An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

To join this study, you generally need to have had a specific type of surgery for bladder cancer or cancer in the upper urinary tract within the last 120 days. Your cancer must be considered at high risk of coming back after surgery. Importantly, scans must show that you are currently free of cancer after your operation. You will also need to provide a sample of your tumour tissue for further checks.

There are also some reasons why you might not be able to join. For example, if you only had part of your bladder or kidney removed, or if you've already had certain follow-up treatments (like chemotherapy) after your surgery. If you have an active autoimmune disease (where your immune system mistakenly attacks your own body) or certain infections like Hepatitis B or C, you wouldn't be able to take part. Also, if you've been on strong steroid medications or other drugs that suppress your immune system recently, you might not be eligible. This study is for adults aged 18 and over, of any sex.

If you decide to take part in this study, you will first undergo some health checks and scans to make sure you meet all the requirements. Once enrolled, you will be given either Nivolumab or a dummy drug (placebo) regularly. This will involve appointments at the hospital or clinic at set times. During these visits, doctors and nurses will monitor your health, check for any side effects, and conduct further scans or tests to see how you are responding to the treatment.

The exact number and timing of visits will be explained in detail by the study team, but typically clinical trials involve regular check-ups. You'll continue to receive your study medication and have follow-up appointments for a specific period, which could last for several months or even a few years, to track your progress. Even after you stop the study medication, you'll still have follow-up checks to monitor your long-term health and see if the cancer returns.