Phase I Study Evaluating High-Dose Treatment With Adxs11-001, A Listeria Monocytogenes-Listeriolysin O (Lm-Llo) Immunotherapy, In Women With Cervical Cancer.

e14580Background: Survival of patients (pts) with persistent, metastatic or recurrent cervical cancer is dismal. ADXS11-001 is an irreversibly attenuated Lm-LLO immunotherapy secreting a human papillomavirus-E7 tumor antigen as a truncated LLO-E7 fusion protein that induces antitumor T-cell immunity and reduces tumor immune tolerance. In pts with recurrent/refractory cervical cancer, ADXS11-001 was shown to be safe and effective. This study evaluates the safety/efficacy of a higher ADXS11-001 dose than that currently used in phase II trials. Methods: This phase I, dose-escalation, open-label study (NCT02164461) enrolled women ≥ 18 years with persistent, metastatic, or recurrent cervical squamous/adenocarcinoma not amenable to surgery/standard radiotherapy. Pts had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0–1 and measurable disease (RECIST v1.1) with documented progression on or intolerance to prior therapy. The primary endpoint was ADXS11-001 safety/tolerability; secondary end...