CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 420 enrolled / 420 target
Drug / intervention
Tislelizumab +4 moredrug
Likely dose
Tislelizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03967977
NCT03967977Phase 3ActiveMonitor (4.9/mo)
CompareCT.gov

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

BeiGene·interventional·Posted May 30, 2019·Updated Jun 22, 2026

In Brief

A Phase 3 clinical trial evaluating Tislelizumab, Placebo, and 3 other interventions for Urothelial Carcinoma. Active but no longer recruiting, targeting 420 participants across 46 sites in 2 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma
CountriesChina, Taiwan
Collaborators--

Timeline

Phase 3Active
202020212022202320242025202620272028
First PostedMay 30, 2019
Enrollment StartMay 29, 2019
Primary CompletionJun 30, 2027
Study CompletionOct 21, 2027
TodayJul 1, 2026
Enrollment to primary: 8.1 yearsPosted 7.1 years agoPrimary completion in 12 months

Arms & Interventions

Tislelizumab in combination with chemotherapyactive_comparator

Tislelizumab: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles

Drug: TislelizumabDrug: CisplatinDrug: Gemcitabine HydrochlorideDrug: Carboplatin
Placebo in combination with chemotherapyplacebo_comparator

Placebo: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles

Drug: PlaceboDrug: CisplatinDrug: Gemcitabine HydrochlorideDrug: Carboplatin

Interventions

Tislelizumabdrug

200 mg administered Intravenously (IV) as specified in the treatment arm

Placebodrug

Tislelizumab placebo to match

Cisplatindrug

70 mg/m2 administered IV as specified in the treatment arm

Gemcitabine Hydrochloridedrug

1000 mg/m2 administered IV as specified in the treatment arm

Carboplatindrug

Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm