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
Who is this study for? Patients with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy
What treatments are being studied? Tislelizumab+Chemotherapy
Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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:
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Chinese Pla General Hospital
COMPLETED
Beijing
Fifth Medical Center of Pla General Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
COMPLETED
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
ACTIVE_NOT_RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
Xiangya Hospital of Central South University
COMPLETED
Changsha
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
ACTIVE_NOT_RECRUITING
Chengdu
West China Hospital, Sichuan University
RECRUITING
Chengdu
Chongqing Cancer Hospital
RECRUITING
Chongqing
Southwest Hospital
RECRUITING
Chongqing
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Zhejiang Cancer Hospital
COMPLETED
Hangzhou
Zhejiang Provincial Peoples Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
ACTIVE_NOT_RECRUITING
Harbin
Anhui Provincial Hospital
ACTIVE_NOT_RECRUITING
Hefei
Yunnan Cancer Hospital
ACTIVE_NOT_RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University Branch Donghu
ACTIVE_NOT_RECRUITING
Nanchang
Jiangsu Province Cancer Hospital
ACTIVE_NOT_RECRUITING
Nanjing
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Ningbo First Hospital
COMPLETED
Ningbo
The Second Affiliated Hospital of Fujian Medical University
RECRUITING
Quanzhou
Affiliated Zhongshan Hospital of Fudan University
ACTIVE_NOT_RECRUITING
Shanghai
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Huadong Hospital Affiliated to Fudan University
COMPLETED
Shanghai
Huashan Hospital Affiliated to Fudan University
COMPLETED
Shanghai
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Changhai Hospital
COMPLETED
Shanghai
Liaoning Cancer Hospital and Institute
ACTIVE_NOT_RECRUITING
Shenyang
The Second Affiliated Hospital of Tianjin Medical University
RECRUITING
Tianjin
Affiliated Cancer Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
The First Provincial Wenzhou Hospital of Zhejiang
RECRUITING
Wenzhou
Hubei Cancer Hospital
ACTIVE_NOT_RECRUITING
Wuhan
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
ACTIVE_NOT_RECRUITING
Wuhan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The Second Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Taiwan
Keelung Chang Gung Memorial Hospital and Loves Lake Branch
COMPLETED
Anle Dist
Taipei Veterans General Hospital
COMPLETED
Beitou Dist
Linkou Chang Gung Memorial Hospital
COMPLETED
Guishan Dist
National Cheng Kung University Hospital
COMPLETED
North Dist
National Taiwan University Hospital
COMPLETED
Zhongzheng Dist
Contact Information
Primary
BeiGene
clinicaltrials@beigene.com
+1-877-828-5568
Time Frame
Start Date: 2019-05-29
Estimated Completion Date: 2027-10-21
Participants
Target number of participants: 420
Treatments
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
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
Authors
Related Therapeutic Areas
Sponsors
Leads: BeiGene