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A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
590
Start Date
2026-04-15
Completion Date
2030-04-23
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab tirumotecan
IV infusion
Vinflunine
IV infusion
Docetaxel
IV infusion
Paclitaxel
IV infusion
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).
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.
Locations (2)
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
Cincinnati, Ohio, United States
Thompson Cancer Survival Center ( Site 0803)
Knoxville, Tennessee, United States