Clinical Trials | Testing the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy after surgical removal of the bladder for bladder cancer treatment.

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with bladder cancer who have had their bladder surgically removed for a research study. The purpose of this study is to determine whether a blood test can help us make better decisions about who should get immunotherapy after surgery to remove the bladder for bladder cancer and which immunotherapy treatment is best. New tests have been developed that can detect bladder cancer DNA in the blood which might indicate the presence of bladder cancer cells somewhere in the body. This test, called Signatera, might be able to detect bladder cancer cells in the body even if cancer can’t be seen on a scan of the body. The Signatera blood test is not approved by the FDA in your disease and is investigational. The immunotherapy drug, nivolumab, is already approved by the FDA for use in bladder cancer after surgery to remove the bladder. The immunotherapy drug, relatlimab, is not approved by the FDA for use in bladder cancer after surgery to remove the bladder. The study involves receiving the Signatera test and the investigational drugs (if applicable), as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging of your tumor, and talking to the study doctor. If your Signatera test is positive, you will be randomized by computer into one if the two groups. One group will get a single immunotherapy drug called nivolumab. The other group will get a combination of two immunotherapy drugs called nivolumab and relatlimab. Each immunotherapy drug is given for 1 day as intravenous infusion every 28 days for up to 12 total doses. If your Signatera test is negative, you will be randomized by a computer into one of two groups. One group will get nivolumab as an intravenous infusion for 1 dose every 28 days for up to 12 doses. The other group will not receive immunotherapy after surgery but will instead be closely monitored with repeated Signatera blood tests. While on monitoring (that is, not receiving immunotherapy), if your Signatera test becomes positive, you will start receiving immunotherapy (nivolumab) as an intravenous infusion for 1 dose every 28 days for up to 12 doses. After you finish your immunotherapy treatments, your study doctor will continue to follow your condition and watch you for side effects. You will be asked to come in for standard scans of the body and other blood tests to monitor you for up to 5 years as well as Signatera tests for up to 2 years. The Signatera tests and immunotherapy drugs nivolumab or relatlimab will be provided by the study at no cost to you. All additional procedures required by the study beyond your standard care, including laboratory tests, are provided to you at no charge. Additional information can be found here: https://clinicaltrials.gov/study/NCT05987241 [email protected]