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Brief Title: Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study
Official Title: A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects With Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus That Have Progressed After First-Line Standard Therapy (KEYNOTE-181)
Study ID: NCT03933449
Brief Summary: In the China extension study, Chinese participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of chemotherapy with paclitaxel, docetaxel, or irinotecan. The primary extension study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with chemotherapy.
Detailed Description: The China extension study will include participants previously enrolled in China in the global study for MK-3475-181 (NCT02564263) plus those enrolled during the China extension enrollment period. Per protocol, response/progression or adverse events during the second pembrolizumab course will not be counted towards efficacy outcome measures or safety outcome measures.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anhui Provincial Hospital ( Site 0708), Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University ( Site 0707), Hefei, Anhui, China
Harbin Medical University Cancer Hospital ( Site 0714), Harbin, Heilongjiang, China
Wuhan Tongji Hospital ( Site 0724), Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0722), Changsha, Hunan, China
Jiangsu Cancer Hospital (Site 0704), Nanjing, Jiangsu, China
PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0706), Nanjing, Jiangsu, China
The First Hospital Of Jilin University ( Site 0719), Chang chun, Jilin, China
Jilin Cancer Hospital ( Site 0718), Changchun, Jilin, China
Zhejiang Cancer Hospital ( Site 0726), Hangzhou, Zhejiang, China
Beijing Cancer Hospital ( Site 0700), Beijing, , China
Chinese PLA General Hospital (Site 0703), Beijing, , China
Peking Union Medical College Hospital ( Site 0712), Beijing, , China
Fujian Medical University Union Hospital ( Site 0721), Fuzhou, , China
Fujian Province Cancer Hospital ( ( Site 0717), Fuzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0705), Hangzhou, , China
Sir Sun Sun Shaw Hosp, Zhejiang Univ,Oncology dept. ( Site 0720), Hangzhou, , China
The Affiliated Hospital of Qingdao University ( Site 0709), Qingdao, , China
Ruijin Hospital, Shanghai Jiaotong University ( Site 0701), Shanghai, , China
Shanghai Chest Hospital ( Site 0727), Shanghai, , China
Fudan University Shanghai Cancer Center ( Site 0723), Shanghai, , China
Zhongshan Hospital affiliated to Fudan University ( Site 0715), Shanghai, , China
Henan Cancer Hospital ( Site 0725), Zhengzhou, , China
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR