A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
NCT ID: NCT03383458
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
545 participants
INTERVENTIONAL
2018-04-18
2031-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Nivolumab
Specified dose on specified days
Arm B
Placebo
specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Placebo
specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
* Child-Pugh Score 5 or 6
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria
* Any evidence of tumor metastasis or co-existing malignant disease
* Participants previously receiving any prior therapy for HCC, including loco-regional therapies
* Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
* Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]).
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0081
Anniston, Alabama, United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Local Institution - 0135
Los Angeles, California, United States
Local Institution - 0088
Palo Alto, California, United States
Local Institution - 0085
San Francisco, California, United States
Local Institution - 0235
Aurora, Colorado, United States
Local Institution - 0267
Miami, Florida, United States
Sylvester Comprehensive Cancer Center/ UMHC
Miami, Florida, United States
Local Institution - 0163
Tampa, Florida, United States
Local Institution - 0009
Atlanta, Georgia, United States
Local Institution - 0025
Westwood, Kansas, United States
Local Institution - 0086
New Orleans, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Local Institution - 0209
St Louis, Missouri, United States
Local Institution - 0075
New York, New York, United States
Local Institution - 0208
New York, New York, United States
Local Institution - 0045
New York, New York, United States
Local Institution - 0219
White Plains, New York, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Local Institution - 0206
Portland, Oregon, United States
Local Institution - 0272
Austin, Texas, United States
Local Institution - 0270
Dallas, Texas, United States
Local Institution - 0156
Dallas, Texas, United States
Local Institution - 0273
Tyler, Texas, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Local Institution - 0154
Seattle, Washington, United States
Local Institution - 0243
Gorriti, Buenos Aires, Argentina
Local Institution - 0254
Pilar, Buenos Aires, Argentina
Local Institution - 0244
Rosario, Santa Fe Province, Argentina
Local Institution - 0239
Blacktown, New South Wales, Australia
Local Institution - 0166
Camperdown, New South Wales, Australia
Local Institution - 0141
Concord, New South Wales, Australia
Local Institution - 0220
Herston, Queensland, Australia
Local Institution - 0164
Adelaide, South Australia, Australia
Local Institution - 0224
Heidelberg, Victoria, Australia
Local Institution - 0124
Nedlands, Western Australia, Australia
Local Institution - 0012
Graz, , Austria
Local Institution - 0003
Vienna, , Austria
Local Institution - 0001
Vienna, , Austria
Local Institution - 0033
Brussels, , Belgium
Local Institution - 0064
Brussels, , Belgium
Local Institution - 0068
Edegem, , Belgium
Local Institution - 0071
Ghent, , Belgium
Local Institution - 0108
Leuven, , Belgium
Local Institution - 0090
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0275
Barretos, São Paulo, Brazil
Local Institution - 0237
Cerqueira César, São Paulo, Brazil
Local Institution
São José do Rio Preto, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution - 0023
São Paulo, , Brazil
Local Institution - 0236
São Paulo, , Brazil
Local Institution
Calgary, Alberta, Canada
Local Institution - 0116
Edmonton, , Canada
Local Institution - 0247
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0248
Santiago, Santiago Metropolitan, Chile
Local Institution - 0246
Santiago, Santiago Metropolitan, Chile
Local Institution - 0245
Santiago, Santiago Metropolitan, Chile
Local Institution - 0256
Bogotá, , Colombia
Local Institution - 0057
Bobigny, , France
Local Institution - 0052
Brest, , France
CHU Estaing
Clermont-Ferrand, , France
Local Institution - 0046
Clichy, , France
Local Institution - 0061
Créteil, , France
Local Institution - 0013
Grenoble, , France
Local Institution - 0222
Lille, , France
Local Institution - 0051
Lyon, , France
Local Institution - 0043
Montpellier, , France
Local Institution - 0037
Nice, , France
Local Institution
Poitiers, , France
Local Institution - 0098
Reims, , France
Local Institution - 0212
Rennes, , France
Local Institution - 0044
Saint-Priest-en-Jarez, , France
Local Institution - 0011
Vandœuvre-lès-Nancy, , France
Local Institution - 0054
Villejuif, , France
Local Institution - 0024
Aachen, , Germany
Local Institution - 0258
Berlin, , Germany
Local Institution - 0020
Bonn, , Germany
Local Institution - 0050
Cologne, , Germany
Local Institution - 0026
Essen, , Germany
Local Institution - 0093
Frankfurt am Main, , Germany
Local Institution - 0040
Hanover, , Germany
