drugset / Trial / NCT06483334
A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2024-07-17
- Primary completion
- 2028-03-31
- Completion
- 2028-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enfortumab Vedotin | Other / unclassified | — | Intravenous |
| Subject | Sacituzumab Tirumotecan | Other / unclassified | — | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |