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Trial record 2 of 4 for:    advaxis head and neck

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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Advaxis, Inc.
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Advaxis, Inc.
ClinicalTrials.gov Identifier:
NCT02291055
First received: November 6, 2014
Last updated: January 18, 2017
Last verified: January 2017
  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.


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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Advaxis, Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 66
Study Start Date: April 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02291055

Contacts
Contact: Advaxis Hotline 844-783-1529

Locations
United States, California
Not Yet Recruiting Not yet recruiting
Los Angeles, California, United States
United States, Connecticut
Not Yet Recruiting Recruiting
New Haven, Connecticut, United States
United States, Florida
Site Recruiting
Jacksonville, Florida, United States
Contact: Advaxis Hotline    844-783-1529      
Recruiting Recruiting
Miami, Florida, United States
Site Recruiting
Tampa, Florida, United States
Contact: Advaxis Hotline    844-783-1529      
United States, Illinois
Site Recruiting
Urbana, Illinois, United States
Contact: Advaxis Hotline    844-783-1529      
United States, Kentucky
Site Recruiting
Lexington, Kentucky, United States
Contact: Advaxis Hotline    844-783-1529      
United States, Maryland
Not Yet Recruiting Recruiting
Baltimore, Maryland, United States
United States, Michigan
Site Recruiting
Detroit, Michigan, United States
Contact: Advaxis Hotline    844-783-1529      
United States, Nebraska
Site Recruiting
Omaha, Nebraska, United States
Contact: Advaxis Hotline    844-783-1529      
United States, New York
Site Recruiting
Brooklyn, New York, United States
Contact: Advaxis Hotline    844-783-1529      
Recruiting Recruiting
New York, New York, United States
United States, Ohio
Recruiting Recruiting
Canton, Ohio, United States
Site Recruiting
Hiliard, Ohio, United States
Contact: Advaxis Hotline    844-783-1529      
United States, Oklahoma
Recruiting Recruiting
Oklahoma City, Oklahoma, United States
United States, Tennessee
Site Recruiting
Chattanooga, Tennessee, United States
Contact: Advaxis Hotline    844-783-1529      
United States, Wisconsin
Site Recruiting
Milwaukee, Wisconsin, United States
Contact: Advaxis Hotline    844-783-1529      
Sponsors and Collaborators
Advaxis, Inc.
MedImmune LLC
  More Information

Responsible Party: Advaxis, Inc.
ClinicalTrials.gov Identifier: NCT02291055     History of Changes
Other Study ID Numbers: ADXS001-04
Study First Received: November 6, 2014
Last Updated: January 18, 2017

Additional relevant MeSH terms:
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017