Study on Two Dosing Schedules of Atezolizumab with Gemcitabine and Cisplatin for First-Line Treatment of Metastatic Bladder Cancer

Inclusion Criteria

• Diagnosed with urothelial carcinoma of the bladder, ureter, urethra, or renal pelvis, with a predominant urothelial component.
• Cancer must be locally advanced or metastatic.
• Age 18 years or older.
• Expected to live at least 12 more weeks.
• Must have measurable cancer and a site that can be biopsied.
• Agree to undergo two biopsies during treatment.
• Must have enough tumor tissue for PD-L1 testing.
• Adequate blood and organ function based on specific lab results.
• Women and men of childbearing potential must use effective contraception during and for 5 months after treatment.
• ECOG performance status of 0 or 1.
• Ability to comply with study requirements.

Exclusion Criteria

• Previous chemotherapy or immunotherapy for metastatic urothelial cancer, except certain prior treatments.
• Recent anticancer therapy, except specific allowed treatments.
• Significant liver disease or bone marrow disorders.
• Active or untreated brain metastases.
• Pregnancy or breastfeeding.
• Severe heart disease or nerve damage.
• Allergies to certain cell products or antibodies.
• History of autoimmune diseases, with some exceptions.
• Severe lung diseases or infections.
• Recent major surgery or live vaccines.
• Other cancers within the last 5 years, with some exceptions.
• Previous treatment with certain immune therapies.
• Use of certain medications or treatments before the study.