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A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Sponsor: Bristol-Myers Squibb
Summary
The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Official title: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
732
Start Date
2019-09-30
Completion Date
2026-07-09
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
Participants will receive nivolumab as intravenous (IV) infusion.
Ipilimumab
Participants will receive ipilimumab as IV infusion.
Sorafenib
Participants will receive sorafenib as oral tablets.
lenvatinib
Participants will receive lenvatinib as oral capsules.
Locations (210)
Local Institution - 0292
Tucson, Arizona, United States
Local Institution - 0288
Coronado, California, United States
Local Institution - 0157
Duarte, California, United States
Local Institution - 0077
Washington D.C., District of Columbia, United States
Local Institution - 0027
Louisville, Kentucky, United States
Local Institution - 0190
Baltimore, Maryland, United States
Local Institution
Ann Arbor, Michigan, United States
Local Institution - 0018
Detroit, Michigan, United States
Local Institution - 0295
Newark, New Jersey, United States
Local Institution - 0043
Toledo, Ohio, United States
Local Institution - 0284
Pittsburgh, Pennsylvania, United States
Local Institution - 0304
Dallas, Texas, United States
Local Institution - 0202
Houston, Texas, United States
Local Institution - 0046
Lubbock, Texas, United States
Local Institution - 0172
Salt Lake City, Utah, United States
Local Institution - 0037
Caba, Buenos Aires, Argentina
Local Institution - 0194
Pilar, Buenos Aires, Argentina
Local Institution - 0282
Rosario, Santa Fe Province, Argentina
Local Institution - 0136
Buenos Aires, Argentina
Local Institution - 0058
San Miguel de Tucumán, Argentina
Local Institution - 0003
Kogarah, New South Wales, Australia
Local Institution - 0038
Liverpool, New South Wales, Australia
Local Institution - 0002
Westmead, New South Wales, Australia
Local Institution - 0004
Birtinya, Queensland, Australia
Local Institution - 0013
Herston, Queensland, Australia
Local Institution - 0009
Adelaide, South Australia, Australia
Local Institution - 0019
Clayton, Victoria, Australia
Local Institution - 0026
Fitzroy, Victoria, Australia
Local Institution - 0001
Melbourne, Victoria, Australia
Local Institution - 0020
St Albans, Victoria, Australia
Local Institution - 0114
Sankt Pölten, Lower Austria, Austria
Local Institution - 0057
Wiener Neustadt, Lower Austria, Austria
Local Institution - 0188
Graz, Austria
Local Institution - 0065
Klagenfurt, Austria
Local Institution - 0186
Vienna, Austria
Local Institution - 0034
Brussels, Belgium
Local Institution - 0008
Federal District, Belgium
Local Institution - 0124
Ghent, Belgium
Local Institution - 0298
Ghent, Belgium
Local Institution - 0099
Haine-Saint-Paul, Belgium
Local Institution - 0064
Leuven, Belgium
Local Institution - 0104
Liège, Belgium
Local Institution - 0278
Vitória, Espírito Santo, Brazil
Local Institution
Salvador, Estado de Bahia, Brazil
Local Institution - 0061
Salvador, Estado de Bahia, Brazil
Local Institution - 0181
Brasília, Federal District, Brazil
Local Institution - 0279
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0060
Pelotas, Rio Grande do Sul, Brazil
Local Institution - 0054
Jaú, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0016
Paranã, Brazil
Local Institution - 0015
Rio de Janeiro, Brazil
Local Institution - 0023
São Paulo, Brazil
Local Institution - 0022
São Paulo, Brazil
Local Institution - 0050
São Paulo, Brazil
Local Institution - 0192
Edmonton, Alberta, Canada
Local Institution - 0094
La Serena, Coquimbo Region, Chile
Local Institution - 0296
Temuco, Región de la Araucanía, Chile
Local Institution - 0012
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0216
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0283
Santiago, RM, Chile
Local Institution - 0095
Santiago, Santiago Metropolitan, Chile
Local Institution - 0024
Santiago, Santiago Metropolitan, Chile
Local Institution - 0156
Santiago, Santiago Metropolitan, Chile
Local Institution - 0120
Hefei, Anhui, China
Local Institution - 0146
Hefei, Anhui, China
Local Institution - 0175
Beijing, Beijing Municipality, China
Local Institution - 0152
Beijing, Beijing Municipality, China
Local Institution - 0151
Fuzhou, Fujian, China
Local Institution - 0121
Fuzhou, Fujian, China
Local Institution - 0125
Guangzhou, Guangdong, China
Local Institution - 0150
Guangzhou, Guangdong, China
Local Institution - 0135
Harbin, Heilongjiang, China
Local Institution - 0109
Changsha, Hunan, China
Local Institution - 0059
Changsha, Hunan, China
Local Institution - 0130
Nanjing, Jiangsu, China
Local Institution - 0145
Nanchang, Jiangxi, China
Local Institution - 0149
Nanchang, Jiangxi, China
Local Institution - 0162
Changchun, Jilin, China
Local Institution - 0166
Changchun, Jilin, China
Local Institution - 0131
Dalian, Liaoning, China
Local Institution - 0123
Shenyang, Liaoning, China
Local Institution - 0132
Shenyang, Liaoning, China
Local Institution - 0133
Xi'an, Shaanxi, China
Local Institution - 0147
Xi'an, Shan3xi, China
Local Institution - 0307
Xi'an, Shan3xi, China
Local Institution - 0153
Qingdao, Shandong, China
Local Institution - 0134
Shanghai, Shanghai Municipality, China
Local Institution - 0179
Chongqing, Sichuan, China
Local Institution - 0108
Hangzhou, Zhejiang, China
Local Institution - 0107
Hangzhou, Zhejiang, China
Local Institution - 0274
Prague, Prague, Czechia
Local Institution
Brno, Czechia
Local Institution - 0068
Amiens, France
Local Institution - 0116
Caen, France
Local Institution - 0069
Clichy, France
Local Institution - 0138
Dijon, France
Local Institution - 0081
Grenoble, France
Local Institution - 0070
Lyon, France
Local Institution
Marseille, France
Local Institution - 0082
Montpellier, France
Local Institution - 0067
Nice, France
Local Institution - 0025
Pessac, France
Local Institution - 0137
Poitiers, France
Local Institution - 0042
Toulouse, France
Local Institution - 0071
Vandœuvre-lès-Nancy, France
Local Institution - 0051
Villejuif, France
Local Institution - 0005
Frankfurt am Main, Hesse, Germany
Local Institution - 0231
Bonn, Germany
Local Institution - 0028
Cologne, Germany
Local Institution - 0052
Essen, Germany
Local Institution - 0185
Freiburg im Breisgau, Germany
Local Institution - 0006
Hamburg, Germany
Local Institution - 0102
Hanover, Germany
Local Institution - 0118
Leipzig, Germany
Local Institution - 0031
Mainz, Germany
Local Institution - 0056
Mannheim, Germany
Local Institution
München, Germany
Local Institution - 0053
North Rhine-Westphalia, Germany
Local Institution - 0036
Hong Kong, Hong Kong
Local Institution - 0032
Hong Kong, Hong Kong
Local Institution - 0110
Meldola, Forli-Cesena, Italy
Local Institution - 0101
Rozzano, Milano, Italy
Local Institution - 0084
Candiolo, Italy
Local Institution - 0039
Milan, Italy
Local Institution - 0100
Novara, Italy
Local Institution - 0219
Padova, Italy
Local Institution - 0033
Parma, Italy
Local Institution - 0112
Roma, Italy
Local Institution - 0079
Rome, Italy
Local Institution - 0111
Siena, Italy
Local Institution - 0044
Vicenza, Italy
Local Institution - 0193
Kashiwa-shi, Chiba, Japan
Local Institution - 0203
Matsuyama, Ehime, Japan
Local Institution - 0176
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0200
Yokohama, Kanagawa, Japan
Local Institution - 0262
Yokohama, Kanagawa, Japan
Local Institution - 0189
Kyoto, Kyoto, Japan
Local Institution - 0261
Kashihara, Nara, Japan
Local Institution - 0263
Abeno-ku, Osaka, Japan
Local Institution - 0127
Sayama, Osaka, Japan
Local Institution - 0281
Saga, Saga-ken, Japan
Local Institution - 0258
Iruma-gun, Saitama, Japan
Local Institution - 0259
Izunokuni-shi, Shizuoka, Japan
Local Institution - 0128
Minato, Tokyo, Japan
Local Institution - 0122
Minato-ku, Tokyo, Japan
Local Institution - 0201
Mitaka, Tokyo, Japan
Local Institution - 0199
Musashino-shi, Tokyo, Japan
Local Institution - 0204
Chiba, Japan
Local Institution - 0178
Fukuoka, Japan
Local Institution - 0177
Hiroshima, Japan
Local Institution - 0155
Sapporo, Japan
Local Institution - 0286
Christchurch, Canterbury, New Zealand
Local Institution - 0047
Auckland, New Zealand
Local Institution - 0148
Gdansk, Poland
Local Institution - 0049
Otwock, Poland
Local Institution - 0092
Warsaw, Poland
Local Institution - 0289
Rio Piedras, Puerto Rico
Local Institution - 0035
San Juan, Puerto Rico
Local Institution - 0103
Craiova, Dolj, Romania
Local Institution - 0164
Bucharest, Romania
Local Institution - 0165
Cluj-Napoca, Romania
Local Institution
Craiova, Romania
Local Institution - 0163
Timișoara, Romania
Local Institution - 0029
Arkhangelsk, Russia
Local Institution - 0066
Barnaul, Russia
Local Institution - 0074
Chelyabinsk, Russia
Local Institution - 0007
Moscow, Russia
Local Institution - 0072
Pyatigorsk, Russia
Local Institution - 0075
Saint Petersburg, Russia
Local Institution - 0091
Saint Petersburg, Russia
Local Institution - 0073
Sochi, Russia
Local Institution - 0048
Singapore, Singapore
Local Institution - 0017
Singapore, Singapore
Local Institution - 0174
Singapore, Singapore
Local Institution - 0143
Seongnam-si, Gyeonggi-do, South Korea
Local Institution - 0167
Guro-gu, Seoul, South Korea
Local Institution - 0062
Jongno-gu, Seoul, South Korea
Local Institution - 0142
Busan, South Korea
Local Institution - 0097
Gyeonggi-do, South Korea
Local Institution - 0098
Gyeongsangnam-do, South Korea
Local Institution - 0141
Seoul, South Korea
Local Institution - 0140
Seoul, South Korea
Local Institution - 0139
Seoul, South Korea
Local Institution - 0297
Barcelona, Spain
Local Institution - 0055
Barcelona, Spain
Local Institution - 0089
Barcelona, Spain
Local Institution - 0090
Córdoba, Spain
Local Institution - 0087
El Palmar, Spain
Local Institution - 0041
Madrid, Spain
Local Institution - 0093
Madrid, Spain
Local Institution - 0290
Madrid, Spain
Local Institution - 0045
Majadahonda, Spain
Local Institution - 0085
Pamplona, Spain
Local Institution - 0088
Santander, Spain
Local Institution - 0040
Zaragoza, Spain
Local Institution - 0063
Bern, Switzerland
Local Institution - 0272
Kaohsiung City, Taiwan
Local Institution - 0096
Kaohsiung City, Taiwan
Local Institution - 0105
Taichung, Taiwan
Local Institution - 0271
Taichung, Taiwan
Local Institution - 0168
Tainan, Taiwan
Local Institution - 0270
Tainan, Taiwan
Local Institution - 0144
Taipei, Taiwan
Local Institution - 0078
Taipei, Taiwan
Local Institution - 0173
Taoyuan District, Taiwan
Local Institution - 0171
London, Greater London, United Kingdom
Local Institution - 0154
Guildford, Surrey, United Kingdom
Local Institution - 0160
Edinburgh, United Kingdom
Local Institution - 0129
London, United Kingdom