Phase 1 (ADXS11-001 + MEDI4736 Combination Therapy) Phase 1 will be a dose-confirmation
safety run-in of ADXS11-001 and MEDI4736 combination therapy.
Mandatory fresh biopsies will be obtained pre- and during treatment.
48 subjects will be randomized 1:1:2 to receive ADXS11-001 monotherapy, MEDI4736 monotherapy
or ADXS11 001 + MEDI4736 combination therapy.
Arm A: ADXS11-001 Monotherapy:
Arm B: MEDI4736 Monotherapy:
Arm C: ADXS11-001 + MEDI4736 combination therapy
1. Be willing and able to provide written informed consent for the trial 2. Be 18 years
of age on day of signing informed consent 3. Have histologically 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 5. Have measurable and/or evaluable disease by RECIST 1.1 6.
Have ECOG performance status of 0 or 1 7. Have adequate organ function defined by the
protocol.: 8. Female subjects of childbearing potential (not surgically sterilized or not
free from menses for > 1 year): must have a negative urine or serum pregnancy test results
within 72 hours prior to first dose and must be willing to use 2 methods of birth control
through 120 days after the last dose of study treatment.
9. Male subjects must agree to use 2 acceptable methods of effective contraception from
Day 1 thru 120 days after receipt of the final dose of investigational product.
1. Has not recovered (i.e., Grade 1 or at baseline) from adverse events, with the
exception of alopecia, due to a previously administered agent.
2. Has any prior Grade 3 immune-related adverse event (irAE) while receiving
immunotherapy, including anti-CTLA-4 treatment, or any unresolved irAE >Grade 1.
3. Has any pulmonary, ocular, or central nervous system (CNS) toxicity while receiving
prior immunotherapy that has not resolved to <Grade 1.
4. Requires additional immunosuppression beyond corticosteroids for resolution of
5. Is currently participating in or has participated in a study of an investigational
agent or using an investigational device within 4 weeks of the first dose of
6. 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
7. 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.
8. 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.
9. Has evidence of interstitial lung disease or active, non-infectious pneumonitis,
active or prior documented inflammatory bowel diseases (e.g., Crohn's disease,
10. Has an active infection requiring systemic therapy. Prior to dosing with study
drug(s), the subject must be at least 5 half lives from their last dose of
11. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator.
12. Has a history of psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
13. Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
14. Has known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA
[qualitative] is detected).
15. Has a contraindication to administration of non-steroidal anti-inflammatory drugs
16. Has a known allergy to any component of the study drug(s) formulations
17. Has received a live vaccine within 30 days prior to the first dose of trial
18. Has a history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
pneumonitis, organizing pneumonia, risk of pulmonary toxicity, or evidence of active
pneumonitis on screening chest CT scan.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both