A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (CheckMate 9DX)
A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Expanded Access
Expanded Access
Approved
- Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
- No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
- Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
- Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
Contacts and Locations
Study Locations
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Buenos Aires
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Gorriti, Buenos Aires, Argentina, 5737
- Local Institution - 0243
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Pilar, Buenos Aires, Argentina, 1629
- Local Institution - 0254
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Local Institution - 0244
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Local Institution - 0239
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Camperdown, New South Wales, Australia, 2050
- Local Institution - 0166
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Concord, New South Wales, Australia, 2139
- Local Institution - 0141
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Queensland
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Herston, Queensland, Australia, 4029
- Local Institution - 0220
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South Australia
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Adelaide, South Australia, Australia, 5000
- Local Institution - 0164
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Local Institution - 0224
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Local Institution - 0124
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Graz, Austria, 8036
- Local Institution - 0012
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Vienna, Austria, 1100
- Local Institution - 0001
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Vienna, Austria, 1090
- Local Institution - 0003
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Brussels, Belgium, 1070
- Local Institution - 0033
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Brussels, Belgium, 1200
- Local Institution - 0064
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Edegem, Belgium, 2650
- Local Institution - 0068
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Ghent, Belgium, 9000
- Local Institution - 0071
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Leuven, Belgium, 3000
- Local Institution - 0108
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São Paulo, Brazil, 01308-050
- Local Institution - 0023
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São Paulo, Brazil, 01509-010
- Local Institution - 0236
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30130-090
- Local Institution - 0090
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São Paulo
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Barretos, São Paulo, Brazil, 14780-070
- Local Institution - 0275
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Cerqueira César, São Paulo, Brazil, 01246-000
- Local Institution - 0237
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São José do Rio Preto, São Paulo, Brazil, 15090-000
- Local Institution
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São Paulo, São Paulo, Brazil, 08270-120
- Local Institution
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Edmonton, Canada, T6G 1Z2
- Local Institution - 0116
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- Local Institution
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Región de Valparaíso
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Viña del Mar, Región de Valparaíso, Chile, 2520598
- Local Institution - 0247
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile
- Local Institution - 0248
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Santiago, Santiago Metropolitan, Chile, 7710007
- Local Institution - 0246
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Santiago, Santiago Metropolitan, Chile, 8380420
- Local Institution - 0245
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Bogotá, Colombia
- Local Institution - 0256
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Bobigny, France, 93000
- Local Institution - 0057
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Brest, France, 29200
- Local Institution - 0052
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Clermont-Ferrand, France, 63003
- CHU Estaing
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Clichy, France, 92110
- Local Institution - 0046
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Créteil, France, 94010
- Local Institution - 0061
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Grenoble, France, 38043
- Local Institution - 0013
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Lille, France, 59037
- Local Institution - 0222
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Lyon, France, 69317
- Local Institution - 0051
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Montpellier, France, 34295
- Local Institution - 0043
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Nice, France, 06202
- Local Institution - 0037
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Poitiers, France, 86021
- Local Institution
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Reims, France, 51100
- Local Institution - 0098
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Rennes, France, 35033
- Local Institution - 0212
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Saint-Priest-en-Jarez, France, 42270
- Local Institution - 0044
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Vandœuvre-lès-Nancy, France, 54511
- Local Institution - 0011
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Villejuif, France, 94800
- Local Institution - 0054
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Aachen, Germany, 52057
- Local Institution - 0024
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Berlin, Germany, 13353
- Local Institution - 0258
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Bonn, Germany, 53127
- Local Institution - 0020
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Cologne, Germany, 50937
- Local Institution - 0050
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Essen, Germany, 45147
- Local Institution - 0026
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Frankfurt am Main, Germany, 60590
- Local Institution - 0093
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Hanover, Germany, 30625
- Local Institution - 0040
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Homburg, Germany, 66421
- Local Institution - 0019
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Leipzig, Germany, 04103
- Local Institution
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Magdeburg, Germany, 39104 Magdeburg
- Local Institution - 0036
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Mainz, Germany, 55131
- Local Institution - 0048
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Mannheim, Germany, 68167
- Universitätsmedizin Mannheim
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München, Germany, 81377
- Local Institution - 0096
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Tübingen, Germany, 72076
- Local Institution - 0008
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Würzburg, Germany, 97078
- Local Institution
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Hong Kong, Hong Kong, 999077
- Local Institution - 0120
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Hong Kong, Hong Kong
- Local Institution - 0076
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Bologna, Italy, 40138
- Local Institution - 0102
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Florence, Italy, 50134
