NCT04039607CompletedPhase 3
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
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
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 732 (actual)
- First submitted
- 30 Jul 2019
- Start date
- 30 Sept 2019
- Primary completion date
- 9 Jul 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04039607
- EU CT number
- 2023-508635-31-00
- EudraCT number
- 2019-000252-34
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 732
- From 30 Sept 2019 to the primary completion date, 9 Jul 2026
- 175 sites in 26 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior liver transplant
- Episodes of hepatic encephalopathy (greater than or equal to \[\>=\] Grade 2) within 12 months prior to randomization
Other
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Active brain metastases or leptomeningeal metastases
- Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (175)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0136 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Caba | Argentina | Unknown status |
| Local Institution - 0194 Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| Local Institution - 0282 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Local Institution - 0058 Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Birtinya | Australia | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Local Institution - 0038 Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | St Albans | Australia | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| Local Institution - 0181 Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Local Institution - 0279 Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Jaú | Brazil | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Paranã | Brazil | Unknown status |
| Local Institution - 0060 Coordinator of this site? Confirm its status | Pelotas | Brazil | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Hospital de Base de Sao Jose do Rio Preto Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0023 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0278 Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Local Institution - 0192 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Local Institution - 0063 Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Local Institution - 0094 Coordinator of this site? Confirm its status | La Serena | Chile | Unknown status |
| Local Institution - 0283 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0095 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0156 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0296 Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Local Institution - 0216 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Local Institution - 0152 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0175 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0162 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0166 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0109 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0059 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0179 Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Local Institution - 0151 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0121 Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0150 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0108 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0107 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Local Institution - 0146 Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Local Institution - 0145 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Local Institution - 0149 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0153 Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0123 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Local Institution - 0307 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution - 0147 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution - 0133 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Local Institution - 0274 Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Johannes Gutenberg University Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| Hopital De La Croix-Rousse Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Completed |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Hopital Paul Brousse Coordinator of this site? Confirm its status | Villejuif Cedex | France | Completed |
| Local Institution - 0160 Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Local Institution - 0154 Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0171 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| Azienda Unita Locale Socio Sanitaria N 8 Berica Coordinator of this site? Confirm its status | Vicenza | Italy | Completed |
| Local Institution - 0263 Coordinator of this site? Confirm its status | Abeno-ku | Japan | Unknown status |
| Local Institution - 0204 Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Local Institution - 0178 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Local Institution - 0177 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 0258 Coordinator of this site? Confirm its status | Iruma-gun | Japan | Unknown status |
| Local Institution - 0259 Coordinator of this site? Confirm its status | Izunokuni-shi | Japan | Unknown status |
| Local Institution - 0176 Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Local Institution - 0261 Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Local Institution - 0193 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Local Institution - 0189 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Local Institution - 0203 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Minato | Japan | Unknown status |
| Local Institution - 0122 Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Local Institution - 0201 Coordinator of this site? Confirm its status | Mitaka | Japan | Unknown status |
| Local Institution - 0199 Coordinator of this site? Confirm its status | Musashino-shi | Japan | Unknown status |
| Local Institution - 0281 Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| Local Institution - 0155 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Sayama | Japan | Unknown status |
| Local Institution - 0200 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0262 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Local Institution - 0142 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Local Institution - 0167 Coordinator of this site? Confirm its status | Guro-gu | South Korea | Unknown status |
| Local Institution - 0097 Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Gyeongsangnam-do | South Korea | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Jongno-gu | South Korea | Unknown status |
| Local Institution - 0143 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Local Institution - 0141 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0139 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Local Institution - 0286 Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Europejskie Centrum Zdrowia Otwock Sp. Z.o.o. Coordinator of this site? Confirm its status | Otwock | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Local Institution - 0289 Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Arkhangelsk | Russia | Unknown status |
| Local Institution - 0066 Coordinator of this site? Confirm its status | Barnaul | Russia | Unknown status |
| Local Institution - 0074 Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0072 Coordinator of this site? Confirm its status | Pyatigorsk | Russia | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Local Institution - 0073 Coordinator of this site? Confirm its status | Sochi | Russia | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0174 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0272 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Local Institution - 0096 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Local Institution - 0105 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0271 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0168 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0270 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0144 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0173 Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Local Institution - 0190 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Local Institution - 0288 Coordinator of this site? Confirm its status | Coronado | United States | Unknown status |
| Local Institution - 0304 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Local Institution - 0157 Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Local Institution - 0202 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Local Institution - 0046 Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Local Institution - 0295 Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Local Institution - 0284 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Local Institution - 0172 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Local Institution - 0292 Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
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