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

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ClinicalTrials.gov Identifier: NCT02291055
Recruitment Status : Unknown
Verified February 2020 by Advaxis, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : February 19, 2020
MedImmune LLC
Information provided by (Responsible Party):
Advaxis, Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Cancer Head and Neck Cancer Drug: ADXS11-001 Drug: Medi4736 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Arm A
ADXS11-001& Medi4736, IV Infusion
Drug: ADXS11-001
Drug: Medi4736
Experimental: Arm B
Medi4736, IV Infusion vs. ADXS11-001 & Medi4736, IV Infusion
Drug: ADXS11-001
Drug: Medi4736

Primary Outcome Measures :
  1. Number of subjects with adverse events in each dose level (Part A) [ Time Frame: 2 years ]
  2. Progression Free Survival as measured by RECIST 1.1 an irRECIST (Part B) [ Time Frame: 2 years ]
    Number of subjects with progression free survival

  3. number of subject with adverse event in combination dose (Part B) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291055

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United States, California
Not Yet Recruiting
Los Angeles, California, United States
United States, Connecticut
Not Yet Recruiting
New Haven, Connecticut, United States
United States, Florida
Jacksonville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
United States, Illinois
Urbana, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Maryland
Not Yet Recruiting
Baltimore, Maryland, United States
United States, Michigan
Detroit, Michigan, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
Brooklyn, New York, United States
New York, New York, United States
United States, Ohio
Canton, Ohio, United States
Hilliard, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Tennessee
Chattanooga, Tennessee, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Advaxis, Inc.
MedImmune LLC
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Responsible Party: Advaxis, Inc.
ClinicalTrials.gov Identifier: NCT02291055    
Other Study ID Numbers: ADXS001-04
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Antineoplastic Agents