USO 25019
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 (MK2870-031)
Disease Types: Genitourinary Cancer Research
Eligibility Requirements:
-Has histologically documented locally advanced/metastatic urothelial cancer.Has measurable disease per Response Evaluation Criteria In Solid TumorsHas received treatment with anti-programmed cell death [ligand] 1 (anti-PD-[L]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)Has received a maximum of 2 prior lines of therapy
-Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry
-Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
-Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine)
-Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated
-If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART)
-If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load
-If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
-Has adequate organ function
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