Nivolumab + deb-TACE for Liver Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byJames Harding, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with confirmed liver cancer (HCC) that can't be removed by surgery or treated with a transplant. They should have measurable disease, be in good physical condition (ECOG 0 or 1), and have well-functioning bone marrow, liver, and kidneys. People with prior liver transplants, certain other cancers, severe allergies to contrast agents used in scans, HIV/AIDS, active autoimmune diseases (with some exceptions), or on high-dose steroids are excluded.

Inclusion Criteria

My liver, kidneys, and bone marrow are functioning well.

Albumin ≥ 2.8 g/dL

My liver cancer cannot be cured with surgery, but it can be treated with a specific procedure.

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Exclusion Criteria

I cannot undergo angiography/embolization due to medical reasons.

You have had a serious allergic reaction to contrast dye in the past, even with medication to prevent it.

Women of childbearing potential (WOCBP) or sexually active men must use appropriate method(s) of contraception.

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Treatment Details

Interventions

Drug Eluting Bead Transarterial Chemoembolization (Chemotherapy)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing the combination of nivolumab (an immunotherapy drug) with deb-TACE—a procedure where chemotherapy drugs are delivered directly to the liver tumor through blood vessels—to see if it's safe and works for treating liver cancer.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort 3, deb-TACE + NivolumabExperimental Treatment2 Interventions

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.

Group II: Cohort 2, deb-TACE + NivolumabExperimental Treatment2 Interventions

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.

Group III: Cohort 1, deb-TACE + NivolumabExperimental Treatment2 Interventions

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.