Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

To join this study, you need to have urothelial cancer that has either spread locally or to other parts of your body, and your cancer must show a certain level of a marker called HER2. You can't have had previous widespread treatment for this specific cancer, though some earlier treatments are okay if your cancer returned more than a year later. Your doctor will confirm if you are generally healthy enough for chemotherapy treatments.

There are also some reasons why you might not be able to join. For example, if you've had a very severe allergic reaction to any of the study drugs before, or if you've had certain serious immune-related side effects from similar treatments in the past. If your cancer has spread to your brain or spinal cord, you might not be able to participate, unless it has been stable and treated for a while.

Also, if you have certain existing conditions like actively treated autoimmune diseases (where your immune system attacks your own body) or have recently had treatment that affects your immune system in specific ways, you might not be able to join. Your study doctor will review all your medical history to see if this study is right for you.

If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. You won't get to choose which group you're in.

In one group, you will receive two study drugs: disitamab vedotin every two weeks and pembrolizumab every six weeks. In the other group, called the standard treatment group, you will receive gemcitabine once a week for two weeks, along with either cisplatin or carboplatin once every three weeks.

Before starting, and regularly throughout the study, you'll have various tests, including blood tests, scans, and physical exams, to check how you're doing and how the treatment is working. You'll continue treatment for as long as it's helping and you're not having severe side effects. The total duration of your participation will depend on how your treatment progresses.