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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab + Ipilimumab | Experimental |
| |
| Sorafenib/lenvatinib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Participants will receive nivolumab as intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to 4 years | |
| Duration of Response (DOR) | Up to 4 years | |
| Time to Symptom Deterioration (TTSD) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0292 | Tucson | Arizona | 85719 | United States | ||
| Local Institution - 0288 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41981891 | Derived | Yau T, Galle PR, Decaens T, Sangro B, Qin S, da Fonseca LG, Karachiwala H, Blanc JF, Park JW, Gane E, Pinter M, Matilla Pena A, Ikeda M, Tai D, Santoro A, Pizarro G, Chiu CF, Schenker M, He A, Chon HJ, Wojcik-Tomaszewska J, Verset G, Wang QQ, Stromko C, Neely J, Singh P, Jimenez Exposito MJ, Kudo M. A plain language summary of the CheckMate 9DW study: nivolumab in combination with ipilimumab for unresectable hepatocellular carcinoma (advanced liver cancer). Future Oncol. 2026 Apr;22(10):1135-1152. doi: 10.1080/14796694.2026.2651375. Epub 2026 Apr 14. | |
| 40349714 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Ipilimumab | Drug | Participants will receive ipilimumab as IV infusion. |
|
| Sorafenib | Drug | Participants will receive sorafenib as oral tablets. |
|
| lenvatinib | Drug | Participants will receive lenvatinib as oral capsules. |
|
| Up to 4 years |
| Coronado |
| California |
| 92118 |
| United States |
| Local Institution - 0157 | Duarte | California | 91010-3012 | United States |
| Local Institution - 0077 | Washington D.C. | District of Columbia | 20007 | United States |
| Local Institution - 0027 | Louisville | Kentucky | 40217 | United States |
| Local Institution - 0190 | Baltimore | Maryland | 21287 | United States |
| Local Institution | Ann Arbor | Michigan | 48105 | United States |
| Local Institution - 0018 | Detroit | Michigan | 48202 | United States |
| Local Institution - 0295 | Newark | New Jersey | 07103 | United States |
| Local Institution - 0043 | Toledo | Ohio | 43623 | United States |
| Local Institution - 0284 | Pittsburgh | Pennsylvania | 15212 | United States |
| Local Institution - 0304 | Dallas | Texas | 75203 | United States |
| Local Institution - 0202 | Houston | Texas | 77030 | United States |
| Local Institution - 0046 | Lubbock | Texas | 79410 | United States |
| Local Institution - 0172 | Salt Lake City | Utah | 84106 | United States |
| Local Institution - 0037 | Caba | Buenos Aires | C1090AAS | Argentina |
| Local Institution - 0194 | Pilar | Buenos Aires | B1629ODT | Argentina |
| Local Institution - 0282 | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution - 0136 | Buenos Aires | C1426ANZ | Argentina |
| Local Institution - 0058 | San Miguel de Tucumán | 4000 | Argentina |
| Local Institution - 0003 | Kogarah | New South Wales | 2217 | Australia |
| Local Institution - 0038 | Liverpool | New South Wales | 1871 | Australia |
| Local Institution - 0002 | Westmead | New South Wales | 2145 | Australia |
| Local Institution - 0004 | Birtinya | Queensland | 4560 | Australia |
| Local Institution - 0013 | Herston | Queensland | 4029 | Australia |
| Local Institution - 0009 | Adelaide | South Australia | 5000 | Australia |
| Local Institution - 0019 | Clayton | Victoria | 3168 | Australia |
| Local Institution - 0026 | Fitzroy | Victoria | 3065 | Australia |
| Local Institution - 0001 | Melbourne | Victoria | 3004 | Australia |
| Local Institution - 0020 | St Albans | Victoria | 3021 | Australia |
| Local Institution - 0114 | Sankt Pölten | Lower Austria | 3100 | Austria |
| Local Institution - 0057 | Wiener Neustadt | Lower Austria | 2700 | Austria |
| Local Institution - 0188 | Graz | 8036 | Austria |
| Local Institution - 0065 | Klagenfurt | 9020 | Austria |
| Local Institution - 0186 | Vienna | 1090 | Austria |
| Local Institution - 0034 | Brussels | 1070 | Belgium |
