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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 545 (actual) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | Nivolumab, Placebo |
| Locations | 184 sites (Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia and more) |
| Trial ID | NCT03383458 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
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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
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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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.