Summary

This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.

Description

The usual approach for patients who are not in a study is treatment with immunotherapy (pembrolizumab) which allows the body’s immune system to work against tumor cells. This is the FDA-approved treatment for advanced kidney cancer.  Immunotherapy after surgery to remove kidney cancer   has been shown to prevent cancer from coming back and help patients live longer. While medications that target blood vessels (tivozanib) are approved by the FDA to be given after surgery alone to remove all cancer, these drugs alone have not been shown to help patients live longer.
 
The purpose of this study is to compare the usual treatment alone to using tivozanib plus the usual treatment. The addition of tivozanib to the usual treatment could prevent it from returning.

Principal Investigator

Kok Hoe Chan

Research Contact

Lisa Luikart  lisa.luikart@vandaliahealth.org

304-388-9944

Sex

All

Age

18+

NCT Number

NCT06661720

IRB Number

25-1197

Phase(s)

3

Link

Link to this trial on ClinicalTrials.gov