Urothelial Cancer Clinical Trials

⁃ The main inclusion criteria include but are not limited to the following:

• Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment

• Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator

• Has received treatment with anti-programmed cell death \[ligand\] 1 (anti-PD-\[L\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)

• Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry

• Has received a maximum of 3 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