NCT02853604

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

Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Advaxis, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Locally advanced cervical cancer at higher risk for recurrence (HRLACC) following concurrent chemotherapy and radiation therapy. This is a group of participants 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 was to compare the disease free survival (DFS) of ADXS11-001 to placebo administered following cisplatin-based combination chemotherapy and radiation (CCRT) with curative intent in participants with HRLACC.

Detailed description

This was a double-blind, placebo-controlled randomized study of ADXS11-001 administered in the adjuvant setting after completion of CCRT in participants with HRLACC, or death. All eligible participants had received CCRT administered with curative intent according to institutional/national guidelines as well as meeting the minimum standards defined in the protocol. Participants initiated the Screening period within 10 weeks after the completion of CCRT. Baseline radiographic assessments and clinical laboratory assessments were completed no longer than 28 days prior to and 3 days prior to the first study treatment infusion, respectively. Eligible participants were randomized 1:2 to receive either placebo or ADXS11-001. Participants received 1 infusion of study treatment administered every 3 weeks for 3 doses for the first 3 months. Thereafter, participants received study treatment every 8 weeks for a total of 5 doses or until disease recurrence. Participants received a 7-day course of an oral antibiotic or placebo starting 72 hours following the completion of study treatment administration.

Conditions

• High Risk Cervical Cancer
• Advanced Cervical Cancer

Interventions

Type	Name	Description
DRUG	ADXS11-001
DRUG	Placebo

Timeline

• Start date: 2015-12-15
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2016-08-03
• Last updated: 2023-03-14
• Results posted: 2023-03-14

Locations

117 sites across 14 countries: United States, Argentina, Brazil, Canada, Chile, Malaysia, Mexico, Poland, Russia, Serbia, South Korea, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study