- Local Institution - 0077
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Meldola, Italy, 47014
- Local Institution - 0104
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Milan, Italy, 20133
- Local Institution - 0091
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Modena, Italy, 41124
- Local Institution
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Monserrato, Italy, 09042
- Local Institution - 0134
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Napoli, Italy, 80131
- Local Institution - 0119
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Napoli, Italy, 80131
- Local Institution - 0101
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Padua, Italy, 35128
- Local Institution - 0103
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Rome, Italy, 00168
- Local Institution - 0125
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ME
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Messina, ME, Italy, 98125
- Local Institution - 0136
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Chiba, Japan, 260-8677
- Local Institution - 0187
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Hiroshima, Japan, 734-8551
- Local Institution - 0179
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Ishikawa, Japan, 920-8641
- Local Institution - 0180
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Kanagawa, Japan, 213-8587
- Local Institution - 0197
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Chiba
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Kashiwa-shi, Chiba, Japan, 2778577
- Local Institution - 0183
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Fukuoka
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Kurume-shi, Fukuoka, Japan, 8300011
- Local Institution - 0201
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Local Institution - 0200
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Sapporo, Hokkaido, Japan, 0600033
- Local Institution - 0184
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Hyōgo
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Nishinomiya-shi, Hyōgo, Japan, 6638501
- Local Institution - 0216
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Iwate
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Morioka, Iwate, Japan, 0208505
- Local Institution - 0257
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Kumamoto
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Kumamoto, Kumamoto, Japan, 8608556
- Local Institution - 0202
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Osaka
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Osaka, Osaka, Japan, 5438555
- Local Institution - 0203
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Osaka, Osaka, Japan, 5458586
- Local Institution - 0198
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Suita-shi, Osaka, Japan, 565-0871
- Local Institution - 0214
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Ōsaka-sayama, Osaka, Japan, 5898511
- Local Institution
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Tokushima
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Tokushima, Tokushima, Japan, 770-8503
- Local Institution - 0185
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 1138655
- Local Institution - 0215
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Chuo-ku, Tokyo, Japan, 1040045
- Local Institution - 0196
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Mitaka-shi, Tokyo, Japan, 181-8611
- Local Institution - 0182
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Musashino-shi, Tokyo, Japan, 1808610
- Local Institution - 0210
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Shinjuku-ku, Tokyo, Japan, 162-8655
- Local Institution - 0186
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San Luis Potosí City, Mexico, 78250
- Local Institution - 0226
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Durango
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Cuauhtémoc, Durango, Mexico, 06700
- Local Institution - 0148
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64000
- Local Institution - 0121
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Monterrey, Nuevo León, Mexico, 64460
- Local Institution - 0264
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Maastricht, Netherlands, 6229 HX
- Local Institution - 0263
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Utrecht, Netherlands, 3584CX
- Local Institution - 0260
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Auckland, New Zealand, 1023
- Local Institution - 0240
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San Juan, Puerto Rico, 00927
- Local Institution - 0231
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Brasov, Romania, 500091
- Local Institution
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Bucharest, Romania, 022328
- Local Institution - 0078
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Cluj-Napoca, Romania, 400015
- Local Institution - 0232
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Constanța, Romania, 900591
- Local Institution - 0242
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Craiova, Romania, 200542
- Local Institution - 0074
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Timișoara, Romania, 300166
- Local Institution - 0070
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Arkhangelsk, Russia, 163045
- Arkhangelsk Clinical Oncological Dispensary
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Leningrad Region, Russia, 188663
- Local Institution
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Moscow, Russia, 115478
- Local Institution - 0230
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Russia, 198255
- Local Institution - 0032
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Singapore, Singapore, 119228
- Local Institution - 0042
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Singapore, Singapore, 169610
- Local Institution - 0067
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Singapore, Singapore, 308433
- Local Institution - 0039
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Daegu, South Korea, 41944
- Local Institution - 0177
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Goyang-si, South Korea, 10408
- Local Institution - 0190
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Gyeongsangnam-do, South Korea, 50612
- Local Institution - 0188
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Jeollanam-do, South Korea, 58128
- Local Institution - 0178
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Seongnam-si, South Korea, 13620
- Local Institution - 0169
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Seoul, South Korea, 03080
- Local Institution - 0128
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Seoul, South Korea, 03722
- Local Institution - 0168
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Seoul, South Korea, 05505
- Local Institution - 0167
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Seoul, South Korea, 06591
- Local Institution - 0195
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Seoul, South Korea, 08308
- Local Institution - 0189
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Gyeonggi-do
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Suwon, Gyeonggi-do, South Korea, 16499
- Local Institution - 0191
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Seoul-teukbyeolsi [Seoul]
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Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
- Local Institution - 0127
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Barcelona, Spain, 08035
- Local Institution - 0069
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Barcelona, Spain, 08036
- Local Institution - 0031
