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

• ClinicalTrials.gov Identifier: NCT02853604
• Recruitment Status: Active, not recruiting
• First Posted: August 3, 2016
• Last Update Posted: August 12, 2020
• Sponsor: Advaxis, Inc.
• Collaborator: Gynecologic Oncology Group
• Information provided by (Responsible Party): Advaxis, Inc.

Tracking Information

• First Submitted Date: July 28, 2016
• First Posted Date: August 3, 2016
• Last Update Posted Date: August 12, 2020
• Study Start Date: September 2016
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of ADXS11-001 in Subjects With High Risk Locally Advanced Cervical Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• High Risk Cervical Cancer
• Advanced Cervical Cancer

Intervention

• Drug: ADXS11-001
• Drug: Placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 29, 2016): 450
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Brazil, Canada, Chile, Korea, Republic of, Malaysia, Mexico, Poland, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United States

Administrative Information

• NCT Number: NCT02853604
• Other Study ID Numbers: ADXS001-02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Advaxis, Inc.
• Study Sponsor: Advaxis, Inc.
• Collaborators: Gynecologic Oncology Group

Investigators

• Principal Investigator: Thomas J Herzog, MD; University of Cincinnati
• Principal Investigator: Brian Slomovitz, MD; Sylvester Comprehensive Cancer Center

• PRS Account: Advaxis, Inc.
• Verification Date: August 2020