A Phase III Study of Nivolumab Immunotherapy versus Placebo in Patients with Liver Cancer at High Risk of Recurrence after Surgery or Ablation

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Full Title

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation

Purpose

Patients who have a high risk of cancer recurrence after surgery or ablation (application of tumor-killing radio waves) for liver cancer (hepatocellular carcinoma) are only monitored to see if the cancer comes back. There is no therapy available yet to help prevent recurrence of the cancer (what doctors call adjuvant therapy). In this study, nivolumab immunotherapy is being evaluated to see if it can reduce the risk of liver cancer recurrence.

Nivolumab is used to treat several types of cancer, including liver cancer, but its use to reduce liver cancer recurrence is considered investigational. By blocking PD-1, a protein that normally puts the brakes on the immune response, it enhances the power of the immune system to find and destroy cancer cells.

Patients will be randomly assigned to receive nivolumab or a placebo. Nivolumab is given intravenously (by vein).

Eligibility

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

  • Patients must have liver cancer that was removed surgically or ablated.
  • Patients may not have previously received treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other immunotherapy specifically targeting T-cell co-stimulation or checkpoint pathways.
  • 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. Ghassan Abou-Alfa at 646-888-4184.

Protocol

18-439

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators