An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC

To be able to join this study, you need to be over 18 years old and have been diagnosed with a specific type of bladder cancer (urothelial carcinoma) that has grown into the muscle. You must have had surgery to remove the cancer completely within the last 4 months, and there should be no sign of cancer remaining in your body currently. Your general health should be good, meaning you can carry out most of your daily activities without much trouble, and your organs (like your liver and kidneys) should be working well. You also need to have enough tissue from your surgery available for testing.

There are some reasons why you wouldn't be able to join. For example, if your cancer has certain rare features, or if you've had certain other treatments after your bladder surgery, you might not be suitable. Also, if you have other serious health problems that aren't well controlled, or if you have certain infections like uncontrolled Hepatitis B, C, or HIV, you wouldn't be able to take part. Having another type of cancer (unless it was treated a long time ago and isn't likely to come back) would also exclude you. The study team will review all your medical information carefully to see if this study is right for you.

If you decide to take part in this study, the total time involved is about 6 and a half years from when the first person joins until the last person has their final check-up. The actual treatment you receive will last for up to about one year. During this time, you will be assigned to one of three groups by chance, like flipping a coin. Two groups will receive the new study medications (Dato-DXd and Rilvegostomig), and one group will receive standard treatments currently used for this type of cancer.

Your visits to the clinic will depend on which group you are in. If you are in one of the groups receiving Dato-DXd and Rilvegostomig, you will need to attend appointments every three weeks. If you are in the standard treatment group, you will have visits every two to four weeks, depending on the specific standard treatment you receive. These visits will involve check-ups, blood tests, and scans to monitor your health and how the treatment is working. After the treatment period, there will be follow-up appointments to track your long-term health. The research team will explain all the details of your schedule.