Introduction BVAC-C, a novel B cell- and monocyte-based immunotherapeutic vaccine transfected with recombinant HPV E6/E7, exhibited favorable tolerability in the phase I study of recurrent cervical carcinoma. This ongoing clinical trial aims to assess the potential synergistic effect of BVAC-C and durvalumab (MEDI4736) in enhancing anti-tumor immune responses. The trial focuses on patients with HPV 16 or 18 positive cervical cancer that is recurrent after or refractory to first-line platinum-based chemotherapy +/- bevacizumab.
Methods The trial is divided into two phases. In Part A, a 3+3 dose-escalation design investigates BVAC-C combined with 1500 mg durvalumab to establish the maximum tolerated dose (MTD) and recommended phase 2 dose. After determining the phase 2 dose, Part B proceeds with a phase 2 expansion involving up to 25 patients. The evaluation in Part B centers on both safety and clinical efficacy, as gauged by the 6-month progression-free survival (PFS) rate. Tumor response evaluation adheres to RECIST 1.1 criteria and iRECIST. Exploratory study: In addition to evaluating clinical outcomes, an exploratory study is ongoing to identify potential biomarkers, including PD-L1 expression, tumor mutational burden (TMB), and HLA typing. These assessments are conducted using tumor samples and blood specimens.
Current Trial Status Enrolment for Part A commenced in September 2021 across six Korean centers. Part A, encompassing 9 patients, concluded in June 2022. Currently, Part B is actively enrolling patients with 15 participants enrolled so far.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.