drugset / Trial / NCT02853604

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

NCT02853604

Phase 3 Terminated 110 enrolled Advaxis, Inc. Gynecologic Oncology Group · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-12-15
Primary completion
2019-07-31
Completion
2019-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ADXS11-001 Vaccine 1e+09 unknown Intravenous

Indications