A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 28, 2017

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Liver Cancer
Interventions
DRUG

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.

DRUG

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.

Trial Locations (9)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Cancer Commack, Commack

63110

Washington University School of Medicine, St Louis

07920

Memorial Sloan Kettering at Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

19104-4283

Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03143270 - A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer | Biotech Hunter | Biotech Hunter