A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Bristol-Myers Squibb
Sponsor
Bristol-Myers Squibb
Information Provided by (Responsible Party)
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
NCT04039607
Other Study ID Numbers:
CA209-9DW
First Submitted
July 29, 2019
First Posted
July 30, 2019
Last Update Posted
April 5, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Hepatocellular Carcinoma
Drug: NivolumabDrug: Sorafenib

Study Design

Study TypeInterventional
Actual Enrollment732 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateSeptember 29, 2019
Actual Primary Completion Date1mo 1w from now
Actual Study Completion Date1mo 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Nivolumab + Ipilimumab
Drug: Nivolumab
Participants will receive nivolumab as intravenous (IV) infusion.
Sorafenib/lenvatinib
Drug: Sorafenib
Participants will receive sorafenib as oral tablets.

Outcome Measures

Primary Outcome Measures
  1. Overall Survival (OS)
Secondary Outcome Measures
  1. Objective Response Rate (ORR)
  2. Duration of Response (DOR)
  3. Time to Symptom Deterioration (TTSD)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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
Exclusion Criteria
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.

Contacts and Locations

Sponsors and CollaboratorsBristol-Myers Squibb
Locations
Local Institution - 0292 | Tucson Arizona, United States, 85719Local Institution - 0288 | Coronado California, United States, 92118Local Institution - 0157 | Duarte California, United States, 91010-3012Local Institution - 0077 | Washington D.C. District of Columbia, United States, 20007Local Institution - 0027 | Louisville Kentucky, United States, 40217Local Institution - 0190 | Baltimore Maryland, United States, 21287Local Institution | Ann Arbor Michigan, United States, 48105Local Institution - 0018 | Detroit Michigan, United States, 48202Local Institution - 0295 | Newark New Jersey, United States, 07103Local Institution - 0043 | Toledo Ohio, United States, 43623Local Institution - 0284 | Pittsburgh Pennsylvania, United States, 15212Local Institution - 0304 | Dallas Texas, United States, 75203Local Institution - 0202 | Houston Texas, United States, 77030Local Institution - 0046 | Lubbock Texas, United States, 79410Local Institution - 0172 | Salt Lake City Utah, United States, 84106Local Institution - 0037 | Caba Buenos Aires, Argentina, C1090AASLocal Institution - 0194 | Pilar Buenos Aires, Argentina, B1629ODTLocal Institution - 0282 | Rosario Santa Fe Province, Argentina, 2000Local Institution - 0136 | Buenos Aires , Argentina, C1426ANZLocal Institution - 0058 | San Miguel de Tucumán , Argentina, 4000Local Institution - 0003 | Kogarah New South Wales, Australia, 2217Local Institution - 0038 | Liverpool New South Wales, Australia, 1871Local Institution - 0002 | Westmead New South Wales, Australia, 2145Local Institution - 0004 | Birtinya Queensland, Australia, 4560Local Institution - 0013 | Herston Queensland, Australia, 4029Local Institution - 0009 | Adelaide South Australia, Australia, 5000Local Institution - 0019 | Clayton Victoria, Australia, 3168Local Institution - 0026 | Fitzroy Victoria, Australia, 3065Local Institution - 0001 | Melbourne Victoria, Australia, 3004Local Institution - 0020 | St Albans Victoria, Australia, 3021Local Institution - 0114 | Sankt Pölten Lower Austria, Austria, 3100Local Institution - 0057 | Wiener Neustadt Lower Austria, Austria, 2700Local Institution - 0188 | Graz , Austria, 8036Local Institution - 0065 | Klagenfurt , Austria, 9020Local Institution - 0186 | Vienna , Austria, 1090Local Institution - 0034 | Brussels , Belgium, 1070Local Institution - 0008 | Federal District , Belgium, 72115700Local Institution - 0124 | Ghent , Belgium, 9000Local Institution - 0298 | Ghent , Belgium, 9000Local Institution - 0099 | Haine-Saint-Paul , Belgium, 7100Local Institution - 0064 | Leuven , Belgium, 3000Local Institution - 0104 | Liège , Belgium, 4000Local Institution - 0278 | Vitória Espírito Santo, Brazil, 29055-450Local Institution | Salvador Estado de Bahia, Brazil, 41253190Local Institution - 0061 | Salvador Estado de Bahia, Brazil, 41950-640Local Institution - 0181 | Brasília Federal District, Brazil, 70200-730Local Institution - 0279 | Ijuí Rio Grande do Sul, Brazil, 98700-000Local Institution - 0060 | Pelotas Rio Grande do Sul, Brazil, 96020-360Local Institution - 0054 | Jaú São Paulo, Brazil, 