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

ClinicalTrials.gov processed this data on May 1, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified May 2024 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 30, 2019
First Posted: July 31, 2019
Last Update Posted: May 2, 2024
Last Verified: May 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Hepatocellular Carcinoma
  • Drug: Nivolumab
  • Drug: Ipilimumab
  • Drug: Sorafenib
  • Drug: lenvatinib

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 30, 2019
Anticipated Primary Completion DateSeptember 30, 2026
Anticipated Study Completion DateSeptember 30, 2026

Groups and Cohorts

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

        Outcome Measures

        Primary Outcome Measures

        1. Overall Survival (OS) [Up to 4 years]

        Secondary Outcome Measures

        1. Objective Response Rate (ORR) [Up to 4 years]
        2. Duration of Response (DOR) [Up to 4 years]
        3. Time to Symptom Deterioration (TTSD) [Up to 4 years]

        Eligibility Criteria

        Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
        Sexes Eligible for Study All
        Accepts Healthy Volunteers No
        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 Collaborators Bristol-Myers Squibb
        Locations
        • Local Institution - 0292 | Tucson, Arizona, United States, 85719
        • Local Institution - 0288 | Coronado, California, United States, 92118
        • Local Institution - 0157 | Duarte, California, United States, 91010-3012
        • Local Institution - 0077 | Washington, District of Columbia, United States, 20007
        • Local Institution - 0027 | Louisville, Kentucky, United States, 40217
        • Local Institution - 0190 | Baltimore, Maryland, United States, 21287
        • Local Institution | Ann Arbor, Michigan, United States, 48105
        • Local Institution - 0018 | Detroit, Michigan, United States, 48202
        • Local Institution - 0295 | Newark, New Jersey, United States, 07103
        • Local Institution - 0043 | Toledo, Ohio, United States, 43623
        • Local Institution - 0284 | Pittsburgh, Pennsylvania, United States, 15212
        • Local Institution - 0304 | Dallas, Texas, United States, 75203
        • Local Institution - 0202 | Houston, Texas, United States, 77030
        • Local Institution - 0046 | Lubbock, Texas, United States, 79410
        • Local Institution - 0172 | Salt Lake City, Utah, United States, 84106
        • Local Institution - 0037 | Caba, Buenos Aires, Argentina, C1090AAS
        • Local Institution - 0194 | Pilar Provincia De Buenos Aires, Buenos Aires, Argentina, B1629ODT
        • Local Institution - 0282 | Rosario, Santa Fe, Argentina, 2000
        • Local Institution - 0136 | Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0058 | Tucuman, Argentina, 4000
        • Local Institution - 0003 | Kogarah, New South Wales, Australia, 2217
        • Local Institution - 0038 | Liverpool, New South Wales, Australia, 1871
        • Local Institution - 0002 | Westmead, New South Wales, Australia, 2145
        • Local Institution - 0004 | Birtinya, Queensland, Australia, 4560
        • Local Institution - 0013 | Herston, Queensland, Australia, 4029
        • Local Institution - 0009 | Adelaide, South Australia, Australia, 5000
        • Local Institution - 0019 | Clayton, Victoria, Australia, 3168
        • Local Institution - 0026 | Fitzroy, Victoria, Australia, 3065
        • Local Institution - 0001 | Melbourne, Victoria, Australia, 3004
        • Local Institution - 0020 | St Albans, Victoria, Australia, 3021
        • Local Institution - 0114 | St. Polten, Niederosterreich, Austria, 3100
        • Local Institution - 0057 | Wiener Neustadt, Niederosterreich, Austria, 2700
        • Local Institution - 0188 | Graz, Austria, 8036
        • Local Institution - 0065 | Klagenfurt, Austria, 9020
        • Local Institution - 0186 | Viena, Austria, 1090
        • Local Institution - 0034 | Brussels, Belgium, 1070
