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

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

July 10, 2020

Primary Completion Date

December 15, 2022

Study Completion Date

March 25, 2025

Conditions
Biliary Tract Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab

Pembrolizumab by intravenous (IV) infusion

DRUG

Gemcitabine

Gemcitabine by IV infusion

DRUG

Cisplatin

Cisplatin by IV infusion

DRUG

Placebo

Placebo to pembrolizumab

Trial Locations (22)

100036

Beijing Cancer Hospital ( Site 0138), Beijing

100730

Peking Union Medical College Hospital ( Site 0150), Beijing

130021

The First Hospital of Jilin University ( Site 0131), Changchun

200032

Zhongshan Hospital Fudan University ( Site 0129), Shanghai

200127

Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158), Shanghai

201315

Fudan University Shanghai Cancer Center ( Site 0160), Shanghai

210031

The 81st Hospital of PLA ( Site 0128), Nanjing

230001

Anhui Provincial Hospital ( Site 0140), Hefei

300060

Tianjin Medical University Cancer Institute & Hospital ( Site 0155), Tianjin

310003

The First Affiliated Hospital Zhejiang University ( Site 0136), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 0134), Hangzhou

350014

Fujian Provincial Cancer Hospital ( Site 0154), Fuzhou

350025

900 Hospital of the Joint ( Site 0137), Fuzhou

400038

First Affiliated Hospital of The Third Military Medical University ( Site 0130), Chongqing

410005

Hunan Provincial People Hospital ( Site 0142), Changsha

410013

Hunan Cancer Hospital ( Site 0132), Changsha

The Third Xiangya Hospital of Central South University ( Site 0157), Changsha

510080

Guangdong Provincial People s Hospital ( Site 0161), Guangzhou

610000

Harbin Medical University Cancer Hospital ( Site 0133), Harbin

610041

West China Hospital of Sichuan University ( Site 0147), Chengdu

710038

Tangdu Hospital ( Site 0146), Xi’an

710048

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145), Xi’an

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04924062 - 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 | Biotech Hunter | Biotech Hunter