NCT03967977

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg administered Intravenously (IV) as specified in the treatment arm
DRUG	Placebo	Tislelizumab placebo to match
DRUG	Cisplatin	70 mg/m2 administered IV as specified in the treatment arm
DRUG	Gemcitabine Hydrochloride	1000 mg/m2 administered IV as specified in the treatment arm
DRUG	Carboplatin	Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm

Timeline

• Start date: 2019-05-29
• Primary completion: 2027-06-30
• Completion: 2027-10-21
• First posted: 2019-05-30
• Last updated: 2026-04-17

Locations

46 sites across 2 countries: China, Taiwan