An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT02576509
Last Updated: 2025-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
743 participants
INTERVENTIONAL
2015-12-07
2024-02-07
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
NONE
Study Groups
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Nivolumab
Nivolumab specified dose on specified days
Nivolumab
Specified Dose on Specified Days
Sorafenib
Sorafenib specified dose on specified days
Sorafenib
Specified Dose on Specified Days
Interventions
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Nivolumab
Specified Dose on Specified Days
Sorafenib
Specified Dose on Specified Days
Eligibility Criteria
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Inclusion Criteria
* Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
* Child-Pugh Class A
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria
* Prior liver transplant
* Active, known, or suspected autoimmune disease
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0066
Birmingham, Alabama, United States
Local Institution - 0020
Los Angeles, California, United States
Local Institution - 0015
San Francisco, California, United States
Local Institution - 0084
San Francisco, California, United States
Local Institution - 0061
Chicago, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Local Institution - 0083
New York, New York, United States
Local Institution - 0093
New York, New York, United States
Local Institution - 0016
Charlotte, North Carolina, United States
Local Institution - 0095
Philadelphia, Pennsylvania, United States
Local Institution - 0019
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Local Institution - 0017
San Antonio, Texas, United States
Scott & White Memorial Hospital And Clinic
Temple, Texas, United States
Local Institution - 0026
Seattle, Washington, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution - 0050
Madison, Wisconsin, United States
Local Institution - 0005
Camperdown, New South Wales, Australia
Local Institution - 0007
Adelaide, South Australia, Australia
Local Institution - 0001
Clayton, Victoria, Australia
Local Institution - 0002
Heidelberg, Victoria, Australia
Local Institution - 0003
Prahran, Victoria, Australia
Local Institution - 0008
Nedlands, Western Australia, Australia
Local Institution - 0039
Graz, , Austria
Local Institution - 0038
Vienna, , Austria
Local Institution - 0075
Brussels, , Belgium
Local Institution - 0091
Leuven, , Belgium
Local Institution - 0077
Liège, , Belgium
Local Institution - 0043
Calgary, Alberta, Canada
Local Institution - 0044
Vancouver, British Columbia, Canada
Local Institution - 0042
Québec, Quebec, Canada
Local Institution - 0164
Hefei, Anhui, China
Local Institution - 0139
Beijing, Beijing Municipality, China
Local Institution - 0137
Beijing, Beijing Municipality, China
Local Institution - 0140
Beijing, Beijing Municipality, China
Local Institution - 0141
Beijing, Beijing Municipality, China
Local Institution - 0152
Fuzhou, Fujian, China
Local Institution - 0161
Guangzhou, Guangdong, China
Local Institution - 0157
Guangzhou, Guangdong, China
Local Institution - 0144
Guangzhou, Guangdong, China
Local Institution - 0158
Nanning, Guangxi, China
Local Institution - 0142
Harbin, Heilongjiang, China
Local Institution - 0148
Changsha, Hunan, China
Local Institution - 0162
Changsha, Hunan, China
Local Institution - 0169
Changzhou, Jiangsu, China
Local Institution - 0135
Nanjing, Jiangsu, China
Local Institution - 0136
Changchun, Jilin, China
Local Institution - 0163
Changchun, Jilin, China
Local Institution - 0166
Dalian, Liaoning, China
Local Institution - 0138
Xi'an, Shan3xi, China
Local Institution - 0145
Shanghai, Shanghai Municipality, China
Local Institution - 0151
Shanghai, Shanghai Municipality, China
Local Institution - 0159
Tianjin, Tianjin Municipality, China
Local Institution - 0173
Hangzhou, Zhejiang, China
Local Institution - 0146
Hangzhou, Zhejiang, China
Local Institution - 0029
Brno, , Czechia
Local Institution - 0027
Hradec Králové, , Czechia
Local Institution - 0028
Olomouc, , Czechia
Local Institution - 0071
La Tronche, , France
Local Institution - 0072
Lille, , France
Local Institution - 0069
Lyon, , France
Local Institution - 0073
Montpellier, , France
Local Institution - 0067
Paris, , France
Local Institution - 0068
Pessac, , France
Local Institution - 0070
Rennes, , France
Local Institution - 0074
Toulouse, , France
Local Institution - 0036
Berlin, , Germany
Local Institution - 0037
Essen, , Germany
Local Institution - 0167
Frankfurt, , Germany
Local Institution - 0034
Hamburg, , Germany
Local Institution - 0031
Leipzig, , Germany
Local Institution - 0035
Mainz, , Germany
Local Institution - 0033
Munich, , Germany
Local Institution - 0032
Regensburg, , Germany
Local Institution - 0030
Tübingen, , Germany
Local Institution - 0011
Hong Kong, , Hong Kong
Local Institution - 0012
Hong Kong, , Hong Kong
Local Institution - 0082
Haifa, , Israel
Local Institution - 0060
Jerusalem, , Israel
Local Institution - 0058
Petah Tikva, , Israel
Local Institution - 0059
Tel Aviv, , Israel
Local Institution - 0054
Benevento, , Italy
Local Institution - 0062
Bergamo, , Italy
Local Institution - 0055
Milan, , Italy
Local Institution - 0063
Orbassano, , Italy
Local Institution - 0064
Siena, , Italy
Local Institution - 0100
Chiba, Chiba, Japan
Local Institution - 0103
Matsuyama, Ehime, Japan
Local Institution - 0107
Kurume-shi, Fukuoka, Japan
Local Institution - 0127
Ogaki-shi, Gifu, Japan
Local Institution - 0102
Sapporo, Hokkaido, Japan
Local Institution - 0130
Sapporo, Hokkaido, Japan
Local Institution - 0105
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0110
Kawasaki-shi, Kanagawa, Japan
Local Institution - 0112
Yokohama, Kanagawa, Japan
Local Institution - 0104
Yokohama, Kanagawa, Japan
Local Institution - 0111
Kyoto, Kyoto, Japan
Local Institution - 0106
Osaka-Sayama-Shi, Osaka, Japan
Local Institution - 0113
Suita, Osaka, Japan
Local Institution - 0115
Saga, Saga-ken, Japan
Local Institution - 0131
Chiyoda-ku, Tokyo, Japan
Local Institution - 0114
Mitaka-shi, Tokyo, Japan
Local Institution - 0108
Musashino-shi, Tokyo, Japan
Local Institution - 0126
Shinjuku-ku, Tokyo, Japan
Local Institution - 0101
Hiroshima, , Japan
Local Institution - 0023
Gdansk, , Poland
Local Institution - 0056
Warsaw, , Poland
Local Institution - 0045
Wroclaw, , Poland
Local Institution - 0096
Moscow, , Russia
Local Institution - 0013
Singapore, , Singapore
Local Institution - 0014
Singapore, , Singapore
Local Institution - 0117
Seoul, Seocho-gu, South Korea
Local Institution - 0125
Daegu, , South Korea
Local Institution - 0116
Goyang-si, , South Korea
Local Institution - 0118
Jeollanam-do, , South Korea
Local Institution - 0123
Seoul, , South Korea
Local Institution - 0119
Seoul, , South Korea
Local Institution - 0122
Seoul, , South Korea
Local Institution - 0124
Seoul, , South Korea
Local Institution - 0065
Alicante, , Spain
Local Institution - 0085
Majadahonda - Madrid, , Spain
Local Institution - 0009
Pamplona, , Spain
Local Institution - 0010
Santiago Compostela, , Spain
Local Institution - 0088
Gothenburg, , Sweden
Local Institution - 0087
Stockholm, , Sweden
Local Institution - 0040
Basel, , Switzerland
Local Institution - 0041
Bern, , Switzerland
Local Institution - 0129
Kaohsiung County, , Taiwan
Local Institution - 0133
Taichung, , Taiwan
Local Institution - 0121
Tainan City, , Taiwan
Local Institution - 0132
Tainan City, , Taiwan
Local Institution - 0099
Taipei, , Taiwan
Local Institution - 0120
Taipei, , Taiwan
Local Institution - 0128
Taoyuan, , Taiwan
Local Institution - 0080
London, Greater London, United Kingdom
Local Institution - 0078
London, Greater London, United Kingdom
Local Institution - 0079
Glasgow, Lanarkshire, United Kingdom
Local Institution - 0081
Liverpool, , United Kingdom
Countries
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References
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Zhou X, Cao J, Topatana W, Xie T, Chen T, Hu J, Li S, Juengpanic S, Lu Z, Zhang B, Wang K, Feng X, Shen J, Chen M. Evaluation of PD-L1 as a biomarker for immunotherapy for hepatocellular carcinoma: systematic review and meta-analysis. Immunotherapy. 2023 Apr;15(5):353-365. doi: 10.2217/imt-2022-0168. Epub 2023 Feb 27.
Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.
Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1):e003133. doi: 10.1136/jitc-2021-003133.
Yau T, Park JW, Finn RS, Cheng AL, Mathurin P, Edeline J, Kudo M, Harding JJ, Merle P, Rosmorduc O, Wyrwicz L, Schott E, Choo SP, Kelley RK, Sieghart W, Assenat E, Zaucha R, Furuse J, Abou-Alfa GK, El-Khoueiry AB, Melero I, Begic D, Chen G, Neely J, Wisniewski T, Tschaika M, Sangro B. Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2022 Jan;23(1):77-90. doi: 10.1016/S1470-2045(21)00604-5. Epub 2021 Dec 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA209-459
Identifier Type: -
Identifier Source: org_study_id
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