This study investigates the effects of using an investigational medication along with usual chemotherapy for patients with urothelial carcinoma, which is a type of cancer that affects the urinary tract. The purpose is to see if this combination can improve progression-free survival (PFS) in patients who cannot use cisplatin, a common chemotherapy drug.

Participants will receive a combination of the investigational medication and chemotherapy drugs carboplatin and gemcitabine. Chemotherapy involves using drugs to stop the growth of cancer cells. The study will compare the outcomes of this treatment with previous data to evaluate its effectiveness.

• Who can participate: Adults with confirmed metastatic or advanced urothelial carcinoma, who are unable to use cisplatin, may participate. Key eligibility includes adequate organ function and willingness to use contraception if applicable.
• Study details: Participants will receive chemotherapy with carboplatin and gemcitabine alongside the investigational medication. A placebo is not used in this study.