This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody BGB-A317 in participants with PD-L1+, locally advanced or metastatic Urothelial Bladder Cancer (UBC) who have progressed during or following a platinum-containing regimen
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
200mg intravenously (IV) every 3 weeks (Q3W)
Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by Independent Review Committee (IRC) using RECIST version 1.1
Time frame: From the date of first dose up to approximately 2 years and 2 months
Duration of Response (DOR) as Assessed by IRC
DOR - defined as the time from the first determination of a confirmed objective response by IRC according to RECIST version 1.1 until the first documentation of progression or death, whichever comes first
Time frame: From the date of first dose up to approximately 2 years and 2 months
Progression-Free Survival (PFS) as Assessed by IRC
PFS is defined as the time from the date of first dose of study drug to the date of first documentation of disease progression assessed by IRC using RECIST version 1.1 or death, whichever occurs first
Time frame: From the date of first dose up to approximately 2 years and 2 months
Disease Control Rate (DCR) as Assessed by IRC
DCR is defined as the percentage of participants who achieve CR, PR and stable disease (SD) assessed by IRC using RECIST version 1.1
Time frame: From the date of first dose up to approximately 2 years and 2 months
Overall Survival (OS)
OS - defined as the time from the date of first dose of study drug until the date of death from any cause
Time frame: From the date of first dose up to approximately 2 years and 2 months
ORR as Assessed by the Investigators
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigators per RECIST version 1.1 and immune related RECIST (irRECIST)
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Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
...and 17 more locations
Time frame: From the date of first dose up to approximately 2 years and 2 months
DOR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
DOR is defined as the time from the first determination of a confirmed objective response by the investigator according to RECIST version 1.1 and irRECIST until the first documentation of progression or death, whichever comes first
Time frame: From the date of first dose up to approximately 2 years and 2 months
PFS as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
PFS is defined as the time from the date of first dose of study drug to the date of first documentation of disease progression assessed by the investigator according to RECIST version 1.1 and irRECIST until the first documentation of progression or death, whichever comes first
Time frame: From the date of first dose up to approximately 2 years and 2 months
DCR as Assessed by Investigators Per RECIST Version 1.1 and irRECIST
DCR is defined as the percentage of participants who achieve CR, PR and stable disease (SD) assessed by investigators per RECIST version 1.1 and irRECIST
Time frame: From the date of first dose up to approximately 2 years and 2 months
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline pre-treatment) on or after the first dose of study drug up to 30 days following study drug .discontinuation. An SAE is any untoward medical occurrence that, at any dose that results in death or is life-threatening.
Time frame: From the date of first dose until End of Study (approximately 3 years and 9 months)