ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer

This is an investigator-initiated prospective clinical study of patients with stage I-IV
squamous cell carcinoma of the oropharynx (OPSCC) who are to undergo ablative transoral
robotic surgery (TORS).

There is a vaccination group and a control group in this study.

Subjects in the control group will not receive the vaccination and will only be followed
after TORS surgery for additional research blood tests to measure how their immune system is
working.

Subjects in the vaccination group will receive two vaccinations prior to surgery. The first
dose will be about 33 days before surgery, and the second will be about 14 days before
surgery.

Participation in this study will also include allowing the research team to take several
blood samples from the subject at various times before, during, and after treatment for
his/her cancer.

Vaccination subjects will be monitored closely after treatment and includes 6 months of oral
antibiotics.

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
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.