Description:
Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and
tolerability of the combination and to identify a RP2D.
Part B:
Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or
MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their
recurrent/persistent or metastatic cervical cancer.
Title
- Brief Title: Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combo In Cervical or HPV+ Head & Neck Cancer
- Official Title: Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combination In Previously Treated Locally Advanced or Metastatic Cervical or HPV+ Head & Neck Cancer
Clinical Trial IDs
- ORG STUDY ID:
ADXS001-04
- NCT ID:
NCT02291055
Conditions
- Cervical Cancer
- Cancer
- Head and Neck Cancer
Interventions
Drug | Synonyms | Arms |
---|
ADXS11-001 | | Arm A |
Medi4736 | | Arm A |
Purpose
Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and
tolerability of the combination and to identify a RP2D.
Part B:
Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or
MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their
recurrent/persistent or metastatic cervical cancer.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | ADXS11-001& Medi4736, IV Infusion | |
Arm B | Experimental | Medi4736, IV Infusion vs. ADXS11-001 & Medi4736, IV Infusion | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of subjects with adverse events in each dose level (Part A) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Number of subjects with progression free survival |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Advaxis, Inc. |
Last Updated
February 19, 2020