Conditions
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
Trial Purpose
This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the safety and preliminary efficacy of sacituzumab tirumotecan plus enfortumab vedotin (EV). Part 2 will be based on Part 1 results and will evaluate the efficacy, pharmacokinetics, and safety of sacituzumab tirumotecan plus EV in combination with pembrolizumab in participants with advanced urothelial carcinoma.
NATIONAL TRIAL REFERENCE NUMBER
NCT06483334
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
About The Study
Trial Phase
Trial Phase 1
Investigational medication is tested for safety on a relatively small group of 20 to 100 volunteers who are usually healthy, but not always. Phase 1 trials may happen in a doctor’s office or a hospital.
Trial Phase 2
In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participants – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Actual study start date July 17, 2024
- Estimated primary completion date July 28, 2028
- Estimated study completion date July 28, 2028
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about