Local Institution - 0019
Homburg, , Germany
Local Institution
Leipzig, , Germany
Local Institution - 0036
Magdeburg, , Germany
Local Institution - 0048
Mainz, , Germany
Universitatsmedizin Mannheim
Mannheim, , Germany
Local Institution - 0096
München, , Germany
Local Institution - 0008
Tübingen, , Germany
Local Institution
Würzburg, , Germany
Local Institution - 0120
Hong Kong, , Hong Kong
Local Institution - 0076
Hong Kong, , Hong Kong
Local Institution - 0136
Messina, ME, Italy
Local Institution - 0102
Bologna, , Italy
Local Institution - 0077
Florence, , Italy
Local Institution - 0104
Meldola, , Italy
Local Institution - 0091
Milan, , Italy
Local Institution
Modena, , Italy
Local Institution - 0134
Monserrato, , Italy
Local Institution - 0101
Napoli, , Italy
Local Institution - 0119
Napoli, , Italy
Local Institution - 0103
Padua, , Italy
Local Institution - 0125
Rome, , Italy
Local Institution - 0183
Kashiwa-shi, Chiba, Japan
Local Institution - 0201
Kurume-shi, Fukuoka, Japan
Local Institution - 0200
Sapporo, Hokkaido, Japan
Local Institution - 0184
Sapporo, Hokkaido, Japan
Local Institution - 0216
Nishinomiya-shi, Hyōgo, Japan
Local Institution - 0257
Morioka, Iwate, Japan
Local Institution - 0202
Kumamoto, Kumamoto, Japan
Local Institution - 0203
Osaka, Osaka, Japan
Local Institution - 0198
Osaka, Osaka, Japan
Local Institution
Ōsaka-sayama, Osaka, Japan
Local Institution - 0214
Suita-shi, Osaka, Japan
Local Institution - 0185
Tokushima, Tokushima, Japan
Local Institution - 0215
Bunkyo-ku, Tokyo, Japan
Local Institution - 0196
Chuo-ku, Tokyo, Japan
Local Institution - 0182
Mitaka-shi, Tokyo, Japan
Local Institution - 0210
Musashino-shi, Tokyo, Japan
Local Institution - 0186
Shinjuku-ku, Tokyo, Japan
Local Institution - 0187
Chiba, , Japan
Local Institution - 0179
Hiroshima, , Japan
Local Institution - 0180
Ishikawa, , Japan
Local Institution - 0197
Kanagawa, , Japan
Local Institution - 0148
Cuauhtémoc, Durango, Mexico
Local Institution - 0121
Monterrey, Nuevo León, Mexico
Local Institution - 0264
Monterrey, Nuevo León, Mexico
Local Institution - 0226
San Luis Potosí City, , Mexico
Local Institution - 0263
Maastricht, , Netherlands
Local Institution - 0260
Utrecht, , Netherlands
Local Institution - 0240
Auckland, , New Zealand
Local Institution - 0231
San Juan, , Puerto Rico
Local Institution
Brasov, , Romania
Local Institution - 0078
Bucharest, , Romania
Local Institution - 0232
Cluj-Napoca, , Romania
Local Institution - 0242
Constanța, , Romania
Local Institution - 0074
Craiova, , Romania
Local Institution - 0070
Timișoara, , Romania
Local Institution - 0032
Saint Petersburg, Sankt-Peterburg, Russia
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, , Russia
Local Institution
Leningrad Region, , Russia
Local Institution - 0230
Moscow, , Russia
Local Institution - 0042
Singapore, , Singapore
Local Institution - 0067
Singapore, , Singapore
Local Institution - 0039
Singapore, , Singapore
Local Institution - 0191
Suwon, Gyeonggi-do, South Korea
Local Institution - 0127
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0177
Daegu, , South Korea
Local Institution - 0190
Goyang-si, , South Korea
Local Institution - 0188
Gyeongsangnam-do, , South Korea
Local Institution - 0178
Jeollanam-do, , South Korea
Local Institution - 0169
Seongnam-si, , South Korea
Local Institution - 0128
Seoul, , South Korea
Local Institution - 0168
Seoul, , South Korea
Local Institution - 0167
Seoul, , South Korea
Local Institution - 0195
Seoul, , South Korea
Local Institution - 0189
Seoul, , South Korea
Local Institution - 0069
Barcelona, , Spain
Local Institution - 0031
Barcelona, , Spain
Local Institution - 0016
Córdoba, , Spain
Local Institution - 0072
Donostia / San Sebastian, , Spain
Local Institution - 0199
Madrid, , Spain
Local Institution - 0109
Madrid, , Spain
Local Institution - 0100
Pamplona, , Spain
Local Institution - 0010
Sabadell (Barcelona), , Spain
Local Institution - 0028
Seville, , Spain
Local Institution - 0082
Valencia, , Spain
Local Institution - 0097
Zaragoza, , Spain
Local Institution - 0131
Tainan, TNN, Taiwan
Local Institution - 0204
Kaohsiung City, , Taiwan
Local Institution - 0130
Taichung, , Taiwan
Local Institution - 0140
Taichung, , Taiwan
Local Institution - 0174
Tainan, , Taiwan
Local Institution - 0207
Taipei, , Taiwan
Local Institution - 0173
Taipei, , Taiwan
Local Institution - 0129
Taipei, , Taiwan
Local Institution - 0175
Taoyuan District, , Taiwan
Local Institution - 0176
Yunlin, , Taiwan
Local Institution - 0111
London, , United Kingdom
Local Institution - 0092
London, , United Kingdom
Local Institution - 0153
London, , United Kingdom
Local Institution - 0114
Manchester, , United Kingdom
Local Institution - 0142
Metropolitan Borough of Wirral, , United Kingdom
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA209-9DX
Identifier Type: -
Identifier Source: org_study_id
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