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Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
Sponsor: BeiGene
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2019-05-29
Completion Date
2027-10-21
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
Tislelizumab
200 mg administered Intravenously (IV) as specified in the treatment arm
Placebo
Tislelizumab placebo to match
Cisplatin
70 mg/m2 administered IV as specified in the treatment arm
Gemcitabine Hydrochloride
1000 mg/m2 administered IV as specified in the treatment arm
Carboplatin
Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm
Locations (46)
Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fifth Medical Center of Pla General Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chinese Pla General Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Cancer Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
The First Provincial Wenzhou Hospital of Zhejiang
Wenzhou, Zhejiang, China
Keelung Chang Gung Memorial Hospital and Loves Lake Branch
Anle Dist, Taiwan
Taipei Veterans General Hospital
Beitou Dist, Taiwan
Linkou Chang Gung Memorial Hospital
Guishan Dist, Taiwan
National Cheng Kung University Hospital
North Dist, Taiwan
National Taiwan University Hospital
Zhongzheng Dist, Taiwan