Tislelizumab
Drug200 mg administered Intravenously (IV) as specified in the treatment arm
Other names: BGB-A317
NCT Number: NCT03967977
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Anhui Provincial Hospital, Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
200 mg administered Intravenously (IV) as specified in the treatment arm
Other names: 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
Time frame: From first randomization up to 3.5 years, approximately
Time frame: From first randomization up to 3.5 years, approximately
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
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
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
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
Time frame: From first randomization up to 3.5years, approximately
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 3.5 years, approximately
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.
BeiGene
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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