17210-120Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto São Paulo, Brazil, 15090-000Local Institution - 0016 | Paranã , Brazil, 81520-060Local Institution - 0015 | Rio de Janeiro , Brazil, 22793-080Local Institution - 0023 | São Paulo , Brazil, 01246-000Local Institution - 0022 | São Paulo , Brazil, 01323-900Local Institution - 0050 | São Paulo , Brazil, 04038-034Local Institution - 0192 | Edmonton Alberta, Canada, T6G 1Z2Local Institution - 0296 | Temuco Araucania, Chile, 4780000Local Institution - 0094 | La Serena Coquimbo Region, Chile, 1720430Local Institution - 0283 | Santiago RM, Chile, 7630372Local Institution - 0095 | Santiago Santiago Metropolitan, Chile, 0Local Institution - 0024 | Santiago Santiago Metropolitan, Chile, 7710007Local Institution - 0156 | Santiago Santiago Metropolitan, Chile, 8380456Local Institution - 0012 | Viña del Mar Valparaiso, Chile, 2520598Local Institution - 0216 | Viña del Mar Valparaiso, Chile, 2540402Local Institution - 0120 | Hefei Anhui, China, 230022Local Institution - 0146 | Hefei Anhui, China, 230601Local Institution - 0175 | Beijing Beijing Municipality, China, 100000Local Institution - 0152 | Beijing Beijing Municipality, China, 100142Local Institution - 0151 | Fuzhou Fujian, China, 350002Local Institution - 0121 | Fuzhou Fujian, China, 350014Local Institution - 0125 | Guangzhou Guangdong, China, 510000Local Institution - 0150 | Guangzhou Guangdong, China, 510515Local Institution - 0135 | Harbin Heilongjiang, China, 150081Local Institution - 0109 | Changsha Hunan, China, 410006Local Institution - 0059 | Changsha Hunan, China, 410011Local Institution - 0130 | Nanjing Jiangsu, China, 210002Local Institution - 0145 | Nanchang Jiangxi, China, 330006Local Institution - 0149 | Nanchang Jiangxi, China, 330019Local Institution - 0162 | Changchun Jilin, China, 130021Local Institution - 0166 | Changchun Jilin, China, 130102Local Institution - 0131 | Dalian Liaoning, China, 116023Local Institution - 0123 | Shenyang Liaoning, China, 110004Local Institution - 0132 | Shenyang Liaoning, China, 110117Local Institution - 0133 | Xi'an Shaanxi, China, 710038Local Institution - 0147 | Xi'an Shan3xi, China, 710061Local Institution - 0307 | Xi'an Shan3xi, China, 710100Local Institution - 0153 | Qingdao Shandong, China, 266000Local Institution - 0134 | Shanghai Shanghai Municipality, China, 200032Local Institution - 0179 | Chongqing Sichuan, China, 400030Local Institution - 0108 | Hangzhou Zhejiang, China, 310000Local Institution - 0107 | Hangzhou Zhejiang, China, 310022Local Institution - 0274 | Prague Prague, Czechia, 14059Local Institution | Brno , Czechia, 60200Local Institution - 0068 | Amiens , France, 80054Local Institution - 0116 | Caen , France, 14033Local Institution - 0069 | Clichy , France, 92110Local Institution - 0138 | Dijon , France, 21000Local Institution - 0081 | Grenoble , France, 38043Local Institution - 0070 | Lyon , France, 69004Local Institution | Marseille , France, 13009Local Institution - 0082 | Montpellier , France, 34295Local Institution - 0067 | Nice , France, 6202Local Institution - 0025 | Pessac , France, 33604Local Institution - 0137 | Poitiers , France, 86021Local Institution - 0042 | Toulouse , France, 31059Local Institution - 0071 | Vandœuvre-lès-Nancy , France, 54500Local Institution - 0051 | Villejuif , France, 94800Local Institution - 0005 | Frankfurt am Main Hesse, Germany, 60590Local Institution - 0231 | Bonn , Germany, 53127Local Institution - 0028 | Cologne , Germany, 50937Local Institution - 0052 | Essen , Germany, 45147Local Institution - 0185 | Freiburg im Breisgau , Germany, 79106Local Institution - 0006 | Hamburg , Germany, 20246Local Institution - 0102 | Hanover , Germany, 30625Local Institution - 0118 | Leipzig , Germany, 04103Local Institution - 0031 | Mainz , Germany, 55131Local Institution - 0056 | Mannheim , Germany, 68167Local Institution | München , Germany, 81675Local Institution - 0053 | North Rhine-Westphalia , Germany, 45136Local Institution - 0036 | Hong Kong , Hong Kong, 999077Local Institution - 0032 | Hong Kong , Hong Kong, Local Institution - 0110 | Meldola Forli-Cesena, Italy, 47014Local Institution - 0101 | Rozzano Milano, Italy, 20089Local Institution - 0084 | Candiolo , Italy, 10060Local Institution - 0039 | Milan , Italy, 20122Local Institution - 0100 | Novara , Italy, 28100Local Institution - 0219 | Padova , Italy, 35128Local Institution - 0033 | Parma , Italy, 43126Local Institution - 0112 | Roma , Italy, 00128Local Institution - 0079 | Rome , Italy, 00168Local Institution - 0111 | Siena , Italy, 53100Local Institution - 0044 | Vicenza , Italy, 36100Local Institution - 0193 | Kashiwa-shi Chiba, Japan, 2778577Local Institution - 0203 | Matsuyama Ehime, Japan, 790-0024Local Institution - 0176 | Kanazawa Ishikawa-ken, Japan, 920-8641Local Institution - 0200 | Yokohama Kanagawa, Japan, 2320024Local Institution - 0262 | Yokohama Kanagawa, Japan, 241-8515Local Institution - 0189 | Kyoto Kyoto, Japan, 602-8566Local Institution - 0261 | Kashihara Nara, Japan, 634-8522Local Institution - 0263 | Abeno-ku Osaka, Japan, 5458586Local Institution - 0127 | Sayama Osaka, Japan, 5898511Local Institution - 0281 | Saga Saga-ken, Japan, 8408571Local Institution - 0258 | Iruma-gun Saitama, Japan, 3500495Local Institution - 0259 | Izunokuni-shi Shizuoka, Japan, 410-2295Local Institution - 0128 | Minato Tokyo, Japan, 105-8470Local Institution - 0122 | Minato-ku Tokyo, Japan, 105-8470Local Institution - 0201 | Mitaka Tokyo, Japan, 181-8611Local Institution - 0199 | Musashino-shi Tokyo, Japan, 180-8610Local Institution - 0204 | Chiba , Japan, 260-8677Local Institution - 0178 | Fukuoka , Japan, 830-0011Local Institution - 0177 | Hiroshima , Japan, 7348551Local Institution - 0155 | Sapporo , Japan, 0600033Local Institution - 0286 | Christchurch Canterbury, New Zealand, 8011Local Institution - 0047 | Auckland , New Zealand, 1023Local Institution - 0148 | Gdansk , Poland, 80219Local Institution - 0049 | Otwock , Poland, 05-400Local Institution - 0092 | Warsaw , Poland, 02-034Local Institution - 0289 | Rio Piedras , Puerto Rico, 00935Local Institution - 0035 | San Juan , Puerto Rico, 00927-4308Local Institution - 0103 | Craiova Dolj, Romania, 200542Local Institution - 0164 | Bucharest , Romania, 022328Local Institution - 0165 | Cluj-Napoca , Romania, 400015Local Institution | Craiova , Romania, 200385Local Institution - 0163 | Timișoara , Romania, 300166Local Institution - 0029 | Arkhangelsk , Russia, 163045Local Institution - 0066 | Barnaul , Russia, 656045Local Institution - 0074 | Chelyabinsk , Russia, 454087Local Institution - 0007 | Moscow , Russia, 115478Local Institution - 0072 | Pyatigorsk , Russia, 357502Local Institution - 0075 | Saint Petersburg , Russia, 197758Local Institution - 0091 | Saint Petersburg , Russia, 198255Local Institution - 0073 | Sochi , Russia, 354057Local Institution - 0048 | Singapore , Singapore, 168583Local Institution - 0017 | Singapore , Singapore, 258499Local Institution - 0174 | Singapore , Singapore, 308442Local Institution - 0143 | Seongnam-si Gyeonggi-do, South Korea, 13496Local Institution - 0167 | Guro-gu Seoul, South Korea, 8308Local Institution - 0062 | Jongno-gu Seoul, South Korea, 03080Local Institution - 0142 | Busan , South Korea, 49241Local Institution - 0097 | Gyeonggi-do , South Korea, 010408Local Institution - 0098 | Gyeongsangnam-do , South Korea, 050612Local Institution - 0141 | Seoul , South Korea, 03722Local Institution - 0140 | Seoul , South Korea, 05505Local Institution - 0139 | Seoul , South Korea, 06351Local Institution - 0297 | Barcelona , Spain, 08035Local Institution - 0055 | Barcelona , Spain, 08036Local Institution - 0089 | Barcelona , Spain, 08908Local Institution - 0090 | Córdoba , Spain, 14004Local Institution - 0087 | El Palmar , Spain, 30120Local Institution - 0041 | Madrid , Spain, 28007Local Institution - 0093 | Madrid , Spain, 28028Local Institution - 0290 | Madrid , Spain, 28035Local Institution - 0045 | Majadahonda , Spain, 28222Local Institution - 0085 | Pamplona , Spain, 31008Local Institution - 0088 | Santander , Spain, 39008Local Institution - 0040 | Zaragoza , Spain, 50009Local Institution - 0063 | Bern , Switzerland, 3010Local Institution - 0272 | Kaohsiung City , Taiwan, 807Local Institution - 0096 | Kaohsiung City , Taiwan, 83301Local Institution - 0105 | Taichung , Taiwan, 40447Local Institution - 0271 | Taichung , Taiwan, 40705Local Institution - 0168 | Tainan , Taiwan, 704Local Institution - 0270 | Tainan , Taiwan, 736Local Institution - 0144 | Taipei , Taiwan, 10002Local Institution - 0078 | Taipei , Taiwan, 11266Local Institution - 0173 | Taoyuan , Taiwan, 333Local Institution - 0171 | London Greater London, United Kingdom, W12 OHSLocal Institution - 0154 | Guildford Surrey, United Kingdom, GU2 7XXLocal Institution - 0160 | Edinburgh , United Kingdom, EH4 2XULocal Institution - 0129 | London , United Kingdom, SE5 9RS
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb