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 : March 31, 2020
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|
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 (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Reference Treatment Group (Arm A)
Placebo Arm A
Experimental: Experimental Treatment Group (Arm B)
1:2 Arm A to Arm B
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853604
|Principal Investigator:||Thomas J Herzog, MD||University of Cincinnati|
|Principal Investigator:||Brian Slomovitz, MD||Sylvester Comprehensive Cancer Center|