        • Local Institution - 0008 | Federal District, Belgium, 72115700
        • Local Institution - 0124 | Gent, Belgium, 9000
        • Local Institution - 0298 | Gent, Belgium, 9000
        • Local Institution - 0099 | Haine-Saint-Paul, Belgium, 7100
        • Local Institution - 0064 | Leuven, Belgium, 3000
        • Local Institution - 0104 | Liege, Belgium, 4000
        • Local Institution | Salvador, Bahia, Brazil, 41253190
        • Local Institution - 0061 | Salvador, Bahia, Brazil, 41950-640
        • Local Institution - 0181 | Brasilia, DF, Brazil, 70200-730
        • Local Institution - 0278 | Vitoria, Espirito Santo, Brazil, 29055-450
        • Local Institution - 0279 | Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • Local Institution - 0060 | Pelotas, RIO Grande DO SUL, Brazil, 96020-360
        • Local Institution - 0054 | Jau, SAO Paulo, Brazil, 17210-120
        • Local Institution - 0280 | Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Local Institution - 0016 | Parana, Brazil, 81520-060
        • Local Institution - 0015 | Rio de Janeiro, Brazil, 22793-080
        • Local Institution - 0023 | Sao Paulo, Brazil, 01246-000
        • Local Institution - 0022 | Sao Paulo, Brazil, 01323-900
        • Local Institution - 0050 | Sao Paulo, Brazil, 04038-034
        • Local Institution - 0192 | Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0296 | Temuco, Araucania, Chile, 4780000
        • Local Institution - 0094 | La Serena, Coquimbo, Chile, 1720430
        • Local Institution - 0095 | Santiago de Chile, Metropolitana, Chile, Array
        • Local Institution - 0024 | Santiago, Metropolitana, Chile, 7620002
        • Local Institution - 0156 | Santiago, Metropolitana, Chile, 8380456
        • Local Institution - 0283 | Santiago, RM, Chile, 7630372
        • Local Institution - 0012 | Vina del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0216 | Vina del Mar, Valparaiso, Chile, 2540402
        • Local Institution - 0120 | Hefei Shi, Anhui, China, 230022
        • Local Institution - 0146 | Hefei, Anhui, China, 230065
        • Local Institution - 0175 | Beijing, Beijing, China, 100000
        • Local Institution - 0152 | Beijing, Beijing, China, 100853
        • Local Institution - 0121 | Fuzhou City, Fujian, China, 350014
        • Local Institution - 0151 | Fuzhou, Fujian, China, 350002
        • Local Institution - 0125 | Guangzhou, Guangdong, China, 510000
        • Local Institution - 0150 | Guangzhou, Guangdong, China, 510515
        • Local Institution - 0135 | Harbin, Heilongjiang, China, 150081
        • Local Institution - 0109 | Changsha, Hunan, China, 410006
        • Local Institution - 0059 | Changsha, Hunan, China, 410011
        • Local Institution - 0130 | Nanjing, Jiangsu, China, 210002
        • Local Institution - 0145 | Nanchang, Jiangxi, China, 330006
        • Local Institution - 0149 | Nanchang, Jiangxi, China, 330019
        • Local Institution - 0162 | Changchun, Jilin, China, 130021
        • Local Institution - 0166 | Changchun, Jilin, China, 130102
        • Local Institution - 0131 | Dalian, Liaoning, China, 116023
        • Local Institution - 0123 | Shenyang, Liaoning, China, 110004
        • Local Institution - 0132 | Shenyang, Liaoning, China, 110117
        • Local Institution - 0307 | Xi'an, Shan3xi, China, 710100
        • Local Institution - 0133 | Xian, Shan3xi, China, 710038
        • Local Institution - 0147 | Xian, Shan3xi, China, 710061
        • Local Institution - 0153 | Qingdao, Shandong, China, 266000
        • Local Institution - 0134 | Shanghai, Shanghai, China, 200032
        • Local Institution - 0179 | Chongqing, Sichuan, China, 400030
        • Local Institution - 0108 | Hangzhou, Zhejiang, China, 310000
        • Local Institution - 0107 | Hangzhou, Zhejiang, China, 310022
        • Local Institution - 0274 | Praha, Prague, Czechia, 14059
        • Local Institution | Brno, Czechia, 60200
        • Local Institution - 0068 | Amiens, France, 80054
