A Phase 3 interventional study of Tislelizumab and Placebo in Urothelial Carcinoma, sponsored by BeiGene. Active, not recruiting at 46 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by BeiGene · Phase 3, Interventional, and Treatment
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.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's enrollment of 420 is above the median of 49 across 549 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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: Tislelizumab · Drug: Cisplatin · Drug: Gemcitabine Hydrochloride · Drug: Carboplatin
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: Placebo · Drug: Cisplatin · Drug: Gemcitabine Hydrochloride · Drug: Carboplatin
200 mg administered Intravenously (IV) as specified in the treatment arm
Also known as: BGB-A317
Tislelizumab placebo to match
70 mg/m2 administered IV as specified in the treatment arm
1000 mg/m2 administered IV as specified in the treatment arm
Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm
Overall survival (OS) in the Intent to Treat (ITT) set
Time frame: From first randomization up to 3.5 years, approximately
Overall response rate (ORR) per RECIST v1.1 in ITT
the proportion of participants who had Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST v1.1 in the ITT Analysis Set
Time frame: From first randomization up to 3.5 years, approximately
Duration of response (DOR)
the time from the first occurrence of a documented objective response to documented Progressive Disease (PD), or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set
Time frame: From first randomization up to 3.5 years, approximately
Progression-free survival (PFS)
the time from randomization to the first objectively documented PD, or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set
Time frame: From first randomization up to 3.5 years, approximately
Overall survival rate at 1 and 2 years for each treatment arm
the proportion of OS participants at 1 year and 2 years from randomization in the ITT Analysis Set
Time frame: From first randomization up to 3.5 years, approximately
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30)
1\) to assess overall health status/Quality of Life with 2 questions which are with range from minimum score 1 as worse outcome and maximum score 7 as higher values represent a better 2) to assess quality of life with 28 questions about Physical functioning, emotional functioning, social functioning etc. which are with range from minimum scores 1 representing as better to maximum scores 4 as worse outcome.
Time frame: From first randomization up to 3.5 years, approximately
Incidence and severity of treatment-emergent adverse events (AEs)
Incidence and severity of treatment-emergent adverse events (AEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)v5.0
Time frame: From first randomization up to 3.5years, approximately
Change from baseline in European Quality of Life 5-Dimension, 5-Level version (EQ-5D-5L)
to assess health status with 1) 5 questions about Mobility, Self-Care, Usual activities, Pain/Discomfort, Anxiety/Depression which are with 5 options. 2) one question about health status at the day of completing the questionnaire with range from minimum score 0 as worse outcome to maximum scores 100 as higher values represent as better.
Time frame: From first randomization up to 3.5 years, approximately
Plan to share: Yes — BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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