Clinical Trials Search at Vanderbilt-Ingram Cancer Center

This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are immunotherapies which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a targeted therapy specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumors blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.

This is an open-label phase II study assessing the activity of cabozantinib combined with
atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are
ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals
21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus
cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of
treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or
progressive disease by RECIST v1.1 or withdraw consent.