any component of the study treatment formulations
• 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; women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 10-14 days prior to the first vaccine, within 24 hours prior to the first and second doses of vaccine and prior to surgery * Women of childbearing potential are defined as follows: ** Patients with regular menses ** Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding ** Women who have had a tubal ligation * Women are considered not to be of childbearing potential for the following reasons: ** The patient has undergone hysterectomy and/or bilateral oophorectomy ** The patient is post-menopausal defined by amenorrhea for at least 1 year in a woman > 45 years old