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.
Additional locations may be listed on ClinicalTrials.gov for NCT02853604.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationAdvaxis, Inc.
