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

Conditions

• Liver Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Drug Eluting Bead Transarterial Chemoembolization — DRUG
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Apr 28, 2017

Status verified

May 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

20 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1, deb-TACE + Nivolumab
  3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Two weeks after deb-TACE, participants will begin nivolumab every two weeks for up to one year. If no participants experience a dose limiting toxicity (DLT), or 1 of 6 participants experiences a DLT, a new group of participants will be enrolled into Cohort 2.
• Experimental: Cohort 2, deb-TACE + Nivolumab
  3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Participants will receive nivolumab every two weeks for up to one year, starting 4 weeks prior to deb-TACE (week -4). Participants in this cohort will not receive nivolumab on the day of deb-TACE. If no participants experience a DLT in the initial group of 3 participants or if 1 of 6 participants experiences a DLT, a new group of participants will be enrolled into Cohort 3.
• Experimental: Cohort 3, deb-TACE + Nivolumab
  3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Nivolumab will be dosed every two weeks starting 4 weeks prior to deb-TACE (Week 4) and continue every 2 weeks for up to one year. If no participants experience a DLT in the initial group of 3 participants, an additional 3 participants will be added to confirm safety. If less than or equal to 1 of 6 participants experiences a DLT, this will be considered the optimal schedule.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]

Locations (9)

Find similar trials in St Louis, MO

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