Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
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
2 other identifiers
interventional
420
2 countries
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2019
Longer than P75 for phase_3
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedStudy Start
First participant enrolled
May 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 21, 2027
April 23, 2026
April 1, 2026
8.1 years
May 23, 2019
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS) in the Intent to Treat (ITT) set
From first randomization up to 3.5 years, approximately
Secondary Outcomes (7)
Overall response rate (ORR) per RECIST v1.1 in ITT
From first randomization up to 3.5 years, approximately
Duration of response (DOR)
From first randomization up to 3.5 years, approximately
Progression-free survival (PFS)
From first randomization up to 3.5 years, approximately
Overall survival rate at 1 and 2 years for each treatment arm
From first randomization up to 3.5 years, approximately
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30)
From first randomization up to 3.5 years, approximately
- +2 more secondary outcomes
Study Arms (2)
Tislelizumab in combination with chemotherapy
ACTIVE COMPARATORTislelizumab: 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 in combination with chemotherapy
PLACEBO COMPARATORPlacebo: 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
Interventions
200 mg administered Intravenously (IV) as specified in the treatment arm
70 mg/m2 administered IV as specified in the treatment arm
1000 mg/m2 administered IV as specified in the treatment arm
Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- 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:
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (46)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Fifth Medical Center of Pla General Hospital
Beijing, Beijing Municipality, 100071, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Chinese Pla General Hospital
Beijing, Beijing Municipality, 100853, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Jiangsu Province Cancer Hospital
Nanjing, Jiangsu, 210008, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
The Second Affiliated Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300000, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 310014, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
The First Provincial Wenzhou Hospital of Zhejiang
Wenzhou, Zhejiang, 325000, China
Keelung Chang Gung Memorial Hospital and Loves Lake Branch
Anle Dist, 204, Taiwan
Taipei Veterans General Hospital
Beitou Dist, 11217, Taiwan
Linkou Chang Gung Memorial Hospital
Guishan Dist, 33305, Taiwan
National Cheng Kung University Hospital
North Dist, 704, Taiwan
National Taiwan University Hospital
Zhongzheng Dist, 100225, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dingwei Ye, MD
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 30, 2019
Study Start
May 29, 2019
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
October 21, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.