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

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.

SOUTH Korea; GYNECOLOGIC care; OVARIAN cancer; GYNECOLOGIC oncology; GYNECOLOGIC cancer; OVARIAN epithelial cancer; ADJUVANT treatment of cancer

Journal of Gynecologic Oncology, 2019, Vol 30, Issue 6, p1

2005-0380

Academic Journal

10.3802/jgo.2019.30.e112