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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
Sponsor: Merck Sharp & Dohme LLC
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2020-07-10
Completion Date
2025-03-25
Last Updated
2026-04-15
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Pembrolizumab by intravenous (IV) infusion
Gemcitabine
Gemcitabine by IV infusion
Cisplatin
Cisplatin by IV infusion
Placebo
Placebo to pembrolizumab by IV infusion
Locations (22)
Anhui Provincial Hospital ( Site 0140)
Hefei, Anhui, China
Beijing Cancer Hospital ( Site 0138)
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 0150)
Beijing, Beijing Municipality, China
First Affiliated Hospital of The Third Military Medical University ( Site 0130)
Chongqing, Chongqing Municipality, 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)
Changchun, Jilin, China
Zhongshan Hospital Fudan University ( Site 0129)
Shanghai, Shanghai Municipality, China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 0160)
Shanghai, Shanghai Municipality, 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 Municipality, China
The First Affiliated Hospital Zhejiang University ( Site 0136)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0134)
Hangzhou, Zhejiang, China