        • Local Institution - 0116 | Caen, France, 14033
        • Local Institution - 0069 | Clichy, France, 92110
        • Local Institution - 0138 | Dijon, France, 21000
        • Local Institution - 0081 | Grenoble Cedex 9, France, 38043
        • Local Institution - 0070 | Lyon, France, 69004
        • Local Institution | Marseille, France, 13009
        • Local Institution - 0082 | Montpellier, France, 34295
        • Local Institution - 0067 | Nice, France, 6202
        • Local Institution - 0025 | Pessac, France, 33604
        • Local Institution - 0137 | Poitiers, France, 86021
        • Local Institution - 0042 | Toulouse Cedex 9, France, 31059
        • Local Institution - 0071 | Vandoeuvre les Nancy, France, 54500
        • Local Institution - 0051 | Villejuif, France, 94800
        • Local Institution - 0005 | Frankfurt, Hessen, Germany, 60590
        • Local Institution - 0231 | Bonn, Germany, 53127
        • Local Institution - 0052 | Essen, Germany, 45147
        • Local Institution - 0185 | Freiburg, Germany, 79106
        • Local Institution - 0006 | Hamburg, Germany, 20246
        • Local Institution - 0102 | Hannover, Germany, 30625
        • Local Institution - 0028 | Koeln, Germany, 50937
        • Local Institution - 0118 | Leipzig, Germany, 04103
        • Local Institution - 0031 | Mainz, Germany, 55131
        • Local Institution - 0056 | Mannheim, Germany, 68167
        • Local Institution | Munchen, Germany, 81675
        • Local Institution - 0053 | North Rhine-Westphalia, Germany, 45136
        • Local Institution - 0036 | Hong Kong, Hong Kong, 999077
        • Local Institution - 0032 | Hong Kong, Hong Kong,
        • Local Institution - 0110 | Meldola, Forli-Cesena, Italy, 47014
        • Local Institution - 0101 | Rozzano, Milano, Italy, 20089
        • Local Institution - 0084 | Candiolo, Italy, 10060
        • Local Institution - 0039 | Milano, Italy, 20122
        • Local Institution - 0100 | Novara, Italy, 28100
        • Local Institution - 0219 | Padova, Italy, 35128
        • Local Institution - 0033 | Parma, Italy, 43126
        • Local Institution - 0112 | Roma, Italy, 00128
        • Local Institution - 0079 | Rome, Italy, 00168
        • Local Institution - 0111 | Siena, Italy, 53100
        • Local Institution - 0044 | Vicenza, Italy, 36100
        • Local Institution - 0193 | Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0203 | Matsuyama, Ehime, Japan, 790-0024
        • Local Institution - 0176 | Kanazawa, Ishikawa, Japan, 920-8641
        • Local Institution - 0200 | Yokohama-Shi, Kanagawa, Japan, 232-0024
        • Local Institution - 0262 | Yokohama-shi, Kanagawa, Japan, 241-8515
        • Local Institution - 0189 | Kyoto-shi, Kyoto, Japan, 602-8566
        • Local Institution - 0261 | Kashihara City, Nara, Japan, 634-8522
        • Local Institution - 0263 | Abeno-ku, Osaka, Japan, 5458586
        • Local Institution - 0127 | Osakasayama, Osaka, Japan, 5898511
        • Local Institution - 0281 | Saga Shi, Saga, Japan, 8408571
        • Local Institution - 0258 | Iruma-gun, Saitama, Japan, 3500495
        • Local Institution - 0259 | Izunokuni-shi, Shizuoka, Japan, 410-2295
        • Local Institution - 0122 | Minato-ku, Tokyo, Japan, 105-8470
        • Local Institution - 0128 | Minato, Tokyo, Japan, 105-8470
        • Local Institution - 0201 | Mitaka, Tokyo, Japan, 181-8611
        • Local Institution - 0199 | Musashino-shi, Tokyo, Japan, 180-8610
        • Local Institution - 0204 | Chiba, Japan, 260-8677
        • Local Institution - 0178 | Fukuoka, Japan, 830-0011
        • Local Institution - 0177 | Hiroshima, Japan, 7348551
        • Local Institution - 0155 | Sapporo, Japan, 0600033
        • Local Institution - 0143 | Seongnam, Gyeonggi-do, Korea, Republic of, 13496
        • Local Institution - 0167 | Guro-gu, Seoul, Korea, Republic of, 8308
        • Local Institution - 0062 | Jongno-gu, Seoul, Korea, Republic of, 03080
        • Local Institution - 0142 | Busan, Korea, Republic of, 49241
