A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Summary
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body. The usual treatment for MIBC is surgery to remove the bladder but some people choose to have other treatments, such as chemoradiotherapy (CRT), instead of surgery so they can keep their bladder. Researchers want to know if giving 2 trial treatments with CRT can treat MIBC. One trial treatment is called sacituzumab tirumotecan (sac-TMT) and the other trial treatment is called subcutaneous (SC) pembrolizumab (or pembrolizumab and berahyaluronidase alfa). The main goal of this trial is to learn if participants who receive sac-TMT, SC pembrolizumab, and CRT live longer without their cancer growing, spreading, or coming back compared to those who receive CRT alone.
Timeline
- Start
- 2026-10-20
- Primary completion
- 2031-11-17
- Completion
- 2036-09-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab and Berahyaluronidase alfa | Unknown | 790 mg | Subcutaneous |
| Subject | Sac-TMT | Unknown | 4 mg/kg | Intravenous |
| Background | Acetaminophen | Small molecule | — | — |
| Background | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Background | Cisplatin | Other / unclassified | 35 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | — | — |
| Background | Gemcitabine | Small molecule | 27 mg/m2 | Intravenous |
| Background | MMC | Unknown | 12 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |