(Protocol EA8192) “A Phase II/III Trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy”

Summary

The purpose of this study is to compare a usual treatment alone to using MEDI4736 (durvalumab) plus the usual treatment. The study approach could shrink your cancer. But, it could also cause side effects, which are described in the risks section below. MEDI4736 (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.

Description

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.