        • Local Institution - 0097 | Gyeonggi-do, Korea, Republic of, 010408
        • Local Institution - 0098 | Gyeongsangnam-do, Korea, Republic of, 050612
        • Local Institution - 0141 | Seoul, Korea, Republic of, 03722
        • Local Institution - 0140 | Seoul, Korea, Republic of, 05505
        • Local Institution - 0139 | Seoul, Korea, Republic of, 06351
        • Local Institution - 0286 | Christchurch, Canterbury, New Zealand, 8011
        • Local Institution - 0047 | Auckland, New Zealand, 1023
        • Local Institution - 0148 | Gdansk, Poland, 80219
        • Local Institution - 0049 | Otwock, Poland, 05-400
        • Local Institution - 0092 | Warszawa, Poland, 02-034
        • Local Institution - 0289 | Rio Piedras, Puerto Rico, 00935
        • Local Institution - 0035 | San Juan, Puerto Rico, 00927-4308
        • Local Institution - 0103 | Craiova, Dolj, Romania, 200542
        • Local Institution - 0164 | Bucharest, Romania, 022328
        • Local Institution - 0165 | Cluj Napoca, Romania, 400015
        • Local Institution | Craiova, Romania, 200385
        • Local Institution - 0163 | Timisoara, Romania, 300166
        • Local Institution - 0029 | Arkhangelsk, Russian Federation, 163045
        • Local Institution - 0066 | Barnaul, Russian Federation, 656045
        • Local Institution - 0074 | Chelyabinsk, Russian Federation, 454087
        • Local Institution - 0007 | Moscow, Russian Federation, 115478
        • Local Institution - 0072 | Pyatigorsk, Russian Federation, 357502
        • Local Institution - 0075 | Saint-Petersburg, Russian Federation, 197758
        • Local Institution - 0091 | Saint-Petersburg, Russian Federation, 198255
        • Local Institution - 0073 | Sochi, Russian Federation, 354057
        • Local Institution - 0048 | Singapore, Singapore, 168583
        • Local Institution - 0017 | Singapore, Singapore, 258499
        • Local Institution - 0174 | Singapore, Singapore, 308442
        • Local Institution - 0297 | Barcelona, Spain, 08035
        • Local Institution - 0055 | Barcelona, Spain, 08036
        • Local Institution - 0089 | Barcelona, Spain, 08908
        • Local Institution - 0090 | Cordoba, Spain, 14004
        • Local Institution - 0087 | El Palmar, Spain, 30120
        • Local Institution - 0041 | Madrid, Spain, 28007
        • Local Institution - 0093 | Madrid, Spain, 28028
        • Local Institution - 0290 | Madrid, Spain, 28035
        • Local Institution - 0045 | Majadahonda, Spain, 28222
        • Local Institution - 0085 | Pamplona, Spain, 31008
        • Local Institution - 0088 | Santander, Spain, 39008
        • Local Institution - 0040 | Zaragoza, Spain, 50009
        • Local Institution - 0063 | Bern, Switzerland, 3010
        • Local Institution - 0272 | Kaohsiung, Taiwan, 807
        • Local Institution - 0096 | Kaohsiung, Taiwan, 83301
        • Local Institution - 0105 | Taichung, Taiwan, 40447
        • Local Institution - 0271 | Taichung, Taiwan, 40705
        • Local Institution - 0168 | Tainan, Taiwan, 704
        • Local Institution - 0270 | Tainan, Taiwan, 736
        • Local Institution - 0144 | Taipei, Taiwan, 10002
        • Local Institution - 0078 | Taipei, Taiwan, 11266
        • Local Institution - 0173 | Taoyuan, Taiwan, 333
        • Local Institution - 0171 | London, Greater London, United Kingdom, W12 OHS
        • Local Institution - 0154 | Guildford, Surrey, United Kingdom, GU2 7XX
        • Local Institution - 0160 | Edinburgh, United Kingdom, EH4 2XU
        • Local Institution - 0129 | London, United Kingdom, SE5 9RS
        Investigators

          More Information

          Additional Information

          Additional Relevant MeSH Terms

          • Carcinoma
          • Carcinoma, Hepatocellular
          • Neoplasms, Glandular and Epithelial
          • Neoplasms by Histologic Type
          • Neoplasms
          • Adenocarcinoma
          • Liver Neoplasms
          • Digestive System Neoplasms
          • Neoplasms by Site
          • Digestive System Diseases
          • Liver Diseases