Active, not recruitingNCT03383458CheckMate 9DXUpdated Jul 31, 2026

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 interventional study of Nivolumab and Placebo in Hepatocellular Carcinoma and Liver Cancer, sponsored by Bristol-Myers Squibb. Active, not recruiting at 184 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 545
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Hepatocellular Carcinoma
Liver Cancer

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 545 participants (actual)

Study arms

Experimental
Arm A
Biological: Nivolumab
Placebo comparator
Arm B
Other: Placebo

Interventions

BiologicalNivolumab
Specified dose on specified days
Also known as: Opdivo, BMS-936558
OtherPlacebo
specified dose on specified days

What researchers measure

Primary outcomes

Recurrence-free Survival (RFS)
Time frame: Up to 49 months

Secondary outcomes

Overall Survival (OS)
Time frame: Up to 7 years
Time to recurrence (TTR)
Time frame: Up to 49 months

Study locations

184 sites

Local Institution - 0081
Anniston, Alabama 36207, United States
Mayo Clinic in Arizona - Phoenix
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

Showing the first 100 of 184 sites across 25 countries.

References and documents

Individual participant data

Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Supporting information: Study protocol, Sap, Csr

Registry details

Key details

Study ID: NCT03383458
Lead sponsor: Bristol-Myers Squibb
Collaborators: Ono Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Dec 26, 2017
Start date: Apr 18, 2018
Primary completion: May 27, 2026
Completion: May 27, 2031 (estimated)
Last update: Jul 31, 2026

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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