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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03967977
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

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 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.

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

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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 29, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tislelizumab in combination with chemotherapy
Tislelizumab: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles
Drug: Tislelizumab
200 mg administered Intravenously (IV) as specified in the treatment arm
Other Name: BGB-A317

Drug: Cisplatin
70 mg/m2 administered IV as specified in the treatment arm

Drug: Gemcitabine Hydrochloride
1000 mg/m2 administered IV as specified in the treatment arm

Drug: Carboplatin
Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm

Placebo Comparator: Placebo in combination with chemotherapy
Placebo: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles
Drug: Placebo
Tislelizumab placebo to match

Drug: Cisplatin
70 mg/m2 administered IV as specified in the treatment arm

Drug: Gemcitabine Hydrochloride
1000 mg/m2 administered IV as specified in the treatment arm

Drug: Carboplatin
Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm




Primary Outcome Measures :
  1. Overall survival (OS) in the Intent to Treat (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 participants who had Complete Response (CR) or Partial Response (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 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

  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 participants 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Key Inclusion Criteria:

  1. Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF)
  2. Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (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. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  8. Adequate organ function before randomization:

Key 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. Participants with uncontrolled hypercalcemia
  5. Participants 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03967977


Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Dingwei Ye, MD Fudan University
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03967977    
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: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
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