Study of Tislelizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer

Key Inclusion Criteria

• Participants with histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium
• Disease progression during or following treatment with at least one platinum-containing regimen for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
• Participants must submit archival tumor tissue for determination of program death ligand-1 (PD-L1) expression and other biomarker analyses. PD-L1 expression will be assessed centrally, and participants who are tested as PD-L1 high are eligible.
• Participants must have at least one measurable lesion as defined per RECIST version 1.1 assessed by the investigator
• Male or female, aged ≥18 years on day of signing informed consent
• Participants have voluntarily agreed to participate by giving written informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
• Life expectancy ≥12 weeks
• Participant must have adequate organ function as indicated by the following screening laboratory values obtained within 7 days prior to the first study treatment
• Absolute neutrophil count (ANC) ≥1.5×109/L
• Platelets ≥100×109/L
• Hemoglobin ≥9 g/dL or ≥5.6 mmol /L (Note: Criteria must be met without a transfusion within 14 days of obtaining the sample)
• Calculated creatinine clearance ≥ 30 milliliter (mL)/min (Cockcroft-Gault formula, see Appendix 5)
• Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (total bilirubin must be 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
• Has history of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies
• With severe chronic or active infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug.
• With uncontrollable pleural effusion, pericardial effusion or ascites requiring pleurocentesis or abdominal tapping less than 4 weeks
• Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
• Known history of Human Immunodeficiency Virus (HIV)
• Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carrier with HBV deoxyribonucleic acid (DNA) ≥500 IU/mL (or 2.5 × 103 cps/mL), or active hepatitis C should be excluded. Participant with inactive hepatitis B surface antigen (HBsAg) carrier, active HBV infection with sustained anti-HBV suppression (HBV DNA <500 IU/mL or 2.5 × 103 cps/mL) and participants whose hepatitis C has been cured (hepatitis C virus [HCV] ribonucleic acid [RNA] is lower than detection limit) can be enrolled
• Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events (AEs)
• Prior chemotherapy, radiotherapy, immunotherapy or any investigational therapies (including Chinese herbal medicine and Chinese patent medicines) used to control cancer within 2 weeks of Cycle 1 Day 1. AEs associated with these therapies must be Grade 0-1, baseline or stabilized (except for alopecia)
• Prior allogeneic stem cell or solid organ transplant
• Administration of a live or attenuated vaccine within 4 weeks prior to study drug administration
• Major surgical procedure other than for diagnosis within 28 days prior to study drug administration

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.