Phase II randomized study of pembrolizumab with or without epigenetic modulation with CC-486 in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer (TRIO026)
Johns Hopkins Kimmel Cancer Center in Baltimore
The main purpose of this study is to define the optimal administration schedule for a new oral anticancer drug, CC-486, combined with an immunotherapy, pembrolizumab.
The study is intended for adult subjects with ovarian, fallopian tube or peritoneal cancer, that have been previously treated with chemotherapy that included platinum (a specific type of chemotherapy) and whose disease relapsed within 6 months of completing pre or post-operative chemotherapy.
This study is divided in two parts. You will be asked to participate in Part A only. All participants will be treated with pembrolizumab administered through the vein every 3 weeks. Additionally, all participants with receive CC-486. Four different combinations will be tested according to the schedule and dosage of CC-486. At the end of Part A, the optimal administration schedule will be selected to use in Part B of the study. Mandatory tissue and blood samples will also be collected for analysis.
03/05/2019 05:03 AM