ADXS11-001 High Dose HPV+ Cervical Cancer

Inclusion Criteria:

- Patients with histologically-confirmed, persistent, metastatic or recurrent squamous
or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the
cervix with documented disease progression (disease not amenable to surgery or
standard radiotherapy).

- Patients who have received no more than 1 prior cytotoxic treatment regimen.

- Subject may have received ≤2 prior regimens for the treatment of their metastatic
disease.

- Subject is able to provide written informed consent.

- Subject must have an ECOG performance status of 0 or 1.

Exclusion Criteria:

- In the opinion of the investigator, subject has rapidly progressing disease, OR has
life expectancy of less than 6 months, OR would be unable to receive at least one
cycle of therapy.

- Subject has received chemotherapy and/or radiation therapy (except palliative
radiation therapy for disease-related pain) within ≤2 weeks of first ADXS11-001
infusion.

- Subject has a known additional malignancy that is progressing or requires active
treatment. Exceptions include basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or in situ cervical cancer that has undergone potentially
curative therapy.

- Has a contraindication to administration of trimethoprim/sulfamethoxazole or
ampicillin.

- 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. Sponsor must be contacted prior to consenting any subject who has any
other device and/or implant.