Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

To join this study, you must have advanced urothelial cancer (bladder cancer or related cancers in the urinary system) that has spread and hasn't had chemotherapy before. Your doctor will need to confirm this with tests.

It's important that your cancer cells are available for testing to check for a specific marker called PD-L1. This test needs to be done before you're considered for the study. You might be able to take part whether or not you can have a specific chemotherapy drug called cisplatin, which is decided based on things like your kidney function, hearing, nerve health, and heart condition.

There are also some reasons why you wouldn't be able to join. For example, if you've already had certain types of immune-boosting cancer treatments, or if you have specific serious autoimmune conditions like lupus or rheumatoid arthritis that are active. Brain tumours or spinal cord problems would also prevent you from joining unless they are stable and you're not taking steroids for them.

If you decide to join this study, you will be randomly assigned to one of three treatment groups. This means you could receive MEDI4736 alone, MEDI4736 with tremelimumab, or standard chemotherapy. You will receive these treatments regularly, as guided by the study doctors. This will involve regular visits to the hospital for your treatment and check-ups.

During your visits, the study team will carry out various assessments. These include blood tests, scans, and other medical checks to see how well the treatment is working and to monitor for any side effects. You will continue to have treatment until your cancer gets worse, side effects become too bothersome, or you choose to stop for any reason. After stopping treatment, doctors will keep in touch and monitor your health for up to two years to see how you are doing in the long term.