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

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.

Trial Description

Primary Outcome:

  • Disease free survival (DFS)
Secondary Outcome:
  • Safety & tolerability Overall survival (OS)
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society