Study on Different Immunotherapies for Untreated Advanced Urothelial Cancer

Inclusion Criteria

• Must have a performance status score of 2 or less, indicating full activity or some restriction in strenuous activities.
• Have a confirmed diagnosis of advanced urothelial cancer, including certain subtypes, as long as there is a urothelial component in the tumor.
• Cannot receive platinum-based chemotherapy.
• Have not received chemotherapy for advanced or recurrent urothelial cancer.
• Have at least one tumor that can be measured using standard criteria.
• Provide a leftover tumor sample for testing.
• Have good blood and organ function.
• Test negative for hepatitis B and C.
• Have adequate heart function.

Exclusion Criteria

• Pregnant or breastfeeding women.
• Have very low kidney function (GFR less than 15 mL/min/1.73 m2).
• Have untreated or worsening cancer spread to the brain.
• Have a history of cancer spread to the membranes around the brain and spinal cord.
• Have uncontrolled pain from the tumor.
• Have uncontrolled fluid buildup around the lungs, heart, or abdomen.
• Have high calcium levels in the blood that are uncontrolled.
• Have active or past autoimmune diseases or immune deficiencies.
• Have certain lung diseases or active lung inflammation.
• Have active tuberculosis or Epstein-Barr virus.
• Have had significant heart or blood vessel disease in the past 3 months.
• Have had major surgery within 4 weeks before starting the study or need major surgery during the study.
• Have had another type of cancer within the past 2 years, except for certain low-risk cancers.
• Have had a severe infection within 4 weeks before starting the study.
• Have taken antibiotics for treatment within 2 weeks before starting the study, except for preventive or specific treatments.
• Have had a stem cell or organ transplant.
• Have received a live vaccine within 4 weeks before starting the study or plan to receive one during the study.
• Are currently on antiviral therapy for hepatitis B.
• Have received any cancer treatment within 3 weeks before starting the study.
• Have received investigational therapy within 4 weeks or 5 drug-elimination half-lives before starting the study.
• Have had previous treatment with certain immune therapies or agents.
• Have taken immune-stimulating or immune-suppressing medications within a specified time before starting the study.
• Have a history of severe allergic reactions to certain antibodies or proteins.