Trial · NCT04004221

Study of Tislelizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer

NCT04004221, Phase 2, Completed, BeiGene; results first posted 2023-03-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Tislelizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer. Trials, record NCT04004221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04004221

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Tislelizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer
NCT number: NCT04004221
Status: Completed
Phases: Phase 2
Enrollment: 113 participants, actual
Lead sponsor: BeiGene
Conditions: Locally Advanced or Metastatic Urothelial Bladder Cancer
Interventions: Tislelizumab
First posted: 2019-07-01
Last updated: 2024-10-26
Results first posted: 2023-03-16

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)	From the date of first dose up to approximately 2 years and 2 months	ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by Independent Review Committee (IRC) using RECIST version 1.1
Secondary	Duration of Response (DOR) as Assessed by IRC	From the date of first dose up to approximately 2 years and 2 months	DOR - defined as the time from the first determination of a confirmed objective response by IRC according to RECIST version 1.1 until the first documentation of progression or death, whichever comes first
Secondary	Progression-Free Survival (PFS) as Assessed by IRC	From the date of first dose up to approximately 2 years and 2 months	PFS is defined as the time from the date of first dose of study drug to the date of first documentation of disease progression assessed by IRC using RECIST version 1.1 or death, whichever occurs first
Secondary	Disease Control Rate (DCR) as Assessed by IRC	From the date of first dose up to approximately 2 years and 2 months	DCR is defined as the percentage of participants who achieve CR, PR and stable disease (SD) assessed by IRC using RECIST version 1.1
Secondary	Overall Survival (OS)	From the date of first dose up to approximately 2 years and 2 months	OS - defined as the time from the date of first dose of study drug until the date of death from any cause
Secondary	ORR as Assessed by the Investigators	From the date of first dose up to approximately 2 years and 2 months	ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigators per RECIST version 1.1 and immune related RECIST (irRECIST)
Secondary	DOR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	From the date of first dose up to approximately 2 years and 2 months	DOR is defined as the time from the first determination of a confirmed objective response by the investigator according to RECIST version 1.1 and irRECIST until the first documentation of progression or death, whichever comes first
Secondary	PFS as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	From the date of first dose up to approximately 2 years and 2 months	PFS is defined as the time from the date of first dose of study drug to the date of first documentation of disease progression assessed by the investigator according to RECIST version 1.1 and irRECIST until the first documentation of progression or death, whichever comes first
Secondary	DCR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	From the date of first dose up to approximately 2 years and 2 months	DCR is defined as the percentage of participants who achieve CR, PR and stable disease (SD) assessed by investigators per RECIST version 1.1 and irRECIST
Secondary	Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	From the date of first dose until End of Study (approximately 3 years and 9 months)	TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline pre-treatment) on or after the first dose of study drug up to 30 days following study drug .discontinuation. An SAE is any untoward medical occurrence that, at any dose that results in death or is life-threatening.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)	From the date of first dose up to approximately 2 years and 2 months	The Efficacy Evaluable Analysis Set includes all participants who received any dose of tislelizumab and had measurable disease per IRC according to RECIST version 1.1 at baseline	Percentage of participants	NUMBER
SECONDARY	Duration of Response (DOR) as Assessed by IRC	From the date of first dose up to approximately 2 years and 2 months	Efficacy Evaluable Analysis Set	Months	MEDIAN
SECONDARY	Progression-Free Survival (PFS) as Assessed by IRC	From the date of first dose up to approximately 2 years and 2 months	Efficacy Evaluable Set	Months	MEDIAN
SECONDARY	Disease Control Rate (DCR) as Assessed by IRC	From the date of first dose up to approximately 2 years and 2 months	Efficacy Evaluable Set	Percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	From the date of first dose up to approximately 2 years and 2 months	Safety Analysis Set	Months	MEDIAN
SECONDARY	ORR as Assessed by the Investigators	From the date of first dose up to approximately 2 years and 2 months	Efficacy Evaluable Analysis Set	Percentage of participants	NUMBER
SECONDARY	DOR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	From the date of first dose up to approximately 2 years and 2 months	Efficacy Evaluable Analysis Set	Months	MEDIAN
SECONDARY	PFS as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	From the date of first dose up to approximately 2 years and 2 months	Efficacy Evaluable Analysis Set	Months	MEDIAN
SECONDARY	DCR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	From the date of first dose up to approximately 2 years and 2 months	Efficacy Evaluable Analysis Set	Percentage of participants	NUMBER
SECONDARY	Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	From the date of first dose until End of Study (approximately 3 years and 9 months)	Safety Analysis Set	Number of participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)	Tislelizumab		24.0	95% Confidence Interval 16.20 to 33.41	Percentage of participants
Duration of Response (DOR) as Assessed by IRC	Tislelizumab		NA	95% Confidence Interval 8.41 to NA	Months
Progression-Free Survival (PFS) as Assessed by IRC	Tislelizumab		2.1	95% Confidence Interval 2.04 to 3.15	Months
Disease Control Rate (DCR) as Assessed by IRC	Tislelizumab		38.5	95% Confidence Interval 29.09 to 48.51	Percentage of participants
Overall Survival (OS)	Tislelizumab		9.8	95% Confidence Interval 7.46 to 12.48	Months
ORR as Assessed by the Investigators	Tislelizumab	RECIST	24.0	95% Confidence Interval 16.20 to 33.41	Percentage of participants
ORR as Assessed by the Investigators	Tislelizumab	irRECIST	24.0	95% Confidence Interval 16.20 to 33.41	Percentage of participants
DOR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	Tislelizumab	RECIST	NA	95% Confidence Interval 8.31 to NA	Months
DOR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	Tislelizumab	irRECIST	NA	95% Confidence Interval 8.31 to NA	Months
PFS as Assessed by Investigators Per RECIST Version 1.1 and irRECIST	Tislelizumab	RECIST	2.1	95% Confidence Interval 2.07 to 3.58	Months

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tislelizumab	113
Overall Study	COMPLETED	Tislelizumab	0
Overall Study	NOT COMPLETED	Tislelizumab	113

Source ClinicalTrials.gov

Adverse events101

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Tislelizumab	44	113	58
other	Hyperthyroidism	Endocrine disorders	Tislelizumab	6	113	7
other	Hypothyroidism	Endocrine disorders	Tislelizumab	11	113	19
other	Abdominal distension	Gastrointestinal disorders	Tislelizumab	12	113	15
other	Abdominal pain	Gastrointestinal disorders	Tislelizumab	9	113	9
other	Constipation	Gastrointestinal disorders	Tislelizumab	25	113	28
other	Diarrhoea	Gastrointestinal disorders	Tislelizumab	10	113	10
other	Nausea	Gastrointestinal disorders	Tislelizumab	13	113	16
other	Vomiting	Gastrointestinal disorders	Tislelizumab	10	113	11
other	Asthenia	General disorders	Tislelizumab	9	113	12

1 to 10 of 101Source ClinicalTrials.gov

See all 101 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tislelizumab	89	113
Total, other adverse events	Tislelizumab	110	113
Total, serious adverse events	Tislelizumab	49	113

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33047430	RESULT	PubMed
36879284	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04004221

GET https://conductscience.org/api/trials/v1/NCT04004221/events?page=2

API reference For AI assistants