A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT04039607
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 732
- Participants must have a diagnosis of HCC based on histological confirmation
- Participants must have an advanced HCC
- Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
- Child-Pugh score 5 or 6
- Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant
- Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
- Active brain metastases or leptomeningeal metastases
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sorafenib/lenvatinib lenvatinib - Nivolumab + Ipilimumab Nivolumab - Sorafenib/lenvatinib Sorafenib - Nivolumab + Ipilimumab Ipilimumab -
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 4 years
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to 4 years Duration of Response (DOR) Up to 4 years Time to Symptom Deterioration (TTSD) Up to 4 years
Trial Locations
- Locations (205)
Local Institution - 0295
🇺🇸Newark, New Jersey, United States
Local Institution - 0061
🇧🇷Salvador, Bahia, Brazil
Local Institution - 0038
🇦🇺Liverpool, New South Wales, Australia
Local Institution - 0284
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0279
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Local Institution - 0202
🇺🇸Houston, Texas, United States
Local Institution - 0188
🇦🇹Graz, Austria
Local Institution - 0095
🇨🇱Santiago de Chile, Metropolitana, Chile
Local Institution - 0156
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0282
🇦🇷Rosario, Santa Fe, Argentina
Local Institution - 0296
🇨🇱Temuco, Araucania, Chile
Local Institution - 0065
🇦🇹Klagenfurt, Austria
Local Institution - 0114
🇦🇹St. Polten, Niederosterreich, Austria
Local Institution - 0057
🇦🇹Wiener Neustadt, Niederosterreich, Austria
Local Institution - 0201
🇯🇵Mitaka, Tokyo, Japan
Local Institution - 0024
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0283
🇨🇱Santiago, RM, Chile
Local Institution - 0199
🇯🇵Musashino-shi, Tokyo, Japan
Local Institution - 0165
🇷🇴Cluj Napoca, Romania
Local Institution - 0173
🇨🇳Taoyuan, Taiwan
Local Institution - 0128
🇯🇵Minato, Tokyo, Japan
Local Institution - 0096
🇨🇳Kaohsiung, Taiwan
Local Institution - 0164
🇷🇴Bucharest, Romania
Local Institution - 0063
🇨🇭Bern, Switzerland
Local Institution - 0271
🇨🇳Taichung, Taiwan
Local Institution - 0168
🇨🇳Tainan, Taiwan
Local Institution - 0166
🇨🇳Changchun, Jilin, China
Local Institution - 0147
🇨🇳Xian, Shan3xi, China
Local Institution - 0018
🇺🇸Detroit, Michigan, United States
Local Institution
🇷🇴Craiova, Romania
Local Institution - 0043
🇺🇸Toledo, Ohio, United States
Local Institution - 0172
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0037
🇦🇷Caba, Buenos Aires, Argentina
Local Institution - 0136
🇦🇷Buenos Aires, Argentina
Local Institution - 0046
🇺🇸Lubbock, Texas, United States
Local Institution - 0003
🇦🇺Kogarah, New South Wales, Australia
Local Institution - 0058
🇦🇷Tucuman, Argentina
Local Institution - 0004
🇦🇺Birtinya, Queensland, Australia
Local Institution - 0013
🇦🇺Herston, Queensland, Australia
Local Institution - 0026
🇦🇺Fitzroy, Victoria, Australia
Local Institution - 0009
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0020
🇦🇺St Albans, Victoria, Australia
Local Institution - 0008
🇧🇪Federal District, Belgium
Local Institution - 0001
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0034
🇧🇪Brussels, Belgium
Local Institution - 0186
🇦🇹Viena, Austria
Local Institution - 0124
🇧🇪Gent, Belgium
Local Institution - 0298
🇧🇪Gent, Belgium
Local Institution - 0278
🇧🇷Vitoria, Espirito Santo, Brazil
Local Institution - 0064
🇧🇪Leuven, Belgium
Local Institution - 0104
🇧🇪Liege, Belgium
Local Institution - 0181
🇧🇷Brasilia, DF, Brazil
Local Institution - 0060
🇧🇷Pelotas, RIO Grande DO SUL, Brazil
Local Institution - 0054
🇧🇷Jau, SAO Paulo, Brazil
Local Institution - 0280
🇧🇷Sao Jose do Rio Preto, Sao Paulo, Brazil
Local Institution - 0016
🇧🇷Parana, Brazil
Local Institution - 0015
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0094
🇨🇱La Serena, Coquimbo, Chile
Local Institution - 0023
🇧🇷Sao Paulo, Brazil
Local Institution - 0022
🇧🇷Sao Paulo, Brazil
Local Institution - 0050
🇧🇷Sao Paulo, Brazil
Local Institution - 0152
🇨🇳Beijing, Beijing, China
Local Institution - 0146
🇨🇳Hefei, Anhui, China
Local Institution - 0120
🇨🇳Hefei Shi, Anhui, China
Local Institution - 0012
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0216
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0121
🇨🇳Fuzhou City, Fujian, China
Local Institution - 0175
🇨🇳Beijing, Beijing, China
Local Institution - 0125
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0151
🇨🇳Fuzhou, Fujian, China
Local Institution - 0135
🇨🇳Harbin, Heilongjiang, China
Local Institution - 0150
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0130
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0109
🇨🇳Changsha, Hunan, China
Local Institution - 0059
🇨🇳Changsha, Hunan, China
Local Institution - 0162
🇨🇳Changchun, Jilin, China
Local Institution - 0123
🇨🇳Shenyang, Liaoning, China
Local Institution - 0149
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0133
🇨🇳Xian, Shan3xi, China
Local Institution - 0132
🇨🇳Shenyang, Liaoning, China
Local Institution - 0131
🇨🇳Dalian, Liaoning, China
Local Institution - 0134
🇨🇳Shanghai, Shanghai, China
Local Institution - 0107
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0153
🇨🇳Qingdao, Shandong, China
Local Institution - 0179
🇨🇳Chongqing, Sichuan, China
Local Institution - 0068
🇫🇷Amiens, France
Local Institution - 0274
🇨🇿Praha, Prague, Czechia
Local Institution - 0116
🇫🇷Caen, France
Local Institution - 0025
🇫🇷Pessac, France
Local Institution - 0081
🇫🇷Grenoble Cedex 9, France
Local Institution - 0067
🇫🇷Nice, France
Local Institution - 0138
🇫🇷Dijon, France
Local Institution - 0070
🇫🇷Lyon, France
Local Institution - 0042
🇫🇷Toulouse Cedex 9, France
Local Institution - 0137
🇫🇷Poitiers, France
Local Institution - 0071
🇫🇷Vandoeuvre les Nancy, France
Local Institution - 0051
🇫🇷Villejuif, France
Local Institution - 0006
🇩🇪Hamburg, Germany
Local Institution - 0005
🇩🇪Frankfurt, Hessen, Germany
Local Institution - 0185
🇩🇪Freiburg, Germany
Local Institution - 0231
🇩🇪Bonn, Germany
Local Institution - 0102
🇩🇪Hannover, Germany
Local Institution - 0052
🇩🇪Essen, Germany
Local Institution - 0118
🇩🇪Leipzig, Germany
Local Institution - 0028
🇩🇪Koeln, Germany
Local Institution - 0031
🇩🇪Mainz, Germany
Local Institution - 0056
🇩🇪Mannheim, Germany
Local Institution - 0053
🇩🇪North Rhine-Westphalia, Germany
Local Institution - 0084
🇮🇹Candiolo, Italy
Local Institution - 0039
🇮🇹Milano, Italy
Local Institution - 0101
🇮🇹Rozzano, Milano, Italy
Local Institution - 0110
🇮🇹Meldola, Forli-Cesena, Italy
Local Institution - 0100
🇮🇹Novara, Italy
Local Institution - 0219
🇮🇹Padova, Italy
Local Institution - 0033
🇮🇹Parma, Italy
Local Institution - 0044
🇮🇹Vicenza, Italy
Local Institution - 0111
🇮🇹Siena, Italy
Local Institution - 0079
🇮🇹Rome, Italy
Local Institution - 0112
🇮🇹Roma, Italy
Local Institution - 0193
🇯🇵Kashiwa-shi, Chiba, Japan
Local Institution - 0203
🇯🇵Matsuyama, Ehime, Japan
Local Institution - 0176
🇯🇵Kanazawa, Ishikawa, Japan
Local Institution - 0200
🇯🇵Yokohama-Shi, Kanagawa, Japan
Local Institution - 0262
🇯🇵Yokohama-shi, Kanagawa, Japan
Local Institution - 0189
🇯🇵Kyoto-shi, Kyoto, Japan
Local Institution - 0261
🇯🇵Kashihara City, Nara, Japan
Local Institution - 0263
🇯🇵Abeno-ku, Osaka, Japan
Local Institution - 0281
🇯🇵Saga Shi, Saga, Japan
Local Institution - 0258
🇯🇵Iruma-gun, Saitama, Japan
Local Institution - 0127
🇯🇵Osakasayama, Osaka, Japan
Local Institution - 0259
🇯🇵Izunokuni-shi, Shizuoka, Japan
Local Institution - 0204
🇯🇵Chiba, Japan
Local Institution - 0122
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0062
🇰🇷Jongno-gu, Seoul, Korea, Republic of
Local Institution - 0143
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Local Institution - 0178
🇯🇵Fukuoka, Japan
Local Institution - 0177
🇯🇵Hiroshima, Japan
Local Institution - 0167
🇰🇷Guro-gu, Seoul, Korea, Republic of
Local Institution - 0097
🇰🇷Gyeonggi-do, Korea, Republic of
Local Institution - 0155
🇯🇵Sapporo, Japan
Local Institution - 0141
🇰🇷Seoul, Korea, Republic of
Local Institution - 0098
🇰🇷Gyeongsangnam-do, Korea, Republic of
Local Institution - 0139
🇰🇷Seoul, Korea, Republic of
Local Institution - 0286
🇳🇿Christchurch, Canterbury, New Zealand
Local Institution - 0047
🇳🇿Auckland, New Zealand
Local Institution - 0289
🇵🇷Rio Piedras, Puerto Rico
Local Institution - 0035
🇵🇷San Juan, Puerto Rico
Local Institution - 0148
🇵🇱Gdansk, Poland
Local Institution - 0163
🇷🇴Timisoara, Romania
Local Institution - 0049
🇵🇱Otwock, Poland
Local Institution - 0029
🇷🇺Arkhangelsk, Russian Federation
Local Institution - 0066
🇷🇺Barnaul, Russian Federation
Local Institution - 0074
🇷🇺Chelyabinsk, Russian Federation
Local Institution - 0007
🇷🇺Moscow, Russian Federation
Local Institution - 0073
🇷🇺Sochi, Russian Federation
Local Institution - 0048
🇸🇬Singapore, Singapore
Local Institution - 0091
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0297
🇪🇸Barcelona, Spain
Local Institution - 0072
🇷🇺Pyatigorsk, Russian Federation
Local Institution - 0174
🇸🇬Singapore, Singapore
Local Institution - 0055
🇪🇸Barcelona, Spain
Local Institution - 0017
🇸🇬Singapore, Singapore
Local Institution - 0089
🇪🇸Barcelona, Spain
Local Institution - 0041
🇪🇸Madrid, Spain
Local Institution - 0045
🇪🇸Majadahonda, Spain
Local Institution - 0290
🇪🇸Madrid, Spain
Local Institution - 0090
🇪🇸Cordoba, Spain
Local Institution - 0087
🇪🇸El Palmar, Spain
Local Institution - 0093
🇪🇸Madrid, Spain
Local Institution - 0088
🇪🇸Santander, Spain
Local Institution - 0040
🇪🇸Zaragoza, Spain
Local Institution - 0272
🇨🇳Kaohsiung, Taiwan
Local Institution - 0085
🇪🇸Pamplona, Spain
Local Institution - 0078
🇨🇳Taipei, Taiwan
Local Institution - 0144
🇨🇳Taipei, Taiwan
Local Institution - 0105
🇨🇳Taichung, Taiwan
Local Institution - 0154
🇬🇧Guildford, Surrey, United Kingdom
Local Institution - 0160
🇬🇧Edinburgh, United Kingdom
Local Institution - 0171
🇬🇧London, Greater London, United Kingdom
Local Institution - 0304
🇺🇸Dallas, Texas, United States
Local Institution - 0108
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0288
🇺🇸Coronado, California, United States
Local Institution - 0142
🇰🇷Busan, Korea, Republic of
Local Institution - 0002
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0307
🇨🇳Xi'an, Shan3xi, China
Local Institution - 0069
🇫🇷Clichy, France
Local Institution - 0292
🇺🇸Tucson, Arizona, United States
Local Institution - 0157
🇺🇸Duarte, California, United States
Local Institution - 0190
🇺🇸Baltimore, Maryland, United States
Local Institution - 0027
🇺🇸Louisville, Kentucky, United States
Local Institution - 0077
🇺🇸Washington, District of Columbia, United States
Local Institution - 0194
🇦🇷Pilar Provincia De Buenos Aires, Buenos Aires, Argentina
Local Institution - 0099
🇧🇪Haine-Saint-Paul, Belgium
Local Institution - 0019
🇦🇺Clayton, Victoria, Australia
Local Institution - 0192
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0145
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0082
🇫🇷Montpellier, France
Local Institution - 0140
🇰🇷Seoul, Korea, Republic of
Local Institution - 0092
🇵🇱Warszawa, Poland
Local Institution - 0103
🇷🇴Craiova, Dolj, Romania
Local Institution - 0075
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0270
🇨🇳Tainan, Taiwan
Local Institution - 0129
🇬🇧London, United Kingdom
Local Institution - 0036
🇭🇰Hong Kong, Hong Kong
Local Institution - 0032
🇭🇰Hong Kong, Hong Kong