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Study of ADXS11-001 in Subjects With High Risk Locally Advanced Cervical Cancer (AIM2CERV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853604
Recruitment Status : Active, not recruiting
First Posted : August 3, 2016
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Advaxis, Inc.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
High Risk Cervical Cancer Advanced Cervical Cancer Drug: ADXS11-001 Drug: Placebo Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV
Study Start Date : September 2016
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Reference Treatment Group (Arm A)
Placebo Arm A
 Drug: Placebo
Experimental: Experimental Treatment Group (Arm B)

ADXS11-001

1:2 Arm A to Arm B

 Drug: ADXS11-001


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: 5 Years ]
    To compare the disease free survival (DFS) of ADXS11-001 to placebo administered in the adjuvant setting following concurrent chemotherapy and radiotherapy (CCRT) administered with curative intent to subjects with high-risk locally advanced squamous, adenosquamous, or adenocarcinoma of the cervix (HRLACC).


Secondary Outcome Measures :
  1. Safety & tolerability Overall survival (OS) [ Time Frame: 5 Years ]
    To determine and compare the frequency and severity of adverse events (AEs) as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the regimens administered on this study.


Eligibility Criteria
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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:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02853604


Locations
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Sponsors and Collaborators
Advaxis, Inc.
Gynecologic Oncology Group
Investigators
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Principal Investigator: Thomas J Herzog, MD University of Cincinnati
Principal Investigator: Brian Slomovitz, MD Sylvester Comprehensive Cancer Center
More Information
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Responsible Party: Advaxis, Inc.
ClinicalTrials.gov Identifier: NCT02853604    
Other Study ID Numbers: ADXS001-02
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female