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Córdoba, Spain, 14004
- Local Institution - 0016
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Donostia / San Sebastian, Spain, 20014
- Local Institution - 0072
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Madrid, Spain, 28007
- Local Institution - 0199
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Madrid, Spain, 28046
- Local Institution - 0109
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Pamplona, Spain, 31008
- Local Institution - 0100
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Sabadell (Barcelona), Spain, 08208
- Local Institution - 0010
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Seville, Spain, 41013
- Local Institution - 0028
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Valencia, Spain, 46026
- Local Institution - 0082
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Zaragoza, Spain, 50009
- Local Institution - 0097
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Kaohsiung City, Taiwan, 883
- Local Institution - 0204
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Taichung, Taiwan, 40447
- Local Institution - 0130
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Taichung, Taiwan, 40705
- Local Institution - 0140
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Tainan, Taiwan, 736
- Local Institution - 0174
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Taipei, Taiwan, 100
- Local Institution - 0207
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Taipei, Taiwan, 105
- Local Institution - 0173
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Taipei, Taiwan, 11217
- Local Institution - 0129
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Taoyuan District, Taiwan, 333
- Local Institution - 0175
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Yunlin, Taiwan, 632
- Local Institution - 0176
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TNN
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Tainan, TNN, Taiwan, 704
- Local Institution - 0131
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London, United Kingdom, NW3 2QG
- Local Institution - 0111
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London, United Kingdom, SE5 9RS
- Local Institution - 0092
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London, United Kingdom, W12 0HS
- Local Institution - 0153
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Manchester, United Kingdom, M20 4BX
- Local Institution - 0114
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Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
- Local Institution - 0142
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Alabama
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Anniston, Alabama, United States, 36207
- Local Institution - 0081
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Arizona
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Phoenix, Arizona, United States, 85054
- Mayo Clinic in Arizona - Phoenix
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Tucson, Arizona, United States, 85711
- Arizona Oncology Associates, PC - HOPE
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California
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Los Angeles, California, United States, 90095
- Local Institution - 0135
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Palo Alto, California, United States, 94304
- Local Institution - 0088
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San Francisco, California, United States, 94115
- Local Institution - 0085
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Colorado
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Aurora, Colorado, United States, 80045
- Local Institution - 0235
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Florida
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Miami, Florida, United States, 33136
- Sylvester Comprehensive Cancer Center/ UMHC
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Miami, Florida, United States, 33125
- Local Institution - 0267
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Tampa, Florida, United States, 33612
- Local Institution - 0163
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Georgia
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Atlanta, Georgia, United States, 30322
- Local Institution - 0009
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Kansas
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Westwood, Kansas, United States, 66205
- Local Institution - 0025
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Local Institution - 0086
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Minnesota Oncology Hematology, P.A.
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Missouri
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St Louis, Missouri, United States, 63110
- Local Institution - 0209
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New York
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New York, New York, United States, 10029
- Local Institution - 0208
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New York, New York, United States, 10016
- Local Institution - 0075
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New York, New York, United States, 10065
- Local Institution - 0045
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White Plains, New York, United States, 10601
- Local Institution - 0219
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Ohio
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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Oregon
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Portland, Oregon, United States, 97225
- Local Institution - 0206
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Texas
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Austin, Texas, United States, 78705
- Local Institution - 0272
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Dallas, Texas, United States, 75390
- Local Institution - 0156
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Dallas, Texas, United States, 75246
- Local Institution - 0270
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Tyler, Texas, United States, 75702
- Local Institution - 0273
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Virginia
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Richmond, Virginia, United States, 23249
- McGuire VA Medical Center
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Washington
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Seattle, Washington, United States, 98109
- Local Institution - 0154
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
- 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:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- 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]).
Other protocol defined inclusion/exclusion criteria apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Arm A
|
Specified dose on specified days
Other Names:
|
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Placebo Comparator: Arm B
|
specified dose on specified days
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Recurrence-free Survival (RFS)
Time Frame: Up to 49 months
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Up to 49 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival (OS)
Time Frame: Up to 7 years
|
Up to 7 years
|
|
Time to recurrence (TTR)
Time Frame: Up to 49 months
|
Up to 49 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Carcinoma
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Nivolumab
Other Study ID Numbers
Other Study ID Numbers
- CA209-9DX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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