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Locally Advanced or Metastatic Urothelial Bladder CancerPhase 2NCT04004221

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

A Phase 2 study testing Tislelizumab in people with Locally Advanced or Metastatic Urothelial Bladder Cancer, run by BeiGene at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody BGB-A317 in participants with PD-L1+, locally advanced or metastatic Urothelial Bladder Cancer (UBC) who have progressed during or following a platinum-containing regimen Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
27 sitesin 2 countries
Study dates
16 Jun 2017to 11 Mar 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium
  • Disease progression during or following treatment with at least one platinum-containing regimen for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
  • Participants must submit archival tumor tissue for determination of program death ligand-1 (PD-L1) expression and other biomarker analyses. PD-L1 expression will be assessed centrally, and participants who are tested as PD-L1 high are eligible.
  • Participants must have at least one measurable lesion as defined per RECIST version 1.1 assessed by the investigator
  • Male or female, aged ≥18 years on day of signing informed consent
  • Participants have voluntarily agreed to participate by giving written informed consent
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  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • Life expectancy ≥12 weeks
  • Participant must have adequate organ function as indicated by the following screening laboratory values obtained within 7 days prior to the first study treatment
  • Absolute neutrophil count (ANC) ≥1.5×109/L
  • Platelets ≥100×109/L
  • Hemoglobin ≥9 g/dL or ≥5.6 mmol /L (Note: Criteria must be met without a transfusion within 14 days of obtaining the sample)
  • Calculated creatinine clearance ≥ 30 milliliter (mL)/min (Cockcroft-Gault formula, see Appendix 5)
  • Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (total bilirubin must be <4 X ULN for participants with Gilbert's syndrome)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for participants with liver metastases
  • Female participants are eligible to enter and participate in the study if they are of:
  • Non-childbearing potential (ie, physiologically incapable of becoming pregnant), including any female who i) Has had a hysterectomy ii) Has had a bilateral oophorectomy (ovariectomy) iii) Has had a bilateral tubal ligation iv) Is post menopausal (total cessation of menses for ≥1 year)
  • Childbearing potential, has a negative serum pregnancy test at screening (within 7 days before the first investigational product administration), not be breast feeding, and agree to remain abstinent (refrain from heterosexual intercourse) or uses adequate contraceptive methods that result in a failure rate of <1% per year before study entry and throughout the study until 120 days after the last investigational product administration
  • Male participants are eligible to participate in the study if they are vasectomized or agree to use contraception during the study treatment period and for at least 120 days after the last dose of study drug

Who cannot join

  • History of severe hypersensitivity reactions to other humanized monoclonal antibodies
  • Prior active malignancy within 2 years prior to Cycle 1 Day 1.
  • Prior therapies targeting PD-1 or PD-L1.
  • Active brain or leptomeningeal metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.
  • Participants with active autoimmune diseases or history of autoimmune diseases that may relapse should be excluded.
  • Participants should be excluded if they have conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
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  • Has history of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies
  • With severe chronic or active infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug.
  • With uncontrollable pleural effusion, pericardial effusion or ascites requiring pleurocentesis or abdominal tapping less than 4 weeks
  • Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
  • Known history of Human Immunodeficiency Virus (HIV)
  • Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carrier with HBV deoxyribonucleic acid (DNA) ≥500 IU/mL (or 2.5 × 103 cps/mL), or active hepatitis C should be excluded. Participant with inactive hepatitis B surface antigen (HBsAg) carrier, active HBV infection with sustained anti-HBV suppression (HBV DNA <500 IU/mL or 2.5 × 103 cps/mL) and participants whose hepatitis C has been cured (hepatitis C virus [HCV] ribonucleic acid [RNA] is lower than detection limit) can be enrolled
  • Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events (AEs)
  • Prior chemotherapy, radiotherapy, immunotherapy or any investigational therapies (including Chinese herbal medicine and Chinese patent medicines) used to control cancer within 2 weeks of Cycle 1 Day 1. AEs associated with these therapies must be Grade 0-1, baseline or stabilized (except for alopecia)
  • Prior allogeneic stem cell or solid organ transplant
  • Administration of a live or attenuated vaccine within 4 weeks prior to study drug administration
  • Major surgical procedure other than for diagnosis within 28 days prior to study drug administration
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

China24 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

    Guangzhou, Guangdong, 510000

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi, 330029

  • Jiangsu Province Cancer Hospital

    Nanjing, Jiangsu, 210008

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • The Second Affiliated Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000

  • The First Provincial Wenzhou Hospital of Zhejiang

    Wenzhou, Zhejiang, 325000

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

Other trials in China

South Korea3 sites

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 06273

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

About this study

Official title: A Single-Arm, Multicenter Phase 2 Study of BGB-A317 in Patients With Previously Treated PD-L1+ Locally Advanced or Metastatic Urothelial Bladder Cancer

This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody BGB-A317 in participants with PD-L1+, locally advanced or metastatic Urothelial Bladder Cancer (UBC) who have progressed during or following a platinum-containing regimen

Being tested
Tislelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317

    200mg intravenously (IV) every 3 weeks (Q3W)

Study groups in NCT04004221
Study groupRoleWhat they receive
TislelizumabExperimental200mg intravenously (IV) every 3 weeks(Q3W)
Receives: Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)

    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

    Measured: From the date of first dose up to approximately 2 years and 2 months

Secondary outcomes (9)

  1. Duration of Response (DOR) as Assessed by IRC

    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

    Measured: From the date of first dose up to approximately 2 years and 2 months

  2. Progression-Free Survival (PFS) as Assessed by IRC

    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

    Measured: From the date of first dose up to approximately 2 years and 2 months

  3. Disease Control Rate (DCR) as Assessed by IRC

    DCR is defined as the percentage of participants who achieve CR, PR and stable disease (SD) assessed by IRC using RECIST version 1.1

    Measured: From the date of first dose up to approximately 2 years and 2 months

  4. Overall Survival (OS)

    OS - defined as the time from the date of first dose of study drug until the date of death from any cause

    Measured: From the date of first dose up to approximately 2 years and 2 months

  5. ORR as Assessed by the Investigators

    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)

    Measured: From the date of first dose up to approximately 2 years and 2 months

  6. DOR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST

    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

    Measured: From the date of first dose up to approximately 2 years and 2 months

  7. PFS as Assessed by Investigators Per RECIST Version 1.1 and irRECIST

    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

    Measured: From the date of first dose up to approximately 2 years and 2 months

  8. DCR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST

    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

    Measured: From the date of first dose up to approximately 2 years and 2 months

  9. Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    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.

    Measured: From the date of first dose until End of Study (approximately 3 years and 9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2019
  2. Study start16 Jun 2017
  3. Primary completion16 Sep 2019
  4. Study completion11 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04004221
Sponsor's protocol ID
BGB-A317-204
Other IDs
CTR20170071
Status last verified
Oct 2024
First submitted
28 Jun 2019
Last updated
26 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon request, and subject to certain criteria, conditions, and exceptions, BeiGene will provide access to individual de-identified participant data from BeiGene-sponsored global interventional clinical studies conducted for medicines for indications that have been approved or in programmes that have been terminated. BeiGene will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data requests can be submitted to medicalinformation@beigene.com.

Publications

  • Ye D, Liu J, Zhou A, Zou Q, Li H, Fu C, Hu H, Huang J, Zhu S, Jin J, Ma L, Guo J, Xiao J, Park SH, Zhang D, Qiu X, Bao Y, Zhang L, Shen W, Bi F. Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma. Cancer Sci. 2021 Jan;112(1):305-313. doi: 10.1111/cas.14681. Epub 2020 Nov 6.

    PubMed 33047430

  • Ye D, Desai J, Shi J, Liu SM, Shen W, Liu T, Shi Y, Wang D, Liang L, Yang S, Ma X, Jin W, Zhang P, Huang R, Shen Z, Zhang Y, Wu YL. Co-enrichment of CD8-positive T cells and macrophages is associated with clinical benefit of tislelizumab in solid tumors. Biomark Res. 2023 Mar 7;11(1):25. doi: 10.1186/s40364-023-00465-w.

    PubMed 36879284

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab in people with Locally Advanced or Metastatic Urothelial Bladder Cancer, run by BeiGene at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC) (time frame: From the date of first dose up to approximately 2 years and 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04004221, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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