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  • TP003/#1557  An open label, single arm, multicenter trial of durvalumab and BVAC-C, in patients with HPV 16 or 18 positive cervical cancer (DURBAC)

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ePoster Viewing: Trials-in-Progress
AS03. Cervical cancer
TP003/#1557  An open label, single arm, multicenter trial of durvalumab and BVAC-C, in patients with HPV 16 or 18 positive cervical cancer (DURBAC)
Free
  1. Chel Hun Choi1,
  2. Byoung Gie Kim2,
  3. Jeong-Won Lee2,
  4. Tae-Joong Kim2,
  5. Yoo Young Lee3,
  6. Duck Cho2,
  7. Byoung-Kwan Park3,
  8. Sang Yong Song2,
  9. Dae-Yeon Kim4,
  10. Kidong Kim5,
  11. Hee Seung Kim6,
  12. Jung-Yun Lee7,
  13. Myong Cheol Lim8,
  14. Wu_Hyun Kim9 and
  15. Chang Yuil Kang9
  1. 1Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  2. 2Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea, Republic of
  3. 3Samsung Medical Center, Obstetrics and Gynecology, Seoul, Korea, Republic of
  4. 4Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  5. 5Seoul National University Bundang Hospital, Department of Obstetrics and Gynecology, Seongnam-Si, Korea, Republic of
  6. 6Seoul National University Hospital, Obstetrics and Gynecology, Seoul, Korea, Republic of
  7. 7Yonsei University Health System, Obstetrics and Gynecology, Seoul, Korea, Republic of
  8. 8Center for Gynecologic Cancer, National Cancer Center, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of
  9. 9Cellid, Phamacology, Seoul, Korea, Republic of

Abstract

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.

https://doi.org/10.1136/ijgc-2023-IGCS.466

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