Spots Global Cancer Trial Database for Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study
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Trial Identification
Brief Title: Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study
Official Title: A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma
Study ID: NCT04924062
Conditions
Study Description
Brief Summary: In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
Detailed Description: The China extension study will include participants previously enrolled in China in the global study for MK-3475-966 (NCT04003636) plus those enrolled during the China extension enrollment period. A total of approximately 158 Chinese participants will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Hospital ( Site 0140), Hefei, Anhui, China
Beijing Cancer Hospital ( Site 0138), Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 0150), Beijing, Beijing, China
First Affiliated Hospital of The Third Military Medical University ( Site 0130), Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital ( Site 0154), Fuzhou, Fujian, China
900 Hospital of the Joint ( Site 0137), Fuzhou, Fujian, China
Guangdong Provincial People s Hospital ( Site 0161), Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 0133), Harbin, Heilongjiang, China
Hunan Provincial People Hospital ( Site 0142), Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0132), Changsha, Hunan, China
The Third Xiangya Hospital of Central South University ( Site 0157), Changsha, Hunan, China
The 81st Hospital of PLA ( Site 0128), Nanjing, Jiangsu, China
The First Hospital of Jilin University ( Site 0131), Chanchun, Jilin, China
Zhongshan Hospital Fudan University ( Site 0129), Shanghai, Shanghai, China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158), Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center ( Site 0160), Shanghai, Shanghai, China
Tangdu Hospital ( Site 0146), XI An, Shanxi, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145), XI An, Shanxi, China
West China Hospital of Sichuan University ( Site 0147), Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 0155), Tianjin, Tianjin, China
The First Affiliated Hospital Zhejiang University ( Site 0136), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0134), Hangzhou, Zhejiang, China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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