Clinical trial NCT03967977: Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Urothelial Carcinoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2019-05-30
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Overall survival (OS) in the Intent to Treat (ITT) set
timeFrame: From first randomization up to 3.5 years, approximately
Secondary outcomes:
measure: Overall response rate (ORR) per RECIST v1.1 in ITT
timeFrame: From first randomization up to 3.5 years, approximately
measure: Duration of response (DOR)
timeFrame: From first randomization up to 3.5 years, approximately
measure: Progression-free survival (PFS)
timeFrame: From first randomization up to 3.5 years, approximately
measure: Overall survival rate at 1 and 2 years for each treatment arm
timeFrame: From first randomization up to 3.5 years, approximately
measure: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30)
timeFrame: From first randomization up to 3.5 years, approximately
measure: Incidence and severity of treatment-emergent adverse events (AEs)
timeFrame: From first randomization up to 3.5years, approximately
measure: Change from baseline in European Quality of Life 5-Dimension, 5-Level version (EQ-5D-5L)
timeFrame: From first randomization up to 3.5 years, approximately
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Fifth Medical Center of Pla General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese Pla General Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Xian
country: China
facility: The Second Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Affiliated Zhongshan Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
state: Sichuan
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin Medical University
state: Tianjin
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial Peoples Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Provincial Wenzhou Hospital of Zhejiang
state: Zhejiang
city: Anle Dist
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital and Loves Lake Branch
city: Beitou Dist
country: Taiwan
facility: Taipei Veterans General Hospital
city: Guishan Dist
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: North Dist
country: Taiwan
facility: National Cheng Kung University Hospital
city: Zhongzheng Dist
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Fudan University
name: Dingwei Ye, MD
role: PRINCIPAL_INVESTIGATOR
References: