Phase I study evaluating high dose ADXS11-001 treatment in women with carcinoma of the cervix.

Developmental Therapeutics—Immunotherapy
Session Type and Session Title: 
Poster Session, Developmental Therapeutics—Immunotherapy
Abstract Number: 


Poster Board Number: 
Board #417b
J Clin Oncol 33, 2015 (suppl; abstr TPS3096)
Sharad A. Ghamande, Robin Dobbins, Lisa Marshall, Donna Wheatley, Cheryl Prince, David J. Mauro, John Edward Janik, Samir Khleif; Georgia Regents Univ, Augusta, GA; GRU Cancer Center, Georgia Reagents University, Augusta, GA; Advaxis Inc, Princeton, NJ; Georgia Health Scis Univ Cancer Ctr, North Augusta, GA; Georgia Regents University Cancer Center, Augusta, GA

Abstract Disclosures


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 during a 12- week treatment cycle. Doses will be escalated in the standard 3 + 3 fashion, in two doses, starting with 5 x 109 colony forming units (cfu) to a maximum dose level of 1 x 1010 cfu. If DLT is seen in one of 3 subjects, another 3 subjects will be treated at that same dose. If DLT is seen in 2 of 6 subjects, then that dose level will be considered maximum tolerated dose (MTD) and the previous dose level will be selected as the recommended phase II dose (RP2D). Blood samples will be evaluated for immunologic effects in cycle 1 only. Treatment cycles can be repeated at the RP2D (or less) for an individual subject until a discontinuation criterion is met, including documented disease progression, intolerable side effects. The end of study will be defined as 1 year after the last subject’s first treatment or until that subject has met a discontinuation criterion. Assessment of the RP2D level may be further explored in an expansion cohort of 15 subjects. Clinical trial information: NCT02164461