20
Participants
Start Date
April 28, 2017
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2026
Drug Eluting Bead Transarterial Chemoembolization
Hepatic embolization will occur on Day 0 of the study for all cohorts. On the day of the procedure, baseline angiography including celiac and superior mesenteric angiography will be performed to delineate arterial anatomy and blood supply to the tumor. After the entire dose has been used, the embolized vessels will be re-catheterized and embolized to stasis with Bead Block beginning with 100-300 micron spheres and using a maximum of 10 cc of any given size per vessel before moving to the next size microsphere.
Nivolumab
All participants will receive at a flat dose of 240 mg IV q 12 weeks for up to one year. In cohort 1, participants will begin nivolumab two weeks (+/- 5 days) after deb-TACE every two weeks. In cohort 2, participants will begin nivolumab every 2 weeks for 1 year and undergo deb-TACE 4 weeks after the initiation of nivolumab (+/- 5 day). Nivolumab will not be dosed on the day of embolization in this cohort. In cohort 3, nivolumab will be dosed every two weeks starting 4 weeks (+/- 5 days) prior to deb-TACE and continue every 2 weeks for up to one year. Nivolumab will be dosed on the day of embolization in this cohort. It will be administered before the deb-TACE procedure.
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Westchester, Harrison
Memorial Sloan Kettering Nassau, Uniondale
Memorial Sloan Kettering Cancer Commack, Commack
Washington University School of Medicine, St Louis
Memorial Sloan Kettering at Basking Ridge, Basking Ridge
Memorial Sloan Kettering Monmouth, Middletown
Memorial Sloan Kettering Bergen, Montvale
Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER