Clinical Trials Search
Clinical Trial 18890
Study Type: Treatment
Phase of Study: Phase III
- Hye Sook Chon
Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence)
The purpose of the study is to compare the disease free survival (DFS) of ADXS11-001 to placebo, administered following concurrent chemotherapy and radiotherapy (CCRT) with curative intent in participants with high-risk locally advanced carcinoma of the cervix (HRLACC).
Primary Objective & Hypothesis Objective: 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). Hypothesis: ADXS11-001 administered in the adjuvant setting following definitive therapy with CCRT will significantly improve DFS as compared with placebo. Secondary Objectives: - 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. - To evaluate the overall survival (OS) of ADXS11-001 administered in the adjuvant setting following definitive therapy of CCRT in subjects with HRLACC. Exploratory Objectives: - To evaluate the association between HPV subtypes and DFS and OS. - To determine and compare patient reported outcomes (PROs) of health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx), fatigue as measured by the PROMIS-Cancer-Fatigue Short Form 4a, and pain as measured by a single item of the Brief Pain Inventory (BPI) for ADXS11-001 and placebo.