Study of ADXS11-001 in Subjects With High Risk Locally Advanced Cervical Cancer



Status:Active, not recruiting
Conditions:Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:September 2016
End Date:October 2024

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Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV

High-risk locally advanced carcinoma of the cervix (HRLACC) following concurrent chemotherapy
and radiation therapy. This is a group of patients with a significant unmet need. The
estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and
the prognosis is very grave for those who experience a recurrence.

The purpose of the study is to compare the disease free survival (DFS) of ADXS11-001 to
placebo administered following CCRT with curative intent in subjects with HRLACC.

This is a double-blind, placebo-controlled randomized study of ADXS11 001 administered in the
adjuvant setting after completion of cisplatin-based CCRT in subjects with locally advanced
cervical cancer at higher risk for recurrence (HRLACC), or death. All eligible subjects will
have received CCRT administered with curative intent according to institutional/national
guidelines as well as meeting the minimum standards defined in the protocol. Subjects must
initiate the Screening period within 10 weeks after the completion of CCRT. Baseline
radiographic assessments and clinical laboratory assessments must be completed no longer than
28 days prior to and 3 days prior to the first study treatment infusion, respectively.
Eligible subjects will be randomized 1:2 to receive either placebo or ADXS11-001. Subjects
will receive 1 infusion of study treatment administered every 3 weeks for 3 doses for the
first 3 months. Thereafter, subjects will receive study treatment every 8 weeks for a total
of 5 doses or until disease recurrence. Subjects will receive a 7-day course of an oral
antibiotic or placebo starting 72 hours following the completion of study treatment
administration.

An interim analysis will be performed when there is at least one-half the number of DFS
events required for full maturity of the study.

Inclusion Criteria:

- Subjects must have a biopsy confirmed diagnosis of squamous cell, adenocarcinoma, or
adenosquamous carcinoma of the cervix. Histologic confirmation of the original primary
tumor is required.

- Subjects must have received definitive therapy with curative intent, which consist of
at least 4 weeks of treatment with cisplatin and a minimum of 40Gy external beam
radiation therapy (EBRT).

- Have performance status of 0 or 1 on the GOG performance scale

- Demonstrate adequate organ function

Exclusion Criteria:

- Has not achieved disease-free status after completion of CCRT administered with
curative intent.

- Has FIGO Stage IVB

- Has histologies other than squamous cell, adenocarcinoma, or adenosquamous carcinoma
of the cervix.

- 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)).

- Has a contraindication (sensitivity or allergy) to trimethoprim/sulfamethoxazole and
ampicillin.

- Has undergone a previous hysterectomy defined as removal of the entire uterus or will
have a hysterectomy as part of their initial cervical cancer therapy. NOTE: Women who
have had a partial/subtotal hysterectomy are eligible to participate in the study
We found this trial at
42
sites
2038 Auburn Avenue
Cincinnati, Ohio 45219
Phone: 844-783-1529
1879
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Cincinnati, OH
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Albany, New York 12205
Phone: 844-783-1529
2437
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Albany, NY
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Augusta, Georgia 30912
Phone: 844-783-1529
2053
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Augusta, GA
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201 Key Highway
Baltimore, Maryland 21230
Phone: 844-783-1529
2302
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Baltimore, MD
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165 7th Street
Brooklyn, New York 11215
Phone: 844-783-1529
2433
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Brooklyn, NY
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Charlotte, North Carolina 28207
Phone: 844-783-1529
2102
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Charlotte, NC
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Chattanooga, Tennessee
Phone: 844-783-1529
1853
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Chattanooga, TN
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Dallas, Texas 75208
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1222
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Dallas, TX
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Detroit, Michigan
Phone: 844-783-1529
1966
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Detroit, MI
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Duarte, California 91010
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5
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Duarte, CA
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Galveston, Texas
Phone: 844-783-1529
1400
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Galveston, TX
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Greenville, South Carolina 29605
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2019
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Greenville, SC
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Hackensack, New Jersey
Phone: 844-783-1529
2430
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Hackensack, NJ
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Hilliard, Ohio
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1952
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Hilliard, OH
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Houston, Texas
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1357
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Houston, TX
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624 South Missouri Street
Indianapolis, Indiana 46225
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1792
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Indianapolis, IN
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Indianapolis, Indiana 46202
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1793
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Indianapolis, IN
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Iowa City, Iowa 52242
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1528
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Iowa City, IA
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Kettering, Ohio 45429
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1898
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Kettering, OH
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La Rioja,
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La Rioja,
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Las Vegas, Nevada 89113
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207
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Las Vegas, NV
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Long Beach, California 90806
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21
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Maywood, Illinois 60153
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1718
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Maywood, IL
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5199 Northeast 2nd Avenue
Miami, Florida 33137
Phone: 844-783-1529
2320
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Miami, FL
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Milwaukee, Wisconsin 53226
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1722
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Minneapolis, Minnesota 55455
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1511
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Mobile, Alabama
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1757
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Mobile, AL
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Nashville, Tennessee 37232
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1763
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Newark, New Jersey 07103
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2424
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Newark, NJ
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Oklahoma City, Oklahoma
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Oklahoma City, OK
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Omaha, Nebraska
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Orange, California 92868
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610 North Batavia Street
Orange, California 92868
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Park Ridge, Illinois
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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4302 East Superior Avenue
Phoenix, Arizona 85040
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349
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San Francisco, California
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355
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Scarborough, Maine 04074
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2611
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Scarborough, ME
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Tallahassee, Florida
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1977
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Tampa, Florida
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Winston-Salem, North Carolina
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2126
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