drugset / Trial / NCT07419295

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

NCT07419295

Phase 3 Recruiting 590 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-04-23
Primary completion
2029-07-27
Completion
2030-04-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous
Comparator Vinflunine Small molecule 320 mg/m2 Intravenous
Background Acetaminophen Small molecule
Background Dexamethasone Small molecule
Background Pegfilgrastim Protein / enzyme biologic