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

NCT03143270 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-07

No results posted yet for this study

Summary

The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • James Harding, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143270 on ClinicalTrials.gov