Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Urothelial Carcinoma
Спонсор: BeiGene
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
Tislelizumab
DRUG
Placebo
DRUG
Cisplatin
DRUG
Gemcitabine Hydrochloride
DRUG
Carboplatin
DRUG
Места на провеждане
46
Китай (41)
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
The First Hospital of Jilin University
Changchun , Jilin
Xiangya Hospital of Central South University
Changsha , Hunan
West China Hospital, Sichuan University
Chengdu , Sichuan
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu , Sichuan
Chongqing Cancer Hospital
Chongqing , Chongqing Municipality
Southwest Hospital
Chongqing , Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University
Fuzhou , Fujian
Zhujiang Hospital of Southern Medical University
Guangzhou , Guangdong
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou , Guangdong
Zhejiang Provincial Peoples Hospital
Hangzhou , Zhejiang
Zhejiang Cancer Hospital
Hangzhou , Zhejiang
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
Anhui Provincial Hospital
Hefei , Anhui
Yunnan Cancer Hospital
Kunming , Yunnan
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang , Jiangxi
Jiangsu Province Cancer Hospital
Nanjing , Jiangsu
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing , Jiangsu
Ningbo First Hospital
Ningbo , Zhejiang
The Second Affiliated Hospital of Fujian Medical University
Quanzhou , Fujian
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
Liaoning Cancer Hospital and Institute
Shenyang , Liaoning
The Second Affiliated Hospital of Tianjin Medical University
Tianjin , Tianjin Municipality
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi , Xinjiang
The First Provincial Wenzhou Hospital of Zhejiang
Wenzhou , Zhejiang
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
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an , Shaanxi
The First Affiliated Hospital of Xiamen University
Xiamen , Fujian
Taiwan (5)
Keelung Chang Gung Memorial Hospital and Loves Lake Branch
БГ
EN