| Local Institution - 0008 | Federal District | 72115700 | Belgium |
| Local Institution - 0124 | Ghent | 9000 | Belgium |
| Local Institution - 0298 | Ghent | 9000 | Belgium |
| Local Institution - 0099 | Haine-Saint-Paul | 7100 | Belgium |
| Local Institution - 0064 | Leuven | 3000 | Belgium |
| Local Institution - 0104 | Liège | 4000 | Belgium |
| Local Institution - 0278 | Vitória | Espírito Santo | 29055-450 | Brazil |
| Local Institution | Salvador | Estado de Bahia | 41253190 | Brazil |
| Local Institution - 0061 | Salvador | Estado de Bahia | 41950-640 | Brazil |
| Local Institution - 0181 | Brasília | Federal District | 70200-730 | Brazil |
| Local Institution - 0279 | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Local Institution - 0060 | Pelotas | Rio Grande do Sul | 96020-360 | Brazil |
| Local Institution - 0054 | Jaú | São Paulo | 17210-120 | Brazil |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Local Institution - 0016 | Paranã | 81520-060 | Brazil |
| Local Institution - 0015 | Rio de Janeiro | 22793-080 | Brazil |
| Local Institution - 0023 | São Paulo | 01246-000 | Brazil |
| Local Institution - 0022 | São Paulo | 01323-900 | Brazil |
| Local Institution - 0050 | São Paulo | 04038-034 | Brazil |
| Local Institution - 0192 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0296 | Temuco | Araucania | 4780000 | Chile |
| Local Institution - 0094 | La Serena | Coquimbo Region | 1720430 | Chile |
| Local Institution - 0283 | Santiago | RM | 7630372 | Chile |
| Local Institution - 0095 | Santiago | Santiago Metropolitan | 0 | Chile |
| Local Institution - 0024 | Santiago | Santiago Metropolitan | 7710007 | Chile |
| Local Institution - 0156 | Santiago | Santiago Metropolitan | 8380456 | Chile |
| Local Institution - 0012 | Viña del Mar | Valparaiso | 2520598 | Chile |
| Local Institution - 0216 | Viña del Mar | Valparaiso | 2540402 | Chile |
| Local Institution - 0120 | Hefei | Anhui | 230022 | China |
| Local Institution - 0146 | Hefei | Anhui | 230601 | China |
| Local Institution - 0175 | Beijing | Beijing Municipality | 100000 | China |
| Local Institution - 0152 | Beijing | Beijing Municipality | 100142 | China |
| Local Institution - 0151 | Fuzhou | Fujian | 350002 | China |
| Local Institution - 0121 | Fuzhou | Fujian | 350014 | China |
| Local Institution - 0125 | Guangzhou | Guangdong | 510000 | China |
| Local Institution - 0150 | Guangzhou | Guangdong | 510515 | China |
| Local Institution - 0135 | Harbin | Heilongjiang | 150081 | China |
| Local Institution - 0109 | Changsha | Hunan | 410006 | China |
| Local Institution - 0059 | Changsha | Hunan | 410011 | China |
| Local Institution - 0130 | Nanjing | Jiangsu | 210002 | China |
| Local Institution - 0145 | Nanchang | Jiangxi | 330006 | China |
| Local Institution - 0149 | Nanchang | Jiangxi | 330019 | China |
| Local Institution - 0162 | Changchun | Jilin | 130021 | China |
| Local Institution - 0166 | Changchun | Jilin | 130102 | China |
| Local Institution - 0131 | Dalian | Liaoning | 116023 | China |
| Local Institution - 0123 | Shenyang | Liaoning | 110004 | China |
| Local Institution - 0132 | Shenyang | Liaoning | 110117 | China |
| Local Institution - 0133 | Xi'an | Shaanxi | 710038 | China |
| Local Institution - 0147 | Xi'an | Shan3xi | 710061 | China |
| Local Institution - 0307 | Xi'an | Shan3xi | 710100 | China |
| Local Institution - 0153 | Qingdao | Shandong | 266000 | China |
| Local Institution - 0134 | Shanghai | Shanghai Municipality | 200032 | China |
| Local Institution - 0179 | Chongqing | Sichuan | 400030 | China |
| Local Institution - 0108 | Hangzhou | Zhejiang | 310000 | China |
| Local Institution - 0107 | Hangzhou | Zhejiang | 310022 | China |
| Local Institution - 0274 | Prague | Prague | 14059 | Czechia |
| Local Institution | Brno | 60200 | Czechia |
| Local Institution - 0068 | Amiens | 80054 | France |
| Local Institution - 0116 | Caen | 14033 | France |
| Local Institution - 0069 | Clichy | 92110 | France |
| Local Institution - 0138 | Dijon | 21000 | France |
| Local Institution - 0081 | Grenoble | 38043 | France |
| Local Institution - 0070 | Lyon | 69004 | France |
| Local Institution | Marseille | 13009 | France |
| Local Institution - 0082 | Montpellier | 34295 | France |
| Local Institution - 0067 | Nice | 6202 | France |
| Local Institution - 0025 | Pessac | 33604 | France |
| Local Institution - 0137 | Poitiers | 86021 | France |
| Local Institution - 0042 | Toulouse | 31059 | France |
| Local Institution - 0071 | Vandœuvre-lès-Nancy | 54500 | France |
| Local Institution - 0051 | Villejuif | 94800 | France |
| Local Institution - 0005 | Frankfurt am Main | Hesse | 60590 | Germany |
| Local Institution - 0231 | Bonn | 53127 | Germany |
| Local Institution - 0028 | Cologne | 50937 | Germany |
| Local Institution - 0052 | Essen | 45147 | Germany |
| Local Institution - 0185 | Freiburg im Breisgau | 79106 | Germany |
| Local Institution - 0006 | Hamburg | 20246 | Germany |
| Local Institution - 0102 | Hanover | 30625 | Germany |
| Local Institution - 0118 | Leipzig | 04103 | Germany |
| Local Institution - 0031 | Mainz | 55131 | Germany |
| Local Institution - 0056 | Mannheim | 68167 | Germany |
| Local Institution | München | 81675 | Germany |
| Local Institution - 0053 | North Rhine-Westphalia | 45136 | Germany |
| Local Institution - 0036 | Hong Kong | 999077 | Hong Kong |
| Local Institution - 0032 | Hong Kong | Hong Kong |
| Local Institution - 0110 | Meldola | Forli-Cesena | 47014 | Italy |
| Local Institution - 0101 | Rozzano | Milano | 20089 | Italy |
| Local Institution - 0084 | Candiolo | 10060 | Italy |
| Local Institution - 0039 | Milan | 20122 | Italy |
| Local Institution - 0100 | Novara | 28100 | Italy |
| Local Institution - 0219 | Padova | 35128 | Italy |
| Local Institution - 0033 | Parma | 43126 | Italy |
| Local Institution - 0112 | Roma | 00128 | Italy |
| Local Institution - 0079 | Rome | 00168 | Italy |
| Local Institution - 0111 | Siena | 53100 | Italy |
| Local Institution - 0044 | Vicenza | 36100 | Italy |
| Local Institution - 0193 | Kashiwa-shi | Chiba | 2778577 | Japan |
| Local Institution - 0203 | Matsuyama | Ehime | 790-0024 | Japan |
| Local Institution - 0176 | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Local Institution - 0200 | Yokohama | Kanagawa | 2320024 | Japan |
| Local Institution - 0262 | Yokohama | Kanagawa | 241-8515 | Japan |
| Local Institution - 0189 | Kyoto | Kyoto | 602-8566 | Japan |
| Local Institution - 0261 | Kashihara | Nara | 634-8522 | Japan |
| Local Institution - 0263 | Abeno-ku | Osaka | 5458586 | Japan |
| Local Institution - 0127 | Sayama | Osaka | 5898511 | Japan |
| Local Institution - 0281 | Saga | Saga-ken | 8408571 | Japan |
| Local Institution - 0258 | Iruma-gun | Saitama | 3500495 | Japan |
| Local Institution - 0259 | Izunokuni-shi | Shizuoka | 410-2295 | Japan |
| Local Institution - 0128 | Minato | Tokyo | 105-8470 | Japan |
| Local Institution - 0122 | Minato-ku | Tokyo | 105-8470 | Japan |
| Local Institution - 0201 | Mitaka | Tokyo | 181-8611 | Japan |
| Local Institution - 0199 | Musashino-shi | Tokyo | 180-8610 | Japan |
| Local Institution - 0204 | Chiba | 260-8677 | Japan |
| Local Institution - 0178 | Fukuoka | 830-0011 | Japan |
| Local Institution - 0177 | Hiroshima | 7348551 | Japan |
| Local Institution - 0155 | Sapporo | 0600033 | Japan |
| Local Institution - 0286 | Christchurch | Canterbury | 8011 | New Zealand |
| Local Institution - 0047 | Auckland | 1023 | New Zealand |
| Local Institution - 0148 | Gdansk | 80219 | Poland |
| Local Institution - 0049 | Otwock | 05-400 | Poland |
| Local Institution - 0092 | Warsaw | 02-034 | Poland |
| Local Institution - 0289 | Rio Piedras | 00935 | Puerto Rico |
| Local Institution - 0035 | San Juan | 00927-4308 | Puerto Rico |
| Local Institution - 0103 | Craiova | Dolj | 200542 | Romania |
| Local Institution - 0164 | Bucharest | 022328 | Romania |
| Local Institution - 0165 | Cluj-Napoca | 400015 | Romania |
| Local Institution | Craiova | 200385 | Romania |
| Local Institution - 0163 | Timișoara | 300166 | Romania |
| Local Institution - 0029 | Arkhangelsk | 163045 | Russia |
| Local Institution - 0066 | Barnaul | 656045 | Russia |
| Local Institution - 0074 | Chelyabinsk | 454087 | Russia |
| Local Institution - 0007 | Moscow | 115478 | Russia |
| Local Institution - 0072 | Pyatigorsk | 357502 | Russia |
| Local Institution - 0075 | Saint Petersburg | 197758 | Russia |
| Local Institution - 0091 | Saint Petersburg | 198255 | Russia |
| Local Institution - 0073 | Sochi | 354057 | Russia |
| Local Institution - 0048 | Singapore | 168583 | Singapore |
| Local Institution - 0017 | Singapore | 258499 | Singapore |
| Local Institution - 0174 | Singapore | 308442 | Singapore |
| Local Institution - 0143 | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Local Institution - 0167 | Guro-gu | Seoul | 8308 | South Korea |
| Local Institution - 0062 | Jongno-gu | Seoul | 03080 | South Korea |
| Local Institution - 0142 | Busan | 49241 | South Korea |
| Local Institution - 0097 | Gyeonggi-do | 010408 | South Korea |
| Local Institution - 0098 | Gyeongsangnam-do | 050612 | South Korea |
| Local Institution - 0141 | Seoul | 03722 | South Korea |
| Local Institution - 0140 | Seoul | 05505 | South Korea |
| Local Institution - 0139 | Seoul | 06351 | South Korea |
| Local Institution - 0297 | Barcelona | 08035 | Spain |
| Local Institution - 0055 | Barcelona | 08036 | Spain |
| Local Institution - 0089 | Barcelona | 08908 | Spain |
| Local Institution - 0090 | Córdoba | 14004 | Spain |
| Local Institution - 0087 | El Palmar | 30120 | Spain |
| Local Institution - 0041 | Madrid | 28007 | Spain |
| Local Institution - 0093 | Madrid | 28028 | Spain |
| Local Institution - 0290 | Madrid | 28035 | Spain |
| Local Institution - 0045 | Majadahonda | 28222 | Spain |
| Local Institution - 0085 | Pamplona | 31008 | Spain |
| Local Institution - 0088 | Santander | 39008 | Spain |
| Local Institution - 0040 | Zaragoza | 50009 | Spain |
| Local Institution - 0063 | Bern | 3010 | Switzerland |
| Local Institution - 0272 | Kaohsiung City | 807 | Taiwan |
| Local Institution - 0096 | Kaohsiung City | 83301 | Taiwan |
| Local Institution - 0105 | Taichung | 40447 | Taiwan |
| Local Institution - 0271 | Taichung | 40705 | Taiwan |
| Local Institution - 0168 | Tainan | 704 | Taiwan |
| Local Institution - 0270 | Tainan | 736 | Taiwan |
| Local Institution - 0144 | Taipei | 10002 | Taiwan |
| Local Institution - 0078 | Taipei | 11266 | Taiwan |
| Local Institution - 0173 | Taoyuan | 333 | Taiwan |
| Local Institution - 0171 | London | Greater London | W12 OHS | United Kingdom |
| Local Institution - 0154 | Guildford | Surrey | GU2 7XX | United Kingdom |
| Local Institution - 0160 | Edinburgh | EH4 2XU | United Kingdom |
| Local Institution - 0129 | London | SE5 9RS | United Kingdom |
| Derived |
| Yau T, Galle PR, Decaens T, Sangro B, Qin S, da Fonseca LG, Karachiwala H, Blanc JF, Park JW, Gane E, Pinter M, Pena AM, Ikeda M, Tai D, Santoro A, Pizarro G, Chiu CF, Schenker M, He A, Chon HJ, Wojcik-Tomaszewska J, Verset G, Wang QQ, Stromko C, Neely J, Singh P, Jimenez Exposito MJ, Kudo M; CheckMate 9DW investigators. Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial. Lancet. 2025 May 24;405(10492):1851-1864. doi: 10.1016/S0140-6736(25)00403-9. Epub 2025 May 8. |
| 38038862 | Derived | Huynh JC, Cho M, Monjazeb A, Al-Obeidi E, Singh A, Tam K, Lara F, Martinez A, Garcia L, Kim EJ. Phase I/II trial of BMS-986,205 and nivolumab as first line therapy in hepatocellular carcinoma. Invest New Drugs. 2024 Feb;42(1):35-43. doi: 10.1007/s10637-023-01416-w. Epub 2023 Dec 1. |
| BMS Clinical Trial Patient Recruiting | View source |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| D000077157 | Sorafenib |
| C531958 | lenvatinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
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