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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free Survival (RFS) | Up to 49 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 7 years | |
| Time to recurrence (TTR) | Up to 49 months |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0081 | Anniston | Alabama | 36207 | United States | ||
| Mayo Clinic in Arizona - Phoenix |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Placebo | Other | specified dose on specified days |
|
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85711 | United States |
| Local Institution - 0135 | Los Angeles | California | 90095 | United States |
| Local Institution - 0088 | Palo Alto | California | 94304 | United States |
| Local Institution - 0085 | San Francisco | California | 94115 | United States |
| Local Institution - 0235 | Aurora | Colorado | 80045 | United States |
| Local Institution - 0267 | Miami | Florida | 33125 | United States |
| Sylvester Comprehensive Cancer Center/ UMHC | Miami | Florida | 33136 | United States |
| Local Institution - 0163 | Tampa | Florida | 33612 | United States |
| Local Institution - 0009 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 0025 | Westwood | Kansas | 66205 | United States |
| Local Institution - 0086 | New Orleans | Louisiana | 70112 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | United States |
| Local Institution - 0209 | St Louis | Missouri | 63110 | United States |
| Local Institution - 0075 | New York | New York | 10016 | United States |
| Local Institution - 0208 | New York | New York | 10029 | United States |
| Local Institution - 0045 | New York | New York | 10065 | United States |
| Local Institution - 0219 | White Plains | New York | 10601 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Local Institution - 0206 | Portland | Oregon | 97225 | United States |
| Local Institution - 0272 | Austin | Texas | 78705 | United States |
| Local Institution - 0270 | Dallas | Texas | 75246 | United States |
| Local Institution - 0156 | Dallas | Texas | 75390 | United States |
| Local Institution - 0273 | Tyler | Texas | 75702 | United States |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Local Institution - 0154 | Seattle | Washington | 98109 | United States |
| Local Institution - 0243 | Gorriti | Buenos Aires | 5737 | Argentina |
| Local Institution - 0254 | Pilar | Buenos Aires | 1629 | Argentina |
| Local Institution - 0244 | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution - 0239 | Blacktown | New South Wales | 2148 | Australia |
| Local Institution - 0166 | Camperdown | New South Wales | 2050 | Australia |
| Local Institution - 0141 | Concord | New South Wales | 2139 | Australia |
| Local Institution - 0220 | Herston | Queensland | 4029 | Australia |
| Local Institution - 0164 | Adelaide | South Australia | 5000 | Australia |
| Local Institution - 0224 | Heidelberg | Victoria | 3084 | Australia |
| Local Institution - 0124 | Nedlands | Western Australia | 6009 | Australia |
| Local Institution - 0012 | Graz | 8036 | Austria |
| Local Institution - 0003 | Vienna | 1090 | Austria |
| Local Institution - 0001 | Vienna | 1100 | Austria |
| Local Institution - 0033 | Brussels | 1070 | Belgium |
| Local Institution - 0064 | Brussels | 1200 | Belgium |
| Local Institution - 0068 | Edegem | 2650 | Belgium |
| Local Institution - 0071 | Ghent | 9000 | Belgium |
| Local Institution - 0108 | Leuven | 3000 | Belgium |
| Local Institution - 0090 | Belo Horizonte | Minas Gerais | 30130-090 | Brazil |
| Local Institution - 0275 | Barretos | São Paulo | 14780-070 | Brazil |
| Local Institution - 0237 | Cerqueira César | São Paulo | 01246-000 | Brazil |
| Local Institution | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Local Institution | São Paulo | São Paulo | 08270-120 | Brazil |
| Local Institution - 0023 | São Paulo | 01308-050 | Brazil |
| Local Institution - 0236 | São Paulo | 01509-010 | Brazil |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution - 0116 | Edmonton | T6G 1Z2 | Canada |
