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KMID : 1137020190300060112
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Journal of Gynecologic Oncology
2019 Volume.30 No. 6 p.112 ~ p.112
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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
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Lee Jung-Yun
Kim Jae-Weon
Lim Myong-Cheol
Kim Sung-Hoon
Kim Hee-Seung
Choi Chel-Hun
Yi Ju-Yeon
Park Sang-Yoon
Kim Byoung-Gie
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Abstract
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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.
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KEYWORD
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Epithelial Ovarian Cancer, Chemotherapy, Durvalumab, Tremelimumab, Immunotherapy
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