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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Director

Affiliation: Merck Sharp & Dohme LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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