Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab.
The goals of this study are to learn about:
* The safety of the study treatment when given with standard treatment and if people tolerate it * The number of people who have the cancer respond (cancer gets smaller or goes away) with the new study treatment when given with standard treatment.
Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic
Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy)
Must not have received prior systemic therapy for locally advanced or metastatic UC
If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
Has active keratitis or corneal ulcerations
Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention