Spots Global Cancer Trial Database for Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension
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Trial Identification
Brief Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension
Official Title: A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
Study ID: NCT04882241
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated Chinese adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. No formal hypothesis testing will be done.
Detailed Description: The China extension study will include participants previously enrolled in China in the global study for MK-3475-585 (NCT03221426) plus those enrolled during the China extension enrollment period. A total of approximately 120 Chinese participants will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Afflilated Hospital of Bengbu Medical College-Surgical Oncology (Site 0638), Bengbu, Anhui, China
Beijing Friendship Hospital ( Site 0637), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 0221), Beijing, Beijing, China
Fujian Medical University Union Hospital-1 Bingfanglou-Gastric Surgery Department (Site 0632), Fuzhou Fujian, Fujian, China
Fujian Provincial Cancer Hospital ( Site 0230), Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University (Site 0635), Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 0224), Guangzhou, Guangdong, China
Fourth Hospital of Hebei Medical University ( Site 0633), Shijiazhuang, Hebei, China
Henan Cancer Hospital (Site 0227), Zhengzhou, Henan, China
The Affiliated Hospital of Xuzhou Medical College-Oncology ( Site 0645), Xuzhou, Jiangsu, China
The First Hospital of Jilin University-Gastrointestinal Surgery ( Site 0234), Changchun, Jilin, China
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 0647), Xi'an, Shaanxi, China
Shandong Provincial Hospital-Gastrointestinal Surgery ( Site 0640), Jinan, Shandong, China
The Affiliated Hospital of Qingdao University ( Site 0636), Qingdao, Shandong, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0642), Shanghai, Shanghai, China
Sichuan Cancer hospital, Chengdu, Sichuan, China
Zhejiang Provincial People's Hospital-Oncology (Site 0656), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0231), Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital ( Site 0233), Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University (Site 0652), Wenzhou, Zhejiang, China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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