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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04004221
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : June 3, 2021
Information provided by (Responsible Party):

Brief Summary:
This is 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

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Urothelial Bladder Cancer Drug: Tislelizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 4, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Tislelizumab
200mg intravenously (IV) every 3 weeks(Q3W)
Drug: Tislelizumab
200mg intravenously (IV) every 3 weeks(Q3W)
Other Name: BGB-A317

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 3 Years, approximately ]
    Defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR) assessed by Independent Review Committee (IRC) using RECIST version 1.1

  2. Duration of Response (DOR) [ Time Frame: Up to 3 Years, approximately ]
    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

  3. Progression-Free Survival (PFS) [ Time Frame: Up to 3 Years, approximately ]
    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

  4. Disease Control Rate (DCR) [ Time Frame: Up to 3 Years, approximately ]
    Defined as the proportion of participants who achieve CR, PR and stable disease (SD) assessed by IRC using RECIST version 1.1

  5. Overall Survival (OS) [ Time Frame: Up to 3 Years, approximately ]
    Defined as the time from the date of first dose of study drug until the date of death from any cause

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Participants with histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium
  2. Disease progression during or following treatment with at least one platinum-containing regimen for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
  3. 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.
  4. Participants must have at least one measurable lesion as defined per RECIST version 1.1 assessed by the investigator
  5. Male or female, aged ≥18 years on day of signing informed consent
  6. Participants have voluntarily agreed to participate by giving written informed consent
  7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  8. Life expectancy ≥12 weeks
  9. Participant must have adequate organ function as indicated by the following screening laboratory values obtained within 7 days prior to the first study treatment

    1. Absolute neutrophil count (ANC) ≥1.5×109/L
    2. Platelets ≥100×109/L
    3. Hemoglobin ≥9 g/dL or ≥5.6 mmol /L (Note: Criteria must be met without a transfusion within 14 days of obtaining the sample)
    4. Calculated creatinine clearance ≥ 30 milliliter (mL)/min (Cockcroft-Gault formula, see Appendix 5)
    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)
    6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for participants with liver metastases
  10. Female participants are eligible to enter and participate in the study if they are of:

    1. 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)
    2. 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
  11. 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

Key Exclusion Criteria:

  1. History of severe hypersensitivity reactions to other humanized monoclonal antibodies
  2. Prior active malignancy within 2 years prior to Cycle 1 Day 1.
  3. Prior therapies targeting PD-1 or PD-L1.
  4. Active brain or leptomeningeal metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.
  5. Participants with active autoimmune diseases or history of autoimmune diseases that may relapse should be excluded.
  6. 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.
  7. Has history of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies
  8. 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.
  9. With uncontrollable pleural effusion, pericardial effusion or ascites requiring pleurocentesis or abdominal tapping less than 4 weeks
  10. 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
  11. Known history of Human Immunodeficiency Virus (HIV)
  12. 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
  13. 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)
  14. 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)
  15. Prior allogeneic stem cell or solid organ transplant
  16. Administration of a live or attenuated vaccine within 4 weeks prior to study drug administration
  17. Major surgical procedure other than for diagnosis within 28 days prior to study drug administration

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04004221

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Sponsors and Collaborators
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Principal Investigator: Dingwei Ye, MD Fudan University
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Responsible Party: BeiGene Identifier: NCT04004221    
Other Study ID Numbers: BGB-A317-204
CTR20170071 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases