NCT03383458Active, not recruitingPhase 3
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 545 (actual)
- First submitted
- 21 Dec 2017
- Start date
- 18 Apr 2018
- Primary completion date
- 27 May 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT03383458
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 545
- From 18 Apr 2018 to the primary completion date, 27 May 2026
- 184 sites in 25 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any evidence of tumor metastasis or co-existing malignant disease
Other
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (184)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0243 Coordinator of this site? Confirm its status | Gorriti | Argentina | Unknown status |
| Local Institution - 0254 Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| Local Institution - 0244 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Local Institution - 0164 Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Local Institution - 0239 Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Local Institution - 0166 Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Local Institution - 0141 Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| Local Institution - 0224 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Local Institution - 0220 Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Local Institution - 0124 Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Local Institution - 0064 Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Local Institution - 0068 Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| Local Institution - 0071 Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Local Institution - 0108 Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Local Institution - 0275 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Local Institution - 0090 Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Local Institution - 0237 Coordinator of this site? Confirm its status | Cerqueira César | Brazil | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Local Institution - 0236 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution - 0023 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Local Institution - 0116 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Local Institution - 0245 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0246 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0248 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Local Institution - 0247 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Local Institution - 0256 Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Local Institution - 0258 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Local Institution - 0036 Coordinator of this site? Confirm its status | Magdeburg | Germany | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Universitätsmedizin Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Local Institution - 0096 Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Local Institution - 0072 Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| Local Institution - 0109 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0199 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Local Institution - 0100 Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Sabadell (Barcelona) | Spain | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Local Institution - 0082 Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Local Institution - 0097 Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Local Institution - 0057 Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Local Institution - 0046 Coordinator of this site? Confirm its status | Clichy | France | Unknown status |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Local Institution - 0013 Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Local Institution - 0222 Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Local Institution - 0051 Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Local Institution - 0043 Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Local Institution - 0098 Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Local Institution - 0212 Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Local Institution - 0153 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0111 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0092 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Local Institution - 0142 Coordinator of this site? Confirm its status | Metropolitan Borough of Wirral | United Kingdom | Unknown status |
| Local Institution - 0120 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Local Institution - 0102 Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Local Institution - 0104 Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Local Institution - 0136 Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Monserrato | Italy | Unknown status |
| Local Institution - 0119 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Local Institution - 0101 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Local Institution - 0103 Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Local Institution - 0125 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Local Institution - 0215 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Local Institution - 0187 Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Local Institution - 0196 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 0179 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 0180 Coordinator of this site? Confirm its status | Ishikawa | Japan | Unknown status |
| Local Institution - 0197 Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Local Institution - 0183 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Local Institution - 0202 Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Local Institution - 0201 Coordinator of this site? Confirm its status | Kurume-shi | Japan | Unknown status |
| Local Institution - 0182 Coordinator of this site? Confirm its status | Mitaka-shi | Japan | Unknown status |
| Local Institution - 0257 Coordinator of this site? Confirm its status | Morioka | Japan | Unknown status |
| Local Institution - 0210 Coordinator of this site? Confirm its status | Musashino-shi | Japan | Unknown status |
| Local Institution - 0216 Coordinator of this site? Confirm its status | Nishinomiya-shi | Japan | Unknown status |
| Local Institution - 0198 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Local Institution - 0203 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Ōsaka-sayama | Japan | Unknown status |
| Local Institution - 0200 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0184 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Institution - 0186 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Local Institution - 0214 Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Local Institution - 0185 Coordinator of this site? Confirm its status | Tokushima | Japan | Unknown status |
| Local Institution - 0177 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Local Institution - 0190 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Local Institution - 0188 Coordinator of this site? Confirm its status | Gyeongsangnam-do | South Korea | Unknown status |
| Local Institution - 0178 Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| Local Institution - 0169 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Local Institution - 0128 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0127 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0195 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0168 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0189 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0167 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Local Institution - 0191 Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Local Institution - 0148 Coordinator of this site? Confirm its status | Cuauhtémoc | Mexico | Unknown status |
| Local Institution - 0264 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Local Institution - 0121 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Local Institution - 0226 Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Local Institution - 0263 Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Local Institution - 0260 Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Local Institution - 0240 Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Local Institution - 0231 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Brasov | Romania | Unknown status |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Local Institution - 0232 Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Local Institution - 0242 Coordinator of this site? Confirm its status | Constanța | Romania | Unknown status |
| Local Institution - 0074 Coordinator of this site? Confirm its status | Craiova | Romania | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
| Arkhangelsk Clinical Oncological Dispensary Coordinator of this site? Confirm its status | Arkhangelsk | Russia | Unknown status |
| Local Institution Coordinator of this site? Confirm its status | Leningrad Region | Russia | Unknown status |
| Local Institution - 0230 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Local Institution - 0039 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0042 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0067 Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Local Institution - 0204 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Local Institution - 0140 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0130 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Local Institution - 0131 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0174 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Local Institution - 0173 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0207 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0129 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Local Institution - 0175 Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Local Institution - 0176 Coordinator of this site? Confirm its status | Yunlin | Taiwan | Unknown status |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Local Institution - 0081 Coordinator of this site? Confirm its status | Anniston | United States | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Local Institution - 0235 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Local Institution - 0272 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| MetroHealth Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Local Institution - 0156 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0270 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 0135 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Sylvester Comprehensive Cancer Center/ UMHC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Local Institution - 0267 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Minnesota Oncology Hematology, P.A. Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Local Institution - 0086 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Local Institution - 0208 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0075 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0045 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 0088 Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Mayo Clinic in Arizona - Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Local Institution - 0206 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| McGuire VA Medical Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Local Institution - 0085 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Local Institution - 0154 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Local Institution - 0209 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Local Institution - 0163 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Arizona Oncology Associates, PC - HOPE Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Local Institution - 0273 Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
| Local Institution - 0219 Coordinator of this site? Confirm its status | White Plains | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.