A Phase III Study of Durvalumab and Tremelimumab as Initial Treatment in Patients with Inoperable Liver Cancer (HIMALAYA)

Full Title

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with advanced Hepatocellular Carcinoma (HIMALAYA)

Purpose

This study is comparing the effectiveness of durvalumab given alone or with tremelimumab with standard sorafenib treatment in patients with inoperable hepatocellular carcinoma (liver cancer) who have not yet received treatment. Patients will be randomly assigned to receive one of these therapies:

  • Durvalumab alone
  • Durvalumab plus tremelimumab
  • Sorafenib alone

Durvalumab and tremelimumab are given intravenously (by vein) and sorafenib is taken orally (by mouth).

Eligibility

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

  • Patients must have inoperable liver cancer that has not yet been treated with chemotherapy or any other systemic treatment.
  • Patients may not be eligible for locoregional therapy (such as ablation or embolization) or must have cancer that continued to grow despite locoregional therapy that occurred more than 4 weeks before entering 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. Ghassan Abou-Alfa at 646-888-4184.

Protocol

18-434

Phase

III

Investigator

Co-Investigators