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 you talk with your doctor or clinical trial team member, please have the national 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 trial
Current trial phase
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.
Phase 2
Tests the medicine or vaccine in approximately 100 to 500 participants. In the case of medicines, participants usually have the disease or condition the investigational medicine is designed 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
- Trial start date 07-17-2024
- Estimated primary completion date 07-28-2028
- Estimated trial completion date 07-28-2028
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.