Clinical Trials /

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

NCT02853604

Description:

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.

Related Conditions:
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: ADXS001-02
  • NCT ID: NCT02853604

Conditions

  • High Risk Cervical Cancer
  • Advanced Cervical Cancer

Interventions

DrugSynonymsArms
ADXS11-001Experimental Treatment Group (Arm B)
PlaceboReference Treatment Group (Arm A)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Reference Treatment Group (Arm A)Placebo ComparatorPlacebo Arm A
  • Placebo
Experimental Treatment Group (Arm B)ExperimentalADXS11-001 1:2 Arm A to Arm B
  • ADXS11-001

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease free survival (DFS)
Time Frame:5 Years
Safety Issue:
Description: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

Measure:Safety & tolerability Overall survival (OS)
Time Frame:5 Years
Safety Issue:
Description: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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Advaxis, Inc.

Last Updated

June 7, 2017