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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

Other Titles
 . 
Authors
 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 
Citation
 JOURNAL OF GYNECOLOGIC ONCOLOGY, Vol.30(6) : e112, 2019 
Journal Title
 JOURNAL OF GYNECOLOGIC ONCOLOGY 
ISSN
 2005-0380 
Issue Date
2019
Keywords
Chemotherapy ; Durvalumab ; Epithelial Ovarian Cancer ; Immunotherapy ; Tremelimumab
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.
Files in This Item:
T201904595.pdf Download
DOI
10.3802/jgo.2019.30.e112
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Sung Hoon(김성훈) ORCID logo https://orcid.org/0000-0002-1645-7473
Lee, Jung-Yun(이정윤) ORCID logo https://orcid.org/0000-0001-7948-1350
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/173416
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