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Clinical Trials in China / NCT03967977
Active, not recruiting Phase 3

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

NCT03967977 · tracked via the Priya Life Science China tracker
Sponsor
BeiGene
Phase
Phase 3
Started
2019-05-29
Last updated
2026-06-22

Condition(s) studied

Urothelial Carcinoma

Investigational drug(s) / intervention(s)

TislelizumabPlaceboCisplatinGemcitabine HydrochlorideCarboplatin

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui
Peking University Third Hospital Beijing Beijing Municipality
Peking University First Hospital Beijing Beijing Municipality
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality
Fifth Medical Center of Pla General Hospital Beijing Beijing Municipality
Beijing Cancer Hospital Beijing Beijing Municipality
Peking Union Medical College Hospital Beijing Beijing Municipality
Chinese Pla General Hospital Beijing Beijing Municipality
Chongqing Cancer Hospital Chongqing Chongqing Municipality
Southwest Hospital Chongqing Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
The Second Affiliated Hospital of Fujian Medical University Quanzhou Fujian
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) Guangzhou Guangdong
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Hubei Cancer Hospital Wuhan Hubei
Xiangya Hospital of Central South University Changsha Hunan
Jiangsu Province Cancer Hospital Nanjing Jiangsu
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu
The First Affiliated Hospital of Nanchang University Branch Donghu Nanchang Jiangxi
The First Hospital of Jilin University Changchun Jilin
Liaoning Cancer Hospital and Institute Shenyang Liaoning
The Second Affiliated Hospital of Xian Jiaotong University Xi'an Shaanxi
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Affiliated Zhongshan Hospital of Fudan University Shanghai Shanghai Municipality
Huadong Hospital Affiliated to Fudan University Shanghai Shanghai Municipality
Huashan Hospital Affiliated to Fudan University Shanghai Shanghai Municipality
Shanghai Changhai Hospital Shanghai Shanghai Municipality
West China Hospital, Sichuan University Chengdu Sichuan
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu Sichuan
The Second Affiliated Hospital of Tianjin Medical University Tianjin Tianjin Municipality
Affiliated Cancer Hospital of Xinjiang Medical University Ürümqi Xinjiang
Yunnan Cancer Hospital Kunming Yunnan
Zhejiang Provincial Peoples Hospital Hangzhou Zhejiang
Zhejiang Cancer Hospital Hangzhou Zhejiang
Ningbo First Hospital Ningbo Zhejiang

+ 6 more sites — see the full list on the official registry below.

More BeiGene trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03967977 on ClinicalTrials.gov ↗ ← All trials in China