| Local Institution - 0248 | Santiago | Santiago Metropolitan | 0 | Chile |
| Local Institution - 0246 | Santiago | Santiago Metropolitan | 7710007 | Chile |
| Local Institution - 0245 | Santiago | Santiago Metropolitan | 8380420 | Chile |
| Local Institution - 0247 | Viña del Mar | Valparaiso | 2520598 | Chile |
| Local Institution - 0256 | Bogotá | 0 | Colombia |
| Local Institution - 0057 | Bobigny | 93000 | France |
| Local Institution - 0052 | Brest | 29200 | France |
| CHU Estaing | Clermont-Ferrand | 63003 | France |
| Local Institution - 0046 | Clichy | 92110 | France |
| Local Institution - 0061 | Créteil | 94010 | France |
| Local Institution - 0013 | Grenoble | 38043 | France |
| Local Institution - 0222 | Lille | 59037 | France |
| Local Institution - 0051 | Lyon | 69317 | France |
| Local Institution - 0043 | Montpellier | 34295 | France |
| Local Institution - 0037 | Nice | 06202 | France |
| Local Institution | Poitiers | 86021 | France |
| Local Institution - 0098 | Reims | 51100 | France |
| Local Institution - 0212 | Rennes | 35033 | France |
| Local Institution - 0044 | Saint-Priest-en-Jarez | 42270 | France |
| Local Institution - 0011 | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution - 0054 | Villejuif | 94800 | France |
| Local Institution - 0024 | Aachen | 52057 | Germany |
| Local Institution - 0258 | Berlin | 13353 | Germany |
| Local Institution - 0020 | Bonn | 53127 | Germany |
| Local Institution - 0050 | Cologne | 50937 | Germany |
| Local Institution - 0026 | Essen | 45147 | Germany |
| Local Institution - 0093 | Frankfurt am Main | 60590 | Germany |
| Local Institution - 0040 | Hanover | 30625 | Germany |
| Local Institution - 0019 | Homburg | 66421 | Germany |
| Local Institution | Leipzig | 04103 | Germany |
| Local Institution - 0036 | Magdeburg | 39104 Magdeburg | Germany |
| Local Institution - 0048 | Mainz | 55131 | Germany |
| Universitatsmedizin Mannheim | Mannheim | 68167 | Germany |
| Local Institution - 0096 | München | 81377 | Germany |
| Local Institution - 0008 | Tübingen | 72076 | Germany |
| Local Institution | Würzburg | 97078 | Germany |
| Local Institution - 0120 | Hong Kong | 999077 | Hong Kong |
| Local Institution - 0076 | Hong Kong | Hong Kong |
| Local Institution - 0136 | Messina | ME | 98125 | Italy |
| Local Institution - 0102 | Bologna | 40138 | Italy |
| Local Institution - 0077 | Florence | 50134 | Italy |
| Local Institution - 0104 | Meldola | 47014 | Italy |
| Local Institution - 0091 | Milan | 20133 | Italy |
| Local Institution | Modena | 41124 | Italy |
| Local Institution - 0134 | Monserrato | 09042 | Italy |
| Local Institution - 0101 | Naples | 80131 | Italy |
| Local Institution - 0119 | Naples | 80131 | Italy |
| Local Institution - 0103 | Padova | 35128 | Italy |
| Local Institution - 0125 | Rome | 00168 | Italy |
| Local Institution - 0183 | Kashiwa-shi | Chiba | 2778577 | Japan |
| Local Institution - 0201 | Kurume-shi | Fukuoka | 8300011 | Japan |
| Local Institution - 0200 | Sapporo | Hokkaido | 060-8648 | Japan |
| Local Institution - 0184 | Sapporo | Hokkaido | 0600033 | Japan |
| Local Institution - 0216 | Nishinomiya-shi | Hyōgo | 6638501 | Japan |
| Local Institution - 0257 | Morioka | Iwate | 0208505 | Japan |
| Local Institution - 0202 | Kumamoto | Kumamoto | 8608556 | Japan |
| Local Institution - 0203 | Osaka | Osaka | 5438555 | Japan |
| Local Institution - 0198 | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Ōsaka-sayama | Osaka | 5898511 | Japan |
| Local Institution - 0214 | Suita-shi | Osaka | 565-0871 | Japan |
| Local Institution - 0185 | Tokushima | Tokushima | 770-8503 | Japan |
| Local Institution - 0215 | Bunkyo-ku | Tokyo | 1138655 | Japan |
| Local Institution - 0196 | Chuo-ku | Tokyo | 1040045 | Japan |
| Local Institution - 0182 | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Local Institution - 0210 | Musashino-shi | Tokyo | 1808610 | Japan |
