Patients with High-Grade Upper Tract Urothelial Cancer

STUDY BASICS

Do you have high-grade upper tract urothelial cancer (UTUC)? You may be eligible for a research study to find out if the Durvalumab approach is better or worse than the usual approach for upper tract urothelial cancer.

STUDY PURPOSE

The purpose of this study is to compare a usual treatment alone to using Durvalumab plus the usual treatment. The study approach could shrink your cancer. But, it could also cause side effects. 

Durvalumab is a type of immunotherapy drug that is already approved by the FDA for use in urothelial cancer. But, most of the time it is not used until platinum- containing chemotherapy, such as cisplatin, stops working for your cancer. 

This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking at two main factors. They will be investigating if the study approach will increase the number of patients whose cancer is shrunk significantly after surgery. They will also be investigating if the study approach increases the number of patients who do not have the cancer come back or get worse. 

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants:

• Are at least 18 years old
• Have upper tract urothelial cancer 

WHAT PARTICIPANTS CAN EXPECT

If you decide to take part in this study, you will either get Durvalumab along with the usual approach cisplatin chemotherapy treatment for your cancer for up to eight weeks followed by surgery within 60 days, or you will get the usual approach cisplatin chemotherapy treatment for up to eight weeks, followed by surgery within 60 days. If your kidneys function below the safe range to receive the usual approach with cisplatin, you will get Durvalumab plus gemcitabine for up to 12 weeks, followed by surgery. 

You will have blood drawn to see if your kidneys are healthy and functioning properly before each treatment. After you finish your treatment, you will complete therapy with standard removal of the kidney and ureter and surrounding lymph nodes. Your doctor and study team will observe you for side effects from the treatments. They will check you every three to six months for 2 years after treatment. After that, they will continue to check you every six months for 3 years. This means you will keep seeing your doctor for 5 years after treatment.