A Study Assessing Nivolumab Immunotherapy Added to Chemoembolization for Liver Cancer

Full Title

MCT: A Multicenter Pilot Study of Nivolumab with Drug Eluting Bead Transarterial Chemoembolization in Patients with Advanced Hepatocellular Carcinoma

Purpose

Liver cancers that cannot be surgically removed or treated with liver transplantation are sometimes treated with embolization. Chemoembolization is when doctors perform a procedure to send tiny glass beads with chemotherapy through the arteries supplying blood to the tumor, causing the tumor to die. This procedure has been shown to shrink tumors and allow patients with liver cancer to live longer. This treatment is an established standard of care for patients with liver cancer. When the beads are coated with chemotherapy, the treatment is called “drug-eluting bead transarterial chemoembolization” (deb-TACE).

Nivolumab boosts the immune system’s ability to recognize and kill cancer cells. Nivolumab is approved by the FDA for the treatment of a number of cancers, but not liver cancer. Nivolumab has been tested in liver cancer and has been shown to be safe and cause tumors to shrink. There is some evidence that adding the immunotherapy drug nivolumab to deb-TACE therapy may help make this treatment more effective against liver cancer. In this study, researchers want to see how safe and effective the combination of nivolumab and deb-TACE is for patients with liver cancer that is limited to the liver. All patients will receive nivolumab intravenously (by vein) every two weeks up to one year after embolization.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have hepatocellular cancer that cannot be successfully treated with surgery or a liver transplant.
  • Patients must have liver cancer limited to the liver.
  • Patients may not have previously received embolization, ablation, or immunotherapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. James Harding at 646-888-4314.

Protocol

17-087

Phase

Pilot

Investigator