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Brief Title: Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)
Official Title: A Phase III Randomized Double-blind Study of Pembrolizumab Plus Best Supportive Care vs. Placebo Plus Best Supportive Care as Second-Line Therapy in Asian Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-394)
Study ID: NCT03062358
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Jiangsu Cancer Hospital ( Site 0003), Nanjing, Jiangsu, China
The 81st Hospital of PLA ( Site 0016), Nanjing, Jiangsu, China
Nantong Tumor Hospital ( Site 0028), Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University ( Site 0025), Suzhou, Jiangsu, China
Yangzhou No.1 People's Hospital ( Site 0023), Yangzhou, Jiangsu, China
The First Hospital Of Jilin University ( Site 0001), Chang Chun, Jilin, China
Jilin Province Cancer Hospital, Department of Chemotherapy ( Site 0002), Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University ( Site 0022), Dalian, Liaoning, China
Fudan University Shanghai Cancer Center ( Site 0024), Shanghai, Shanghai, China
The first affiliated Hospital of Xi an Jiaotong University ( Site 0014), XI An, Shanxi, China
West China Hospital of Sichuan University ( Site 0030), Chengdu, Sichuan, China
The First affiliated Hospital Zhejing University ( Site 0034), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0011), Hangzhou, Zhejiang, China
Beijing Cancer Hospital ( Site 0010), Beijing, , China
Bengbu Medical College First Affiliated Hospital ( Site 0020), Bengbu, , China
The Second Affiliated Hospital of Anhui Medical University ( Site 0008), Hefei, , China
Zhongshan Hospital Fudan University ( Site 0012), Shanghai, , China
Renji Hosp,Shanghai Jiao Tong University School of Medicine ( Site 0017), Shanghai, , China
Hong Kong Sanatorium Hospital ( Site 0053), Hong Kong, , Hong Kong
Pamela Youde Nethersole Eastern Hospital ( Site 0052), Hong Kong, , Hong Kong
Princess Margaret Hospital. ( Site 0051), Hong Kong, , Hong Kong
Asan Medical Center ( Site 0072), Seoul., , Korea, Republic of
Seoul National University Hospital ( Site 0074), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0073), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0071), Seoul, , Korea, Republic of
Beacon Hospital Sdn Bhd ( Site 0092), Petaling Jaya, Selangor, Malaysia
University Malaya Medical Centre ( Site 0091), Kuala Lumpur, Wilayah Persekutuan, Malaysia
Hospital Universiti Kebangsaan Malaysia ( Site 0093), Cheras, , Malaysia
Chia-Yi Chang Gung Memorial Hospital ( Site 0133), Chiayi, , Taiwan
China Medical University Hospital ( Site 0131), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0132), Tainan, , Taiwan
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR