A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
NCT ID: NCT04340193
Last Updated: 2024-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
26 participants
INTERVENTIONAL
2020-09-14
2023-12-12
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 + Ipilimumab + TACE
TACE (Trans-arterial ChemoEmbolization)
nivolumab
Specified dose on specified days
ipilimumab
Specified dose on specified days
TACE
TACE (Trans-arterial ChemoEmbolization)
Nivolumab + TACE
nivolumab
Specified dose on specified days
TACE
TACE (Trans-arterial ChemoEmbolization)
TACE
TACE
TACE (Trans-arterial ChemoEmbolization)
Interventions
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nivolumab
Specified dose on specified days
ipilimumab
Specified dose on specified days
TACE
TACE (Trans-arterial ChemoEmbolization)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria
* Prior liver transplant or participants who are on the waiting list for liver transplantation
* Active, known, or suspected autoimmune disease
18 Years
ALL
No
Sponsors
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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 - 0189
Coronado, California, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution - 0005
Louisville, Kentucky, United States
Local Institution - 0059
Louisville, Kentucky, United States
Local Institution - 0109
Dallas, Texas, United States
Local Institution
Wollongong, New South Wales, Australia
Local Institution - 0037
Birtinya, Queensland, Australia
Local Institution - 0010
Adelaide, South Australia, Australia
Local Institution - 0001
Melbourne, Victoria, Australia
Local Institution - 0139
Murdoch, Western Australia, Australia
Local Institution - 0026
Graz, , Austria
Local Institution - 0013
Sankt Pölten, , Austria
Local Institution
Vienna, , Austria
Local Institution - 0078
West Springfield, , Austria
Local Institution - 0048
Wiener Neustadt, , Austria
Local Institution - 0020
Brussels, , Belgium
Local Institution
Federal District, , Belgium
Local Institution - 0053
Ghent, , Belgium
Local Institution - 0050
Plainfield, , Belgium
Local Institution - 0039
Québec, Quebec, Canada
Local Institution - 0184
Beijing, Beijing Municipality, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Tianjin, Hebei, China
Local Institution - 0196
Nanjing, Jiangsu, China
Local Institution - 0176
Nanchang, Jiangxi, China
Local Institution
Shenyang, Liaoning, China
Local Institution - 0209
Xi'an, Shan3xi, China
Local Institution - 0151
Shanghai, Shanghai Municipality, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution - 0055
Olomouc, , Czechia
Local Institution
Prague, , Czechia
Local Institution - 0014
Lille, Mount, France
Local Institution - 0132
Caen, , France
Local Institution - 0021
Clichy, , France
Local Institution - 0064
Dijon, , France
Local Institution - 0082
Englewood, , France
Local Institution - 0052
La Tronche, , France
Local Institution - 0061
Marseil, , France
Local Institution - 0087
Nantes, , France
Local Institution - 0012
Nice, , France
Local Institution - 0093
Paris, , France
Local Institution - 0046
Reims, , France
Local Institution - 0094
Villejuif, , France
Local Institution - 0035
Göttingen, , Germany
Local Institution
Hanover, , Germany
Local Institution
Heidelberg, , Germany
Local Institution - 0071
Leipzig, , Germany
Local Institution - 0004
Hong Kong, , Hong Kong
Local Institution - 0045
Hong Kong, , Hong Kong
Local Institution - 0015
Orbassano, TO, Italy
Local Institution
Messina, , Italy
Local Institution - 0025
Milan, , Italy
Local Institution
Monserrato, , Italy
Local Institution
Parma, , Italy
Local Institution
Roma, , Italy
Local Institution - 0076
Siena, , Italy
Local Institution - 0070
Vicenza, , Italy
Local Institution - 0108
Chiba, Chiba, Japan
Local Institution - 0122
Matsuyama, Ehime, Japan
Local Institution - 0148
Sapporo, Hokkaido, Japan
Local Institution - 0118
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0120
Yokohama, Kanagawa, Japan
Local Institution - 0113
Yokohama, Kanagawa, Japan
Local Institution - 0115
Kyoto, Kyoto, Japan
Local Institution - 0127
Abeno-ku, Osaka, Japan
Local Institution - 0125
Izunokuni-Shi, Shizuoka, Japan
Local Institution - 0116
Minato-ku, Tokyo, Japan
Local Institution - 0128
Minato-ku, Tokyo, Japan
Local Institution - 0121
Musashino-shi, Tokyo, Japan
Local Institution - 0119
Hiroshima, , Japan
Local Institution - 0117
Osaka, , Japan
Local Institution - 0123
Saitama, , Japan
Local Institution
Warsaw, , Poland
Local Institution - 0049
San Juan, , Puerto Rico
Local Institution - 0016
Barnaul, , Russia
Local Institution - 0077
Saint Petersburg, , Russia
Local Institution - 0009
Saint Petersburg, , Russia
Local Institution - 0027
Singapore, , Singapore
Local Institution - 0089
Singapore, , Singapore
Local Institution - 0011
Singapore, , Singapore
Local Institution - 0114
Busan, , South Korea
Local Institution - 0135
Daegu, , South Korea
Local Institution - 0047
Gyeongsangnam-do, , South Korea
Local Institution - 0097
Hwasun-Gun, , South Korea
Local Institution - 0161
Seoul, , South Korea
Local Institution - 0186
Seoul, , South Korea
Local Institution - 0160
Seoul, , South Korea
Local Institution - 0164
Seoul, , South Korea
Local Institution - 0023
Alicante, , Spain
Local Institution - 0092
Córdoba, , Spain
Local Institution - 0101
Madrid, , Spain
Local Institution - 0183
Madrid, , Spain
Local Institution - 0084
Madrid, , Spain
Local Institution - 0018
Madrid, , Spain
Local Institution - 0099
Pamplona, , Spain
Local Institution - 0131
Sabadell, , Spain
Local Institution - 0102
Santiago de Compostela, , Spain
Local Institution - 0136
Buzi, , Taiwan
Local Institution - 0141
Kaohsiung City, , Taiwan
Local Institution - 0030
Taichung, , Taiwan
Local Institution - 0057
Taichung, , Taiwan
Local Institution - 0029
Tainan City, , Taiwan
Local Institution - 0002
Taipei, , Taiwan
Local Institution - 0044
Tapei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA209-74W
Identifier Type: -
Identifier Source: org_study_id
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