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.

Autor: 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
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Zdroj: Journal of Gynecologic Oncology; Nov2019, Vol. 30 Issue 6, p1-8, 8p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index