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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
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Advaxis, Inc.

Tracking Information
First Submitted Date  ICMJE November 6, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date February 19, 2020
Study Start Date  ICMJE April 2015
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2016)
  • Number of subjects with adverse events in each dose level (Part A) [ Time Frame: 2 years ]
  • Progression Free Survival as measured by RECIST 1.1 an irRECIST (Part B) [ Time Frame: 2 years ]
    Number of subjects with progression free survival
  • number of subject with adverse event in combination dose (Part B) [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
  • Number of subjects with adverse events in each dose level (Part A) [ Time Frame: 2 years ]
    Number of subjects with adverse events in each dose level
  • Number of subjects with progression free survival (Part B) [ Time Frame: 2 years ]
    Number of subjects with progression free survival
  • Number of subjects with adverse event in combination dose (Part B) [ Time Frame: 2 years ]
    Number of subjects with adverse event in combination dose
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combo In Cervical or HPV+ Head & Neck Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Cancer
  • Cancer
  • Head and Neck Cancer
Intervention  ICMJE
  • Drug: ADXS11-001
  • Drug: Medi4736
Study Arms  ICMJE
  • Experimental: Arm A
    ADXS11-001& Medi4736, IV Infusion
    Interventions:
    • Drug: ADXS11-001
    • Drug: Medi4736
  • Experimental: Arm B
    Medi4736, IV Infusion vs. ADXS11-001 & Medi4736, IV Infusion
    Interventions:
    • Drug: ADXS11-001
    • Drug: Medi4736
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2014)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291055
Other Study ID Numbers  ICMJE ADXS001-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Advaxis, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Advaxis, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE MedImmune LLC
Investigators  ICMJE Not Provided
PRS Account Advaxis, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP