Overview
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.
Eligibility
Key Inclusion Criteria:
- Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF)
- Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (UC)
- Must be eligible to receive cisplatin or carboplatin in the investigator's judgment
- Have had no prior systemic chemotherapy for locally advanced or metastatic UC
- Must be able to provide fresh or archival tumor tissues with an associated pathological report.
- Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Adequate organ function before randomization:
Key Exclusion Criteria:
- Received prior therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Any approved anticancer therapy within 28 days before randomization.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Participants with uncontrolled hypercalcemia
- Participants with active autoimmune diseases or history of autoimmune diseases that may relapse
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases
- A known history of HIV infection.
- Prior allogeneic stem cell transplantation or organ transplantation.
- History of severe hypersensitivity reactions to other monoclonal antibodies. 10．History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.