Clinical trial Phase 3 Interventional Ages 18 and up

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Run by Bristol-Myers Squibb · NCT03383458 · Data updated 2026-11-12

Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2026-05-27.

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

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment545 (actual)
SponsorBristol-Myers Squibb
Industry-sponsored
Drugs / interventionsNivolumab, Placebo
Locations184 sites (Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia and more)
Trial IDNCT03383458 on ClinicalTrials.gov

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

  • 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
Show 44 more locations
  • 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

+134 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Bristol-Myers Squibb — Bristol-Myers Squibb

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.