Study Description: The purpose of this study is to determine whether high risk cervical cancer will respond to a new drug called ADXS11-001. ADXS11-001 is an experimental drug that is intended to stimulate the immune system to respond specifically to the human papillomavirus (HPV) and cervical cancer. HPV comes in over 100 different types; persistent HPV infections are known to be the major risk factor for invasive cervical cancer. The experimental ADXS11-001 drug uses a live strain of the Listeria monocytogenes (Lm) bacteria that has been genetically modified to reduce the risk of infection. Also, this study is being done to determine if ADXS11-001 is safe and effective compared to Placebo in women with HRLACC. A placebo is an inactive material that looks like the study drug but does not contain any active study drug. ADXS11-001 is an investigational drug, which means that it is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of your disease.
Principal Investigator: Sharad Ghamande
Eligibility Criteria: Subjects must be female and at least 18 years of age and older 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). Subject must not have achieved disease-free status after completion of CCRT administered with curative intent. Please see the protocol for a complete list of the eligibility criteria.
Compensation: Yes, subjects will be compensated.
Compensation Explanation: Subjects will be reimbursed through the sponsor's program, Scout Travel Services. Subjects will be reimbursed for travel and lodging costs, lost wages, and maximun allowable amounts related to each of these items consistent with the ICD. Please see the ICD for further explanation, if needed.
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