Phase I Study Evaluating High Dose Adxs11-001 Treatment In Women With Carcinoma Of The Cervix.

TPS3096 Background: This is a phase I, dose-escalation, open-label, single-center study, in subjects with carcinoma of the cervix who have failed conventional therapy. ADXS11-001 is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy bioengineered to secret an antigen-adjuvant fusion protein (fused to HPV16 E7). The primary objective of the study is to evaluate the tolerability and safety of ADXS11-001. Secondary objectives are tumor response, progression-free survival and correlative immunologic studies. Methods: Subject eligibility: Women ≥ 18 years of age with histologically-confirmed, measurable and/or evaluable (defined by RECIST 1.1) persistent, metastatic, or recurrent squamous or adenocarcinoma of the cervix with documented disease progression that is not amenable to surgery or standard radiotherapy. Subjects must have received ≤ 2 prior regimens for treatment of their metastatic disease. Planned sample size is approximately 6-12 subjects. Subjects will receive ADXS11-001 every 3 weeks...