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A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Sponsor: Bristol-Myers Squibb
Summary
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
545
Start Date
2018-04-18
Completion Date
2031-02-27
Last Updated
2025-11-21
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
Specified dose on specified days
Placebo
specified dose on specified days
Locations (184)
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
Naples, Italy
Local Institution - 0119
Naples, Italy
Local Institution - 0103
Padova, 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