A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D
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.
⁃ The main inclusion criteria include but are not limited to the following:
• 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
• If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load before randomization
• If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization