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Trial record 3 of 13 for:    Advaxis

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 : March 5, 2019
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Advaxis, Inc.

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 3, 2016
Last Update Posted Date March 5, 2019
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02853604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ADXS11-001 in Subjects With High Risk Locally Advanced Cervical Cancer
Official Title  ICMJE Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • High Risk Cervical Cancer
  • Advanced Cervical Cancer
Intervention  ICMJE
  • Drug: ADXS11-001
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Reference Treatment Group (Arm A)
    Placebo Arm A
    Intervention: Drug: Placebo
  • Experimental: Experimental Treatment Group (Arm B)

    ADXS11-001

    1:2 Arm A to Arm B

    Intervention: Drug: ADXS11-001
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2016)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 Argentina,   Brazil,   Canada,   Chile,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Russian Federation,   Serbia,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02853604
Other Study ID Numbers  ICMJE ADXS001-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Advaxis, Inc.
Study Sponsor  ICMJE Advaxis, Inc.
Collaborators  ICMJE Gynecologic Oncology Group
Investigators  ICMJE
Principal Investigator: Thomas J Herzog, MD University of Cincinnati
Principal Investigator: Brian Slomovitz, MD Sylvester Comprehensive Cancer Center
PRS Account Advaxis, Inc.
Verification Date March 2019

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