Clinical Trial 18890

Cancer Type: Gynecological Tumor
Interventions:ADXS11-001; Placebo

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Hye Sook Chon

Overview

Study Title

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)

Summary

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).

Objective

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.

Inclusion Criteria

  • Participants must have a biopsy confirmed diagnosis of squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix. Histologic confirmation of the original primary tumor is required.
  • Must have received definitive therapy with curative intent, which consist of at least 4 weeks of treatment with cisplatin and a minimum of 40Gy external beam radiation therapy (EBRT).
  • Have performance status of 0 or 1 on the GOG performance scale
  • Demonstrate adequate organ function

  • Exclusion Criteria

  • Has not achieved disease-free status after completion of CCRT administered with curative intent.
  • Has FIGO Stage IVB
  • Has histologies other than squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix.
  • Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)).
  • Has a contraindication (sensitivity or allergy) to trimethoprim/sulfamethoxazole and ampicillin.
  • Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy. NOTE: Women who have had a partial/subtotal hysterectomy are eligible to participate in the study