NCT07419295

A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 590 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy. Researchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Sacituzumab tirumotecan	IV infusion
DRUG	Vinflunine	IV infusion
DRUG	Docetaxel	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Rescue medications for sacituzumab tirumotecan	Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).
DRUG	Rescue medications for chemotherapy	Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative.

Timeline

• Start date: 2026-04-15
• Primary completion: 2029-07-27
• Completion: 2030-04-23
• First posted: 2026-02-19
• Last updated: 2026-04-13

Locations

3 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study