A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
- Conditions
- Hepatocellular CarcinomaLiver Cancer
- Interventions
- Biological: NivolumabOther: Placebo
- Registration Number
- NCT03383458
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 545
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Nivolumab - Arm B Placebo -
- Primary Outcome Measures
Name Time Method Recurrence-free Survival (RFS) Up to 49 months
- Secondary Outcome Measures
Name Time Method Time to recurrence (TTR) Up to 49 months Overall Survival (OS) Up to 7 years
Trial Locations
- Locations (175)
Local Institution - 0009
🇺🇸Atlanta, Georgia, United States
Local Institution - 0220
🇦🇺Herston, Queensland, Australia
Local Institution - 0272
🇺🇸Austin, Texas, United States
Local Institution - 0153
🇬🇧London, United Kingdom
Local Institution - 0154
🇺🇸Seattle, Washington, United States
Local Institution - 0124
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0242
🇷🇴Constanta, Romania
Local Institution - 0067
🇸🇬Singapore, Singapore
Local Institution - 0076
🇭🇰Hong Kong, Hong Kong
Local Institution - 0254
🇦🇷Pilar, Buenos Aires, Argentina
Local Institution - 0243
🇦🇷Gorriti, Buenos Aires, Argentina
Local Institution - 0196
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0078
🇷🇴Bucharest, Romania
Local Institution - 0175
🇨🇳Taoyuan, Taiwan
Local Institution - 0210
🇯🇵Musashino-shi, Tokyo, Japan
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Local Institution - 0244
🇦🇷Rosario, Santa FE, Argentina
Local Institution - 0248
🇨🇱Santiago de Chile, Metropolitana, Chile
Local Institution - 0140
🇨🇳Taichung, Taiwan
Mayo Clinic in Arizona - Phoenix
🇺🇸Phoenix, Arizona, United States
Local Institution - 0103
🇮🇹Padova, Italy
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
Local Institution - 0025
🇺🇸Westwood, Kansas, United States
Miami VA Healthcare System
🇺🇸Miami, Florida, United States
Local Institution - 0081
🇺🇸Anniston, Alabama, United States
Local Institution - 0135
🇺🇸Los Angeles, California, United States
Sylvester Comprehensive Cancer Center/ UMHC
🇺🇸Miami, Florida, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Local Institution - 0001
🇦🇹Vienna, Austria
Local Institution - 0156
🇺🇸Dallas, Texas, United States
Local Institution - 0164
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0273
🇺🇸Tyler, Texas, United States
Local Institution - 0061
🇫🇷Creteil Cedex, France
Local Institution - 0208
🇺🇸New York, New York, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Local Institution - 0239
🇦🇺Blacktown, New South Wales, Australia
Local Institution - 0012
🇦🇹Graz, Austria
Local Institution - 0224
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0068
🇧🇪Edegem, Belgium
Local Institution - 0108
🇧🇪Leuven, Belgium
Local Institution - 0237
🇧🇷Cerqueira Cesar, SAO Paulo, Brazil
Local Institution - 0246
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0052
🇫🇷Brest, France
Local Institution - 0057
🇫🇷Bobigny, France
Local Institution - 0019
🇩🇪Homburg, Germany
Local Institution - 0036
🇩🇪Magdeburg, Germany
Local Institution - 0048
🇩🇪Mainz, Germany
Local Institution - 0222
🇫🇷Lille, France
Local Institution - 0051
🇫🇷Lyon Cedex 04, France
Local Institution - 0043
