Status:
TERMINATED
A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
Lead Sponsor:
Advaxis, Inc.
Collaborating Sponsors:
MedImmune LLC
Conditions:
Cervical Cancer
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This was a multicenter, open-label, 2-part randomized study of MEDI4736 administered as monotherapy or in combination with ADXS11-001 to participants with recurrent/persistent or metastatic squamous o...
Detailed Description
The study was conducted in 2 parts Part A (dose-escalation and expansion) and Part B (expansion). Part A: Part A of the study was a Phase 1 dose escalation evaluation of the combination treatment of...
Eligibility Criteria
Inclusion
- Have histological diagnosis of SCCHN with confirmation of HPV positivity or squamous, non-squamous, adenosquamous, carcinoma or adenocarcinoma of the cervix which HPV positivity is not required
- Have measurable and/or evaluable disease by response evaluation criteria in solid tumors (RECIST) 1.1
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate organ function defined by the protocol.
Exclusion
- Has any prior Grade ≥3 immune-related adverse event (irAE) while receiving immunotherapy, including anti-CTLA-4 treatment, or any unresolved irAE \>Grade 1.
- 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.
- 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.
- 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.
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02291055
Start Date
April 1 2015
End Date
November 20 2020
Last Update
March 20 2023
Active Locations (17)
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1
Site
Los Angeles, California, United States
2
Site
New Haven, Connecticut, United States
3
Site
Jacksonville, Florida, United States
4
Site
Miami, Florida, United States