clinical trial · NCT03967977
Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
BeiGene·phase3·active not recruiting·n = 420
Urothelial CarcinomaTislelizumabPlaceboCisplatinGemcitabine HydrochlorideCarboplatin
brief 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.
started
May 29, 2019
primary completion
Jun 30, 2027
completion
Oct 21, 2027
last updated
Apr 23, 2026
official title
A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of Either Cisplatin or Carboplatin +Gemcitabine + Tislelizumab Compared With Either Cisplatin or Carboplatin + Gemcitabine + Placebo as First-line Treatment for Patients With Locally Advanced or Metastatic Urothelial Carcinoma
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol