Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (184)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0243
Coordinator of this site? Confirm its status
GorritiArgentinaUnknown status
Local Institution - 0254
Coordinator of this site? Confirm its status
PilarArgentinaUnknown status
Local Institution - 0244
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Local Institution - 0012
Coordinator of this site? Confirm its status
GrazAustriaUnknown status
Local Institution - 0003
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
Local Institution - 0001
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
Local Institution - 0164
Coordinator of this site? Confirm its status
AdelaideAustraliaUnknown status
Local Institution - 0239
Coordinator of this site? Confirm its status
BlacktownAustraliaUnknown status
Local Institution - 0166
Coordinator of this site? Confirm its status
CamperdownAustraliaUnknown status
Local Institution - 0141
Coordinator of this site? Confirm its status
ConcordAustraliaUnknown status
Local Institution - 0224
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Local Institution - 0220
Coordinator of this site? Confirm its status
HerstonAustraliaUnknown status
Local Institution - 0124
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Local Institution - 0033
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Local Institution - 0064
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Local Institution - 0068
Coordinator of this site? Confirm its status
EdegemBelgiumUnknown status
Local Institution - 0071
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
Local Institution - 0108
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
Local Institution - 0275
Coordinator of this site? Confirm its status
BarretosBrazilUnknown status
Local Institution - 0090
Coordinator of this site? Confirm its status
Belo HorizonteBrazilUnknown status
Local Institution - 0237
Coordinator of this site? Confirm its status
Cerqueira CésarBrazilUnknown status
Local Institution
Coordinator of this site? Confirm its status
São José do Rio PretoBrazilUnknown status
Local Institution - 0236
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Local Institution - 0023
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Local Institution
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Local Institution
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Local Institution - 0116
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Local Institution - 0245
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0246
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0248
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0247
Coordinator of this site? Confirm its status
Viña del MarChileUnknown status
Local Institution - 0256
Coordinator of this site? Confirm its status
BogotáColombiaUnknown status
Local Institution - 0024
Coordinator of this site? Confirm its status
AachenGermanyUnknown status
Local Institution - 0258
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Local Institution - 0020
Coordinator of this site? Confirm its status
BonnGermanyUnknown status
Local Institution - 0050
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
Local Institution - 0026
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Local Institution - 0093
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyUnknown status
Local Institution - 0040
Coordinator of this site? Confirm its status
HanoverGermanyUnknown status
Local Institution - 0019
Coordinator of this site? Confirm its status
HomburgGermanyUnknown status
Local Institution
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Local Institution - 0036
Coordinator of this site? Confirm its status
MagdeburgGermanyUnknown status
Local Institution - 0048
Coordinator of this site? Confirm its status
MainzGermanyUnknown status
Universitätsmedizin Mannheim
Coordinator of this site? Confirm its status
MannheimGermanyUnknown status
Local Institution - 0096
Coordinator of this site? Confirm its status
MünchenGermanyUnknown status
Local Institution - 0008
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status
Local Institution
Coordinator of this site? Confirm its status
WürzburgGermanyUnknown status
Local Institution - 0031
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Local Institution - 0069
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Local Institution - 0016
Coordinator of this site? Confirm its status
CórdobaSpainUnknown status
Local Institution - 0072
Coordinator of this site? Confirm its status
Donostia / San SebastianSpainUnknown status
Local Institution - 0109
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0199
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0100
Coordinator of this site? Confirm its status
PamplonaSpainUnknown status
Local Institution - 0010
Coordinator of this site? Confirm its status
Sabadell (Barcelona)SpainUnknown status
Local Institution - 0028
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Local Institution - 0082
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Local Institution - 0097
Coordinator of this site? Confirm its status
ZaragozaSpainUnknown status
Local Institution - 0057
Coordinator of this site? Confirm its status
BobignyFranceUnknown status
Local Institution - 0052
Coordinator of this site? Confirm its status
BrestFranceUnknown status
CHU Estaing
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
Local Institution - 0046
Coordinator of this site? Confirm its status
ClichyFranceUnknown status
Local Institution - 0061
Coordinator of this site? Confirm its status
CréteilFranceUnknown status
Local Institution - 0013
Coordinator of this site? Confirm its status
GrenobleFranceUnknown status
Local Institution - 0222
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Local Institution - 0051
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Local Institution - 0043
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Local Institution - 0037
Coordinator of this site? Confirm its status
NiceFranceUnknown status
Local Institution
Coordinator of this site? Confirm its status
PoitiersFranceUnknown status
Local Institution - 0098
Coordinator of this site? Confirm its status
ReimsFranceUnknown status
Local Institution - 0212
Coordinator of this site? Confirm its status
RennesFranceUnknown status
Local Institution - 0044
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceUnknown status
Local Institution - 0011
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceUnknown status
Local Institution - 0054
Coordinator of this site? Confirm its status
VillejuifFranceUnknown status
Local Institution - 0153
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Local Institution - 0111
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Local Institution - 0092
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Local Institution - 0114
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Local Institution - 0142
Coordinator of this site? Confirm its status
Metropolitan Borough of WirralUnited KingdomUnknown status
Local Institution - 0120
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status
Local Institution - 0076
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status
Local Institution - 0102
Coordinator of this site? Confirm its status
BolognaItalyUnknown status
Local Institution - 0077
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status
Local Institution - 0104
Coordinator of this site? Confirm its status
MeldolaItalyUnknown status
Local Institution - 0136
Coordinator of this site? Confirm its status
MessinaItalyUnknown status
Local Institution - 0091
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Local Institution
Coordinator of this site? Confirm its status
ModenaItalyUnknown status
Local Institution - 0134
Coordinator of this site? Confirm its status
MonserratoItalyUnknown status
Local Institution - 0119
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
Local Institution - 0101
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
Local Institution - 0103
Coordinator of this site? Confirm its status
PadovaItalyUnknown status
Local Institution - 0125
Coordinator of this site? Confirm its status
RomeItalyUnknown status
Local Institution - 0215
Coordinator of this site? Confirm its status
Bunkyo-kuJapanUnknown status
Local Institution - 0187
Coordinator of this site? Confirm its status
ChibaJapanUnknown status
Local Institution - 0196
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Local Institution - 0179
Coordinator of this site? Confirm its status
HiroshimaJapanUnknown status
Local Institution - 0180
Coordinator of this site? Confirm its status
IshikawaJapanUnknown status
Local Institution - 0197
Coordinator of this site? Confirm its status
KanagawaJapanUnknown status
Local Institution - 0183
Coordinator of this site? Confirm its status
Kashiwa-shiJapanUnknown status
Local Institution - 0202
Coordinator of this site? Confirm its status
KumamotoJapanUnknown status
Local Institution - 0201
Coordinator of this site? Confirm its status
Kurume-shiJapanUnknown status
Local Institution - 0182
Coordinator of this site? Confirm its status
Mitaka-shiJapanUnknown status
Local Institution - 0257
Coordinator of this site? Confirm its status
MoriokaJapanUnknown status
Local Institution - 0210
Coordinator of this site? Confirm its status
Musashino-shiJapanUnknown status
Local Institution - 0216
Coordinator of this site? Confirm its status
Nishinomiya-shiJapanUnknown status
Local Institution - 0198
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Local Institution - 0203
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Local Institution
Coordinator of this site? Confirm its status
Ōsaka-sayamaJapanUnknown status
Local Institution - 0200
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Local Institution - 0184
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Local Institution - 0186
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Local Institution - 0214
Coordinator of this site? Confirm its status
Suita-shiJapanUnknown status
Local Institution - 0185
Coordinator of this site? Confirm its status
TokushimaJapanUnknown status
Local Institution - 0177
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
Local Institution - 0190
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaUnknown status
Local Institution - 0188
Coordinator of this site? Confirm its status
Gyeongsangnam-doSouth KoreaUnknown status
Local Institution - 0178
Coordinator of this site? Confirm its status
Jeollanam-doSouth KoreaUnknown status
Local Institution - 0169
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaUnknown status
Local Institution - 0128
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0127
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0195
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0168
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0189
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0167
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Local Institution - 0191
Coordinator of this site? Confirm its status
SuwonSouth KoreaUnknown status
Local Institution - 0148
Coordinator of this site? Confirm its status
CuauhtémocMexicoUnknown status
Local Institution - 0264
Coordinator of this site? Confirm its status
MonterreyMexicoUnknown status
Local Institution - 0121
Coordinator of this site? Confirm its status
MonterreyMexicoUnknown status
Local Institution - 0226
Coordinator of this site? Confirm its status
San Luis Potosí CityMexicoUnknown status
Local Institution - 0263
Coordinator of this site? Confirm its status
MaastrichtNetherlandsUnknown status
Local Institution - 0260
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status
Local Institution - 0240
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status
Local Institution - 0231
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
Local Institution
Coordinator of this site? Confirm its status
BrasovRomaniaUnknown status
Local Institution - 0078
Coordinator of this site? Confirm its status
BucharestRomaniaUnknown status
Local Institution - 0232
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaUnknown status
Local Institution - 0242
Coordinator of this site? Confirm its status
ConstanțaRomaniaUnknown status
Local Institution - 0074
Coordinator of this site? Confirm its status
CraiovaRomaniaUnknown status
Local Institution - 0070
Coordinator of this site? Confirm its status
TimișoaraRomaniaUnknown status
Arkhangelsk Clinical Oncological Dispensary
Coordinator of this site? Confirm its status
ArkhangelskRussiaUnknown status
Local Institution
Coordinator of this site? Confirm its status
Leningrad RegionRussiaUnknown status
Local Institution - 0230
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Local Institution - 0032
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Local Institution - 0039
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Local Institution - 0042
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Local Institution - 0067
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Local Institution - 0204
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
Local Institution - 0140
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Local Institution - 0130
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Local Institution - 0131
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
Local Institution - 0174
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
Local Institution - 0173
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Local Institution - 0207
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Local Institution - 0129
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Local Institution - 0175
Coordinator of this site? Confirm its status
TaoyuanTaiwanUnknown status
Local Institution - 0176
Coordinator of this site? Confirm its status
YunlinTaiwanUnknown status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Local Institution - 0081
Coordinator of this site? Confirm its status
AnnistonUnited StatesUnknown status
Local Institution - 0009
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Local Institution - 0235
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Local Institution - 0272
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
MetroHealth Medical Center
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Local Institution - 0156
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Local Institution - 0270
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Local Institution - 0135
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Sylvester Comprehensive Cancer Center/ UMHC
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Local Institution - 0267
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Minnesota Oncology Hematology, P.A.
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Local Institution - 0086
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Local Institution - 0208
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Local Institution - 0075
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Local Institution - 0045
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Local Institution - 0088
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status
Mayo Clinic in Arizona - Phoenix
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Local Institution - 0206
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
McGuire VA Medical Center
Coordinator of this site? Confirm its status
RichmondUnited StatesUnknown status
Local Institution - 0085
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Local Institution - 0154
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Local Institution - 0209
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Local Institution - 0163
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Arizona Oncology Associates, PC - HOPE
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status
Local Institution - 0273
Coordinator of this site? Confirm its status
TylerUnited StatesUnknown status
Local Institution - 0025
Coordinator of this site? Confirm its status
WestwoodUnited StatesUnknown status
Local Institution - 0219
Coordinator of this site? Confirm its status
White PlainsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.