Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combo In Cervical or HPV+ Head & Neck Cancer

Inclusion Criteria:

1. Have histological diagnosis of squamous cell cancer of the head & neck with
confirmation of HPV positivity or squamous, non-squamous, adenosquamous, carcinoma or
adenocarcinoma of the cervix which HPV positivity is not required

2. Have measurable and/or evaluable disease by RECIST 1.1

3. Have ECOG performance status of 0 or 1

4. Have adequate organ function defined by the protocol.:

Exclusion Criteria:

1. Has any prior Grade ≥3 immune-related adverse event (irAE) while receiving
immunotherapy, including anti-CTLA-4 treatment, or any unresolved irAE >Grade 1.

2. Has a diagnosis of immunodeficiency or is receiving any systemic steroid therapy or
any other form of immunosuppressive therapy within 7 days prior to Day 1 of trial
treatment.

3. Has any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for
invasive malignancy within 2 years. Concurrent use of hormones for non-cancer-related
conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.

4. Has an active autoimmune disease requiring systemic treatment within the past 3 months
or a documented history of clinically severe autoimmune disease, or a syndrome that
requires systemic steroids or immunosuppressive agents.

5. 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