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Volume 3 Supplement 2

30th Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC 2015)

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High-dose treatment with ADXS11-001, a listeria monocytogenes (Lm)-listeriolysin O (LLO) immunotherapy, in women with cervical cancer


Survival of patients with persistent and recurrent cervical cancer is dismal, and improvement remains a large unmet need. ADXS11-001 is a live, attenuated, bioengineered Lm-LLO immunotherapy for the treatment of human papillomavirus (HPV)-associated cancers such as cervical cancer. ADXS11-001 secretes an HPV-E7 tumor antigen as a truncated LLO-E7 fusion protein that stimulates antitumor immunity through T cells, while reducing immune tolerance via T-regulatory and myeloid-derived suppressor cells. ADXS11-001 has been shown to be safe and effective in women with recurrent/refractory cervical cancer. This Phase I study evaluates whether a higher ADXS11-001 dose than that currently used in Phase II trials is safe and well tolerated.


This is a Phase I, dose-escalation, open-label study (NCT02164461) enrolling women aged ≥18 years with persistent, metastatic, or recurrent squamous/adenocarcinoma of the cervix and documented disease progression (not amenable to surgery/standard radiotherapy). Additional eligibility criteria include: measurable and/or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1); Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; and ≤2 prior treatments for metastatic disease. The primary endpoint is the safety and tolerability of ADXS11-001; secondary endpoints include evaluating tumor response and progression-free survival, and assessing correlative immunologic studies. Patients will receive ADXS11-001 every 3 weeks during a 12-week treatment cycle. Dose escalation is performed using the 3+3 design in 2 doses: 5x109 colony-forming units (CFU; Dose Level 1) and 1x1010 CFU (Dose Level 2). The recommended Phase II dose will be selected based on an observed dose-limiting toxicity (DLT) rate of < 33%. Efficacy is assessed using RECIST v1.1 and immune-related RECIST. Blood samples will be collected in cycle 1 only and used for immune monitoring and cytokine/chemokine analysis.


Enrollment into Dose Level 1 is complete (n=6). Initially 3 patients were enrolled into the first dose cohort; 1 patient experienced grade 3 hypotension as a DLT, resulting in 3 additional patients being enrolled. The mean age is 51.3 years, 66.7% (n=4) had ECOG 0 at baseline, and 83.3% (n=5) patients have squamous histology. All patients received prior cisplatin-based concurrent chemoradiation, plus a median of 1.5 (range 0–5) lines of systemic chemotherapy. A total of 16 doses of ADXS11-001 have been safely administered; accrual for Dose Level 2 is starting. Updated data on the determination of the maximum tolerated dose and efficacy of ADXS11-001 will be presented.

Trial registration identifier NCT02164461.

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

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Ghamande, S., Mauro, D., Price, C. et al. High-dose treatment with ADXS11-001, a listeria monocytogenes (Lm)-listeriolysin O (LLO) immunotherapy, in women with cervical cancer. j. immunotherapy cancer 3 (Suppl 2), P151 (2015).

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