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

• Status: Active, not recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

High-risk locally advanced carcinoma of the cervix (HRLACC) following concurrent chemotherapy and radiation therapy. This is a group of patients 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 is to compare the disease free survival (DFS) of ADXS11-001 to placebo administered following CCRT with curative intent in subjects with HRLACC.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advaxis, Inc.
• Collaborator: Gynecologic Oncology Group

Criteria

Inclusion Criteria:

• Subjects 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.

• Subjects 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