Stellar-002: XL-092 (Kidney, Bladder, and Prostate Cancer)
What is the Purpose of this Study?
- The study drug on its own
- The study drug + nivolumab
- The study drug + nivolumab and ipilimumab
- Nivolumab and ipilimumab on their own without the study drug
The study drug is a pill that you take once a day. Nivolumab and ipilimumab are intravenous (IV) infusions given in the clinic every 3 weeks.
No matter what study group you are assigned to, you will also:
- Have blood draws and give urine samples
- Have ECGs, which is a test to measure your heart function
- Have imaging tests (CT and/or MRI, and possibly bone and brain scans)
- Provide a tumor tissue sample
Who Can Participate in this Study?
Adults ages 18+ who match 1 of the following descriptions:
- Are diagnosed with advanced or metastatic kidney cancer with a clear cell component and have not received prior anticancer drugs; OR
- Are diagnosed with advanced or metastatic kidney cancer with a clear cell component that progressed after receiving first-line anticancer drugs; OR
- Are diagnosed with metastatic prostate cancer that progressed after receiving hormone therapy; OR
- Are diagnosed with advanced or metastatic bladder cancer that progressed after chemotherapy and who have not received more than 1 previous anticancer therapy; OR
- Are diagnosed with advanced or metastatic bladder cancer that progressed after PD-1/L1 therapy and who have not received more than 2 previous anticancer therapies; OR
- Are diagnosed with advanced or metastatic non-clear cell kidney cancer who have not received previous anticancer drugs
For more information about who can join this study, please contact the study team at catrin.davies@duke.edu.
What is Involved?
We are doing this study to find out if an investigational drug called XL092 (the study drug) is a safe and effective option on its own or in combination with other anticancer drugs.
