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

Primary Purpose

Urothelial Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Placebo
Cisplatin
Gemcitabine Hydrochloride
Carboplatin
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First HospitalRecruiting
  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting
  • Beijing Cancer HospitalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • Chongqing Cancer HospitalRecruiting
  • Southwest HospitalRecruiting
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • The Second Affiliated Hospital of Fujian Medical UniversityRecruiting
  • The First Affiliated Hospital of Xiamen UniversityRecruiting
  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)Recruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Hubei Cancer HospitalRecruiting
  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Liaoning Cancer Hospital and InstituteRecruiting
  • The Second Affiliated Hospital of Xian Jiaotong UniversityRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Rui Jin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
  • Affiliated Zhongshan Hospital of Fudan UniversityRecruiting
  • Huashan Hospital Affiliated to Fudan UniversityRecruiting
  • Shanghai Changhai HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples HospitalRecruiting
  • The Second Affiliated Hospital of Tianjin Medical UniversityRecruiting
  • Affiliated Cancer Hospital of Xinjiang Medical UniversityRecruiting
  • Yunnan Cancer HospitalRecruiting
  • Zhejiang Provincial Peoples HospitalRecruiting
  • The First Provincial Wenzhou Hospital of ZhejiangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tislelizumab in combination with chemotherapy

Placebo in combination with chemotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival (OS) in the Intent to Treat (ITT) set

Secondary Outcome Measures

Overall response rate (ORR) per RECIST v1.1 in ITT
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
Duration of response (DOR)
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
Progression-free survival (PFS)
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
Overall survival rate at 1 and 2 years for each treatment arm
the proportion of OS participants at 1 year and 2 years from randomization in the ITT Analysis Set
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30)
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.
Incidence and severity of treatment-emergent adverse events (AEs)
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
Change from baseline in European Quality of Life 5-Dimension, 5-Level version (EQ-5D-5L)
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.

Full Information

First Posted
May 23, 2019
Last Updated
August 10, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03967977
Brief Title
Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab in combination with chemotherapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo in combination with chemotherapy
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
200 mg administered Intravenously (IV) as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tislelizumab placebo to match
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
70 mg/m2 administered IV as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Hydrochloride
Intervention Description
1000 mg/m2 administered IV as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm
Primary Outcome Measure Information:
Title
Overall survival (OS) in the Intent to Treat (ITT) set
Time Frame
From first randomization up to 3.5 years, approximately
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) per RECIST v1.1 in ITT
Description
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
Time Frame
From first randomization up to 3.5 years, approximately
Title
Duration of response (DOR)
Description
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
Time Frame
From first randomization up to 3.5 years, approximately
Title
Progression-free survival (PFS)
Description
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
Time Frame
From first randomization up to 3.5 years, approximately
Title
Overall survival rate at 1 and 2 years for each treatment arm
Description
the proportion of OS participants at 1 year and 2 years from randomization in the ITT Analysis Set
Time Frame
From first randomization up to 3.5 years, approximately
Title
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30)
Description
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.
Time Frame
From first randomization up to 3.5 years, approximately
Title
Incidence and severity of treatment-emergent adverse events (AEs)
Description
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
Time Frame
From first randomization up to 3.5years, approximately
Title
Change from baseline in European Quality of Life 5-Dimension, 5-Level version (EQ-5D-5L)
Description
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.
Time Frame
From first randomization up to 3.5 years, approximately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF) Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (UC) Must be eligible to receive cisplatin or carboplatin in the investigator's judgment Have had no prior systemic chemotherapy for locally advanced or metastatic UC Must be able to provide fresh or archival tumor tissues with an associated pathological report. Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. Adequate organ function before randomization: Key Exclusion Criteria: 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. Any approved anticancer therapy within 28 days before randomization. Active leptomeningeal disease or uncontrolled, untreated brain metastasis Participants with uncontrolled hypercalcemia Participants with active autoimmune diseases or history of autoimmune diseases that may relapse History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases A known history of HIV infection. Prior allogeneic stem cell transplantation or organ transplantation. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
+1-877-828-5568
Email
clinicaltrials@beigene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362001
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Liaoning Cancer Hospital and Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Xian Jiaotong University
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610071
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Cancer Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650100
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial Peoples Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
The First Provincial Wenzhou Hospital of Zhejiang
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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