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Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Patients With Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT03967977
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
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 patients with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Tislelizumab Cisplatin for Injection Carboplatin InjectionGemcitabine Gemcitabine Hydrochloride for Injection Drug: Cisplatin for Injection Carboplatin InjectionGemcitabine Gemcitabine Hydrochloride for Injection Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Tislelizumab in combination with chemotherapy Drug: Tislelizumab Cisplatin for Injection Carboplatin InjectionGemcitabine Gemcitabine Hydrochloride for Injection

Tislelizumab:200 mg, Intravenous, Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: 70 mg/m2, Intravenous, Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: AUC 4.5, Intravenous, Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: 1000 mg/m2, Intravenous, Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles

(Do not repeat information already included in arm/group descriptions.)
Placebo Comparator: Placebo in combination with chemotherapy Drug: Cisplatin for Injection Carboplatin InjectionGemcitabine Gemcitabine Hydrochloride for Injection

Placebo:200 mg, Intravenous, Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: 70 mg/m2, Intravenous, Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: AUC 4.5, Intravenous, Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: 1000 mg/m2, Intravenous, Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles

(Do not repeat information already included in arm/group descriptions.)


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) in the ITT set [ Time Frame: From first randomization up to 3.5 years, approximately ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) per RECIST v1.1 in ITT [ Time Frame: From first randomization up to 3.5 years, approximately ]
    the proportion of patients who had CR or PR as assessed by the investigator per RECIST v1.1 in the ITT Analysis Set

  2. Duration of response (DOR) [ Time Frame: From first randomization up to 3.5 years, approximately ]
    the time from the first occurrence of a documented objective response to documented PD, or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set

  3. Progression-free survival (PFS) [ 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

  4. Overall survival rate at 1 and 2 years for each treatment arm [ Time Frame: From first randomization up to 3.5 years, approximately ]
    the proportion of OS patients at 1 year and 2 years from randomization in the ITT Analysis Set

  5. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30) [ Time Frame: From first randomization up to 3.5 years, approximately ]
    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.

  6. Incidence and severity of treatment-emergent adverse events (AEs) [ 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

  7. Change from baseline in European Quality of Life 5-Dimension, 5-Level version (EQ-5D-5L) [ 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged 18 to 75 years on the day of signing the ICF
  2. Histologically confirmed, inoperable, locally advanced, or metastatic UC
  3. Must be eligible to receive cisplatin or carboplatin in the investigator's judgment
  4. Have had no prior systemic chemotherapy for locally advanced or metastatic UC
  5. Must be able to provide fresh or archival tumor tissues with an associated pathological report.
  6. Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1.
  7. ECOG Performance Status 0 or 1.
  8. Adequate organ function before randomization:

Exclusion Criteria:

  1. Received prior therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  2. Any approved anticancer therapy within 28 days before randomization.
  3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  4. patients with uncontrolled hypercalcemia
  5. patents with active autoimmune diseases or history of autoimmune diseases that may relapse
  6. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases
  7. A known history of HIV infection.
  8. Prior allogeneic stem cell transplantation or organ transplantation.
  9. History of severe hypersensitivity reactions to other monoclonal antibodies. 10．History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03967977


Contacts
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Contact: Ying Zhao, COM 1-877-828-5568 ClinicalTrials@beigene.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Yong Yang    +86-10-8819 6393    yoya_urology@sina.com   
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Contact: Hanzhong Li, Bachelor    +86-10-69156031    lihanzhong@gmail.com   
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Dingwei Ye Fudan University
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03967977     History of Changes
Other Study ID Numbers: BGB-A317-310
CTR20190543 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Carboplatin
Antineoplastic Agents
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs