Clinical Trial

Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-18
Trial Details
NCT Number NCT03967977
Lead Sponsor BeiGene
Conditions Urothelial Carcinoma
Enrollment 420 participants
Start Date 2019-05-29
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-10-21 (estimated)
Updated on ClinicalTrials.gov 2026-06-22