drugset / Trial / NCT03967977
Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |