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
- Authors
- Lee, J.Y.[Lee, J.Y.]; Kim, J.W.[Kim, J.W.]; Lim, M.C.[Lim, M.C.]; Kim, S.[Kim, S.]; Kim, H.S.[Kim, H.S.]; Choi, C.H.[Choi, C.H.]; Yi, J.Y.[Yi, J.Y.]; Park, S.Y.[Park, S.Y.]; Kim, B.G.[Kim, B.G.]
- Issue Date
- Nov-2019
- Publisher
- NLM (Medline)
- Keywords
- Chemotherapy; Durvalumab; Epithelial Ovarian Cancer; Immunotherapy; Tremelimumab
- Citation
- Journal of gynecologic oncology, v.30, no.6, pp.e112
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- Journal of gynecologic oncology
- Volume
- 30
- Number
- 6
- Start Page
- e112
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/14074
- DOI
- 10.3802/jgo.2019.30.e112
- ISSN
- 2005-0399
- 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. Copyright © 2019. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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