A Phase III Study of Nivolumab Immunotherapy versus Sorafenib as Initial Treatment for Advanced Liver Cancer

Full Title

A Randomized, Multi-center Phase III Study of Nivolumab versus Sorafenib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma

Purpose

Sorafenib is a drug used to treat advanced hepatocellular carcinoma (liver cancer). It works by inhibiting the blood vessels that cancers need to grow and spread. It may help patients live longer, but eventually the cancer often continues to grow. In this study, researchers want to see if the drug nivolumab is more effective than sorafenib for the initial treatment of advanced liver cancer.

Nivolumab is a form of immunotherapy. It boosts the body's immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body's white blood cells. Nivolumab blocks PD-1, enhancing the body's ability to detect and destroy cancer cells. It is approved for treating several types of cancer; its use in this study is considered investigational.

Patients in this study will be randomly assigned to receive sorafenib or nivolumab. Sorafenib is a pill that is taken orally (by mouth), and 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 advanced hepatocellular carcinoma that has not yet been treated with systemic therapy (such as sorafenib or other anticancer drugs). Prior surgery or radiation therapy is allowed, but patients' cancers must have continued to grow despite these treatments.
  • At least 4 weeks must pass between completion of prior therapies and entry into the study.
  • 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 J. Harding at 646-888-4314.

Protocol

16-137

Phase

III

Investigator

Co-Investigators

Locations