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
NCT ID: NCT04924062
Last Updated: 2025-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
158 participants
INTERVENTIONAL
2020-07-10
2025-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A (Pembrolizumab+Gemcitabine+Cisplatin)
Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Pembrolizumab
Pembrolizumab by intravenous (IV) infusion
Gemcitabine
Gemcitabine by IV infusion
Cisplatin
Cisplatin by IV infusion
Arm B (Placebo+Gemcitabine+Cisplatin)
Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Gemcitabine
Gemcitabine by IV infusion
Cisplatin
Cisplatin by IV infusion
Placebo
Placebo to pembrolizumab
Interventions
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Pembrolizumab
Pembrolizumab by intravenous (IV) infusion
Gemcitabine
Gemcitabine by IV infusion
Cisplatin
Cisplatin by IV infusion
Placebo
Placebo to pembrolizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Countries
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References
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Yoo C, Ueno M, Klumpen HJ, Kelley RK, Vogel A, Furuse J, Ren Z, Yau T, Chan SL, Ozaka M, Oh SC, Gu S, Park JO, Valle JW, Edeline J, Kim JG, Kamble S, Norquist JM, Yu L, Malhotra U, Finn RS. Health-related quality of life in participants with advanced biliary tract cancer from the randomized phase III KEYNOTE-966 study. J Hepatol. 2025 Sep;83(3):692-700. doi: 10.1016/j.jhep.2025.03.019. Epub 2025 Mar 27.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-966
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-966
Identifier Type: OTHER
Identifier Source: secondary_id
195007
Identifier Type: REGISTRY
Identifier Source: secondary_id
3475-966 China Extension
Identifier Type: -
Identifier Source: org_study_id
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