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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

NCT04924062

CompletedPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Biliary Tract Carcinoma

Interventions: Pembrolizumab, Gemcitabine, Cisplatin, Placebo

Countries: China

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

* Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
* Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
* Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
* Has a life expectancy of greater than 3 months
* Has adequate organ function

Exclusion Criteria

* Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
* Has ampullary cancer
* Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
* Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
* Has had an allogenic tissue/solid organ transplant

Locations (22)

Hefei, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Fuzhou, Fujian, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Changsha, Hunan, China
Changsha, Hunan, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Changchun, Jilin, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Xi’an, Shanxi, China
Xi’an, Shanxi, China
Chengdu, Sichuan, China
Tianjin, Tianjin Municipality, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China