The purpose of this study is to determine the efficacy and safety of pembrolizumab or placebo given with best supportive care (BSC) in Asian participants with previously systemically treated advanced hepatocellular carcinoma (HCC). The primary hypothesis of this study is that overall survival is prolonged in participants who receive pembrolizumab compared to those who receive placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
453
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Normal saline solution administered as an IV infusion Q3W
BSC will include pain management and management of other potential complications including ascites per local standards of care.
Overall Survival (OS)
OS is the time from randomization to death due to any cause, based on the Kaplan-Meier method for censored data.
Time frame: Up to approximately 4 years
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS is the time from randomization to first documented disease progression or death due to any cause per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) based on the Kaplan-Meier method for censored data.
Time frame: Up to approximately 4 years
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR is the percentage of participants who achieve complete response (CR) or partial response (PR) with confirmation per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.
Time frame: Up to approximately 4 years
Duration Of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
DOR is the time from first documented evidence of CR or PR per RECIST 1.1 by BICR until disease progression per RECIST 1.1 by BICR or death, based on Kaplan-Meier method for censored data. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.
Time frame: Up to approximately 4 years
Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
DCR is the percentage of participants who achieve CR, PR, or stable disease (SD) for ≥5 weeks prior to evidence of disease progression per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Anhui Provincial Hospital ( Site 0032)
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University ( Site 0005)
Hefei, Anhui, China
Fuzhou General Hospital of Nanjing Military Command ( Site 0019)
Fuzhou, Fujian, China
The First People s Hospital of Foshan ( Site 0033)
Foshan, Guangdong, China
Guangdong General Hospital ( Site 0015)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 0007)
Harbin, Heilongjiang, China
Wuhan Tongji Hospital ( Site 0021)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 0035)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0027)
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University ( Site 0026)
Changsha, Hunan, China
...and 31 more locations
Time frame: Up to approximately 4 years
Time To Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
TTP is the time from randomization to first documented disease progression per RECIST 1.1 by BICR, based on Kaplan-Meier method for censored data.
Time frame: Up to approximately 4 years
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.
Time frame: Up to approximately 30 months.
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.
Time frame: Up to approximately 27 months.