🇫🇷Montpellier Cedex, France
Local Institution - 0096
🇩🇪Muenchen, Germany
Local Institution - 0050
🇩🇪Koln, Germany
Local Institution - 0098
🇫🇷Reims, France
Local Institution - 0093
🇩🇪Frankfurt am Main, Germany
Local Institution - 0040
🇩🇪Hannover, Germany
Local Institution - 0037
🇫🇷Nice, France
Local Institution - 0008
🇩🇪Tuebingen, Germany
Local Institution - 0070
🇷🇴Timisoara, Romania
Local Institution - 0069
🇪🇸Barcelona, Spain
Local Institution - 0016
🇪🇸Córdoba, Spain
Local Institution - 0183
🇯🇵Kashiwa-shi, Chiba, Japan
Local Institution - 0189
🇰🇷Seoul, Korea, Republic of
Local Institution - 0186
🇯🇵Shinjuku-ku, Tokyo, Japan
Local Institution - 0109
🇪🇸Madrid, Spain
Fondazione Policlinico Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Local Institution - 0200
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0177
🇰🇷Daegu, Korea, Republic of
Local Institution - 0201
🇯🇵Kurume-shi, Fukuoka, Japan
Local Institution - 0128
🇰🇷Seoul, Korea, Republic of
Local Institution - 0215
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0191
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Local Institution - 0127
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0185
🇯🇵Tokushima-shi, Tokushima, Japan
Local Institution - 0188
🇰🇷Gyeongsangnam-do, Korea, Republic of
Local Institution - 0231
🇵🇷San Juan, Puerto Rico
Local Institution - 0264
🇲🇽Monterrey, Nuevo Leon, Mexico
Local Institution - 0121
🇲🇽Monterrey, Nuevo León, Mexico
Local Institution - 0260
🇳🇱Utrecht, Netherlands
Local Institution - 0226
🇲🇽San Luis Potosi, Mexico
Local Institution - 0240
🇳🇿Auckland, New Zealand
Local Institution - 0148
🇲🇽Cuauhtemoc, Durango, Mexico
Local Institution - 0263
🇳🇱Maastricht, Netherlands
Local Institution - 0042
🇸🇬Singapore, Singapore
Local Institution - 0031
🇪🇸Barcelona, Spain
Local Institution - 0176
🇨🇳Yunlin, Taiwan
Local Institution - 0100
🇪🇸Pamplona, Spain
Local Institution - 0028
🇪🇸Sevilla, Spain
Local Institution - 0102
🇮🇹Bologna, Italy
Local Institution - 0091
🇮🇹Milano, Italy
Local Institution - 0134
🇮🇹Monserrato, Italy
Local Institution - 0119
🇮🇹Napoli, Italy
Local Institution - 0077
🇮🇹Firenze, Italy
Local Institution - 0104
🇮🇹Meldola, Italy
Azienda Ospedaliera Specialistica dei Colli Monaldi-Cotugno-CTO
🇮🇹Napoli, Italy
Local Institution - 0023
🇧🇷Sao Paulo, Brazil
Local Institution - 0184
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0216
🇯🇵Nishinomiya-shi, Hyogo, Japan
Local Institution - 0202
🇯🇵Kumamoto-shi, Kumamoto, Japan
Local Institution - 0257
🇯🇵Morioka-shi, Iwate, Japan
Local Institution - 0179
🇯🇵Hiroshima, Japan
Local Institution - 0197
🇯🇵Kanagawa, Japan
CHU Estaing
🇫🇷Clermont Ferrand, France
Local Institution - 0212
🇫🇷Rennes Cedex 9, France
Local Institution - 0044
🇫🇷Saint-Priest-en-Jarez, France
Local Institution - 0011
🇫🇷Vandoeuvre Les Nancy Cedex, France
Universitatsmedizin Mannheim
🇩🇪Mannheim, Germany
Local Institution - 0097
🇪🇸Zaragoza, Spain
Local Institution - 0166
🇦🇺Camperdown, New South Wales, Australia
Local Institution - 0219
🇺🇸White Plains, New York, United States
Local Institution - 0141
🇦🇺Concord, New South Wales, Australia
Local Institution - 0275
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0054
🇫🇷Villejuif, France
Local Institution - 0088
🇺🇸Palo Alto, California, United States
Local Institution - 0085
🇺🇸San Francisco, California, United States
Local Institution - 0075
🇺🇸New York, New York, United States
Local Institution - 0209
🇺🇸Saint Louis, Missouri, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0206
🇺🇸Portland, Oregon, United States
Texas Oncology Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Local Institution - 0235
🇺🇸Aurora, Colorado, United States
Local Institution - 0163
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Local Institution - 0033
🇧🇪Brussels, Belgium
Local Institution - 0003
🇦🇹Wien, Austria
Local Institution - 0071
🇧🇪Gent, Belgium
Local Institution
🇷🇺Leningrad Region, Russian Federation
Local Institution - 0090
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0236
🇧🇷Sao Paulo, Brazil
Local Institution - 0116
🇨🇦Edmonton, Canada
Local Institution - 0245
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0247
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0256
🇨🇴Bogota, Colombia
Local Institution - 0046
🇫🇷Clichy, France
Local Institution - 0232
🇷🇴Cluj-Napoca, Romania
Local Institution - 0013
🇫🇷Grenoble Cedex 09, France
Local Institution - 0074
🇷🇴Craiova, Romania
Local Institution - 0020
🇩🇪Bonn, Germany
Local Institution - 0026
🇩🇪Essen, Germany
Local Institution - 0024
🇩🇪Aachen, Germany
Local Institution - 0258
🇩🇪Berlin, Germany
Local Institution - 0136
🇮🇹Messina, ME, Italy
Local Institution - 0187
🇯🇵Chiba-shi, Chiba, Japan
Local Institution - 0180
🇯🇵Kanazawa-shi, Ishikawa, Japan
Local Institution - 0203
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0198
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0214
🇯🇵Suita-shi, Osaka, Japan
Local Institution - 0182
🇯🇵Mitaka-shi, Tokyo, Japan
Local Institution - 0190
🇰🇷Goyang-si, Korea, Republic of
Local Institution - 0178
🇰🇷Jeollanam-do, Korea, Republic of
Local Institution - 0129
🇨🇳Taipei, Taiwan
Local Institution - 0169
🇰🇷Seongnam-si, Korea, Republic of
Local Institution - 0168
🇰🇷Seoul, Korea, Republic of
Local Institution - 0167
🇰🇷Seoul, Korea, Republic of
Local Institution - 0195
🇰🇷Seoul, Korea, Republic of
Local Institution - 0032
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
Arkhangelsk Clinical Oncological Dispensary
🇷🇺Arkhangelsk, Russian Federation
Local Institution - 0230
🇷🇺Moscow, Russian Federation
Local Institution - 0039
🇸🇬Singapore, Singapore
Local Institution - 0072
🇪🇸Donostia-San Sebastian, Spain
Local Institution - 0199
🇪🇸Madrid, Spain
Local Institution - 0010
🇪🇸Sabadell (Barcelona), Spain
Local Institution - 0131
🇨🇳Tainan, TNN, Taiwan
Local Institution - 0082
🇪🇸Valencia, Spain
Local Institution - 0204
🇨🇳Kaohsiung, Taiwan
Local Institution - 0130
🇨🇳Taichung, Taiwan
Local Institution - 0174
🇨🇳Tainan, Taiwan
Local Institution - 0207
🇨🇳Taipei, Taiwan
Local Institution - 0173
🇨🇳Taipei, Taiwan
Local Institution - 0111
🇬🇧London, United Kingdom
Local Institution - 0114
🇬🇧Manchester, United Kingdom
Local Institution - 0092
🇬🇧London, United Kingdom
Local Institution - 0142
🇬🇧Wirral, United Kingdom
Local Institution - 0064
🇧🇪Bruxelles, Belgium
Local Institution - 0086
🇺🇸New Orleans, Louisiana, United States
Local Institution - 0120
🇭🇰Hong Kong, Hong Kong