drugset / Trial / NCT03967977

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

NCT03967977

Phase 3 Active not recruiting 420 enrolled BeiGene
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2019-05-29
Primary completion
2027-06-30
Completion
2027-10-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tislelizumab Monoclonal antibody 200 mg Intravenous
Comparator Carboplatin Small molecule 4.5 unknown Intravenous
Comparator Cisplatin Other / unclassified 70 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications