Full Title
A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination with Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma (RELATIVITY-106)Purpose
The purpose of this study is to evaluate the safety and effectiveness of adding relatlimab to nivolumab and bevacizumab for people with previously untreated advanced hepatocellular carcinoma (liver cancer). Relatlimab works by attaching to and blocking a protein called LAG-3, which shuts down parts of the immune system. Scientists believe that this mechanism might be one way that cancers use to escape detection by the immune system.
Nivolumab blocks a similar protein called PD-1. Both drugs work to boost the power of the immune system to find and destroy cancer cells. Bevacizumab inhibits the development of blood vessels that tumors need to grow and spread.
This study has two phases. In phase 1, doctors will determine the best doses of relatlimab, nivolumab, and bevacizumab. These doses will be used in phase 2, where participants will be randomly assigned to receive nivolumab and bevacizumab with either relatlimab or a placebo (inactive drug). All of the medications are given intravenously (by vein).
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have advanced hepatoceullular carcinoma that has not yet been treated with anticancer medications.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 and older.
Contact
For more information and to inquire about eligibility for this study, please contact Dr. James Harding at 646-888-4314.