Spots Global Cancer Trial Database for Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension
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Trial Identification
Brief Title: Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension
Official Title: A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)
Study ID: NCT04859582
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult Chinese participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).
Detailed Description: The China extension study will include participants previously enrolled in China in the global study for MK-3475-859 (NCT03675737) plus those enrolled during the China extension enrollment period. A total of approximately 231 Chinese participants will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421), Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 2425), Beijing, Beijing, China
Fujian Medical University Union Hospital ( Site 2410), Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital ( Site 2414), Fuzhou, Fujian, China
900 Hospital of the Joint ( Site 2418), Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 2430), Xiamen, Fujian, China
Zhongshan Hospital Xiamen University ( Site 2447), Xiamen, Fujian, China
Guangdong General Hospital ( Site 2431), Guangzhou, Guangdong, China
Peking University Shenzhen Hospital ( Site 2442), Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 2401), Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 2415), Zhengzhou, Henan, China
Hubei Cancer Hospital ( Site 2434), Wuhan, Hubei, China
Xiangya Hospital Central-South University ( Site 2419), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2439), Changsha, Hunan, China
Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441), Changzhou, Jiangsu, China
The 81st Hospital of PLA ( Site 2413), Nanjing, Jiangsu, China
Jiangsu Cancer Hospital ( Site 2432), Nanjing, Jiangsu, China
Yancheng First People s Hospital ( Site 2426), Yancheng, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 2440), Nanchang, Jiangxi, China
The First Hospital of Jilin University ( Site 2416), Chang chun, Jilin, China
The Affiliated Hospital of Qingdao University ( Site 2405), Qingdao, Shandong, China
Shanghai East Hospital ( Site 2403), Shanghai, Shanghai, China
Zhongshan Hospital affiliated to Fudan University ( Site 2407), Shanghai, Shanghai, China
1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428), XiAn, Shanxi, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420), Urumqi, Xinjiang, China
Zhejiang Provincial People's Hospital ( Site 2446), Hangzhou, Zhejiang, China
Sir Run Run Show Hospital ( Site 2427), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2417), Hangzhou, Zhejiang, China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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