A Phase 2 Study of Cabozantinib in Combination with Atezolizumab as Neoadjuvant Treatment for Muscle-Invasive Bladder Cancer (ABATE)

Protocol No
HCRN-GU18-343-ABATE
Phase
II
Summary

The purpose of this study is to see if the combination of Cabozantinib and Atezolizumab can
increase the chances of keeping you cancer free. Researchers will also look at the good and
bad effects of the combination including side effects.

Previous studies have demonstrated that Atezolizumab as a single agent was safe and
associated with meaningful responses for patients with muscle invasive bladder cancer. This
study is being done to see if the combination of Cabozantinib and Atezolizumab can lessen the
chance of your bladder cancer coming back after surgery. Researchers will also look at the
toxicity of this regimen and whether it is better tolerated than other chemotherapy regimens
given before surgery.

Atezolizumab is already approved by the U.S. Food and Drug Administration (FDA) as standard
treatment for advanced urothelial cancer. Cabozantinib is approved for treatment of other types of cancer, but it is investigational in this study. This means that it has not been approved by the
FDA for the treatment of your cancer.

We don't know if this study will help you. Your condition may get better but it could stay the
same or even get worse. We hope the information from this study will help us develop a better
treatment for bladder cancer in the future.

Description
The purpose of this study is to see if the combination of Cabozantinib and Atezolizumab can
increase the chances of keeping you cancer free. Researchers will also look at the good and
bad effects of the combination including side effects.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL