This project is being done to find out if Disitamab Vedotin alone or with Pembrolizumab works to treat urothelial cancer and learn more about any side effects.This study uses an experimental drug called Disitamab Vedotin. This means the Food and Drug Administration (FDA) has not approved it for sale in the United States. This study also uses a drug called Pembrolizumab (brand name KEYTRUDA®). Pembrolizumab is approved by the FDA to treat several types of cancer, including cancer of the urinary system, in some people.
Pembrolizumab is approved in the US and other countries for treating many forms of cancer. Thousands of people with cancer have received pembrolizumab, both in clinical trials and from their own doctors.
Disitamab Vedotin sticks to cancer cells that make HER2, and you must also have the kind of cancer cells that make HER2 in order to be in the study. There is the possibility that the test used to identify the HER2 status of your tumor could identify the tumor as being positive for HER2 when, in fact, it is not (false positive). Taking part in this study would be unlikely to benefit you. The laboratory devices which will determine if your cancer cells make and express HER2 are not approved by the FDA and are considered investigational.