| Local Institution - 0186 | Shinjuku-ku | Tokyo | 162-8655 | Japan |
| Local Institution - 0187 | Chiba | 260-8677 | Japan |
| Local Institution - 0179 | Hiroshima | 734-8551 | Japan |
| Local Institution - 0180 | Ishikawa | 920-8641 | Japan |
| Local Institution - 0197 | Kanagawa | 213-8587 | Japan |
| Local Institution - 0148 | Cuauhtémoc | Durango | 06700 | Mexico |
| Local Institution - 0121 | Monterrey | Nuevo León | 64000 | Mexico |
| Local Institution - 0264 | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution - 0226 | San Luis Potosí City | 78250 | Mexico |
| Local Institution - 0263 | Maastricht | 6229 HX | Netherlands |
| Local Institution - 0260 | Utrecht | 3584CX | Netherlands |
| Local Institution - 0240 | Auckland | 1023 | New Zealand |
| Local Institution - 0231 | San Juan | 00927 | Puerto Rico |
| Local Institution | Brasov | 500091 | Romania |
| Local Institution - 0078 | Bucharest | 022328 | Romania |
| Local Institution - 0232 | Cluj-Napoca | 400015 | Romania |
| Local Institution - 0242 | Constanța | 900591 | Romania |
| Local Institution - 0074 | Craiova | 200542 | Romania |
| Local Institution - 0070 | Timișoara | 300166 | Romania |
| Local Institution - 0032 | Saint Petersburg | Sankt-Peterburg | 198255 | Russia |
| Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | 163045 | Russia |
| Local Institution | Leningrad Region | 188663 | Russia |
| Local Institution - 0230 | Moscow | 115478 | Russia |
| Local Institution - 0042 | Singapore | 119228 | Singapore |
| Local Institution - 0067 | Singapore | 169610 | Singapore |
| Local Institution - 0039 | Singapore | 308433 | Singapore |
| Local Institution - 0191 | Suwon | Gyeonggi-do | 16499 | South Korea |
| Local Institution - 0127 | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
| Local Institution - 0177 | Daegu | 41944 | South Korea |
| Local Institution - 0190 | Goyang-si | 10408 | South Korea |
| Local Institution - 0188 | Gyeongsangnam-do | 50612 | South Korea |
| Local Institution - 0178 | Jeollanam-do | 58128 | South Korea |
| Local Institution - 0169 | Seongnam-si | 13620 | South Korea |
| Local Institution - 0128 | Seoul | 03080 | South Korea |
| Local Institution - 0168 | Seoul | 03722 | South Korea |
| Local Institution - 0167 | Seoul | 05505 | South Korea |
| Local Institution - 0195 | Seoul | 06591 | South Korea |
| Local Institution - 0189 | Seoul | 08308 | South Korea |
| Local Institution - 0069 | Barcelona | 08035 | Spain |
| Local Institution - 0031 | Barcelona | 08036 | Spain |
| Local Institution - 0016 | Córdoba | 14004 | Spain |
| Local Institution - 0072 | Donostia / San Sebastian | 20014 | Spain |
| Local Institution - 0199 | Madrid | 28007 | Spain |
| Local Institution - 0109 | Madrid | 28046 | Spain |
| Local Institution - 0100 | Pamplona | 31008 | Spain |
| Local Institution - 0010 | Sabadell (Barcelona) | 08208 | Spain |
| Local Institution - 0028 | Seville | 41013 | Spain |
| Local Institution - 0082 | Valencia | 46026 | Spain |
| Local Institution - 0097 | Zaragoza | 50009 | Spain |
| Local Institution - 0131 | Tainan | TNN | 704 | Taiwan |
| Local Institution - 0204 | Kaohsiung City | 883 | Taiwan |
| Local Institution - 0130 | Taichung | 40447 | Taiwan |
| Local Institution - 0140 | Taichung | 40705 | Taiwan |
| Local Institution - 0174 | Tainan | 736 | Taiwan |
| Local Institution - 0207 | Taipei | 100 | Taiwan |
| Local Institution - 0173 | Taipei | 105 | Taiwan |
| Local Institution - 0129 | Taipei | 11217 | Taiwan |
| Local Institution - 0175 | Taoyuan | 333 | Taiwan |
| Local Institution - 0176 | Yunlin | 632 | Taiwan |
| Local Institution - 0111 | London | NW3 2QG | United Kingdom |
| Local Institution - 0092 | London | SE5 9RS | United Kingdom |
| Local Institution - 0153 | London | W12 0HS | United Kingdom |
| Local Institution - 0114 | Manchester | M20 4BX | United Kingdom |
| Local Institution - 0142 | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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