A phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in advanced-stage ovarian cancer: a Korean Gynecologic Oncology Group Study (KGOG 3046), TRU-D

Jung Yun Lee, Jae Weon Kim, Myong Cheol Lim, Sunghoon Kim, Hee Seung Kim, Chel Hun Choi, Ju Yeon Yi, Sang Yoon Park, Byoung Gie Kim, KGOG investigators, Jung Yun Lee, Jae Weon Kim, Myong Cheol Lim, Sunghoon Kim, Hee Seung Kim, Chel Hun Choi, Ju Yeon Yi, Sang Yoon Park, Byoung Gie Kim, KGOG investigators

Abstract

Background: A single-arm phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in the treatment of advanced-stage ovarian cancer has begun in Korea. We hypothesized that adding durvalumab (anti-programmed death-ligand 1 antibody) and tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4 antibody) to chemotherapy in treating this cancer can increase progression-free survival (PFS) with minimal effects on safety.

Methods: During treatment, serial biopsies will be performed on pre-treatment, at interval debulking surgery and progression to identify immune biomarkers and changes in the tumor microenvironment. Patients with histologically confirmed stage IIIC/IV epithelial ovarian cancer are offered durvalumab, tremelimumab plus chemotherapy for neoadjuvant chemotherapy and durvalumab plus chemotherapy for adjuvant chemotherapy. Twenty-four patients will be included from four Korean institutions within 1 year. The primary endpoint is a 12-month PFS rate.

Trial registration: ClinicalTrials.gov Identifier: NCT03899610.

Keywords: Chemotherapy; Durvalumab; Epithelial Ovarian Cancer; Immunotherapy; Tremelimumab.

Conflict of interest statement

Jung-Yun Lee received honoraria for speaker's bureaus from AstraZeneca, Janssen, Roche and research fund from AstraZeneca, Clovis Oncology, Janssen, MSD, Roche for clinical trials or contracted research. Jae-Weon Kim has served on local advisory boards for AstraZeneca, Takeda, Pfizer, Janssen. Received honoraria for speaker's bureaus from AstraZeneca, Takeda, Pfizer, Janssen, Roche. Myoung Chel Lim disclose COI with following companies on the one of the advisory board member, honoraria, research funding or travel for the meeting (AstraZeneca, Cellid, Clovis, MSD, Pfizer, Roche, Takeda & Tessa).

Copyright © 2019. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.

Figures

Fig. 1. Study schema.
Fig. 1. Study schema.
FACS, fluorescence-activated cell sorting; PD-L1, programmed death-ligand 1; Q3W, every 3 weeks.

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Source: PubMed

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