A Phase 1/2 Study of Combination Drug Treatments for People With Urothelial Carcinoma


Full Title

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With Urothelial Carcinoma (KEYMAKER-U04)


Researchers want to find the best doses of different drugs to use together in people with advanced urothelial cancer. The people in this study have urothelial cancer that metastasized (spread) and has not yet been treated.

If you join this study, you will receive the drug enfortumab vedotin in combination with either pembrolizumab, MK-4280A, or MK-7684A. These drug combinations may help your immune system fight cancer. All of these medications are given intravenously (by vein). You will be randomly assigned to get one of these treatments:

  • MK-4280A (MK-4280 combined with pembrolizumab) plus enfortumab vedotin
  • MK-7684A (MK-7684 combined with pembrolizumab) plus enfortumab vedotin
  • Pembrolizumab plus enfortumab vedotin

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic urothelial cancer.
  • Have not received treatment for metastatic urothelial cancer.
  • Have recovered from the serious side effects of prior treatments before receiving the study drugs.
  • Be age 18 or older.


For more information or to see if you can join this study, please call Dr. Samuel Funt at 646-888-4770.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID