A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (CheckMate 9DX)

November 18, 2025 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

545

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Gorriti, Buenos Aires, Argentina, 5737
        • Local Institution - 0243
      • Pilar, Buenos Aires, Argentina, 1629
        • Local Institution - 0254
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Local Institution - 0244
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution - 0239
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution - 0166
      • Concord, New South Wales, Australia, 2139
        • Local Institution - 0141
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Local Institution - 0220
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0164
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0224
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0124
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0012
      • Vienna, Austria, 1100
        • Local Institution - 0001
      • Vienna, Austria, 1090
        • Local Institution - 0003
  • Belgium
      • Brussels, Belgium, 1070
        • Local Institution - 0033
      • Brussels, Belgium, 1200
        • Local Institution - 0064
      • Edegem, Belgium, 2650
        • Local Institution - 0068
      • Ghent, Belgium, 9000
        • Local Institution - 0071
      • Leuven, Belgium, 3000
        • Local Institution - 0108
  • Brazil
      • São Paulo, Brazil, 01308-050
        • Local Institution - 0023
      • São Paulo, Brazil, 01509-010
        • Local Institution - 0236
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Local Institution - 0090
    • São Paulo
      • Barretos, São Paulo, Brazil, 14780-070
        • Local Institution - 0275
      • Cerqueira César, São Paulo, Brazil, 01246-000
        • Local Institution - 0237
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Local Institution
      • São Paulo, São Paulo, Brazil, 08270-120
        • Local Institution
  • Canada
      • Edmonton, Canada, T6G 1Z2
        • Local Institution - 0116
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
  • Chile
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • Local Institution - 0247
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0248
      • Santiago, Santiago Metropolitan, Chile, 7710007
        • Local Institution - 0246
      • Santiago, Santiago Metropolitan, Chile, 8380420
        • Local Institution - 0245
  • Colombia
      • Bogotá, Colombia
        • Local Institution - 0256
  • France
      • Bobigny, France, 93000
        • Local Institution - 0057
      • Brest, France, 29200
        • Local Institution - 0052
      • Clermont-Ferrand, France, 63003
        • CHU Estaing
      • Clichy, France, 92110
        • Local Institution - 0046
      • Créteil, France, 94010
        • Local Institution - 0061
      • Grenoble, France, 38043
        • Local Institution - 0013
      • Lille, France, 59037
        • Local Institution - 0222
      • Lyon, France, 69317
        • Local Institution - 0051
      • Montpellier, France, 34295
        • Local Institution - 0043
      • Nice, France, 06202
        • Local Institution - 0037
      • Poitiers, France, 86021
        • Local Institution
      • Reims, France, 51100
        • Local Institution - 0098
      • Rennes, France, 35033
        • Local Institution - 0212
      • Saint-Priest-en-Jarez, France, 42270
        • Local Institution - 0044
      • Vandœuvre-lès-Nancy, France, 54511
        • Local Institution - 0011
      • Villejuif, France, 94800
        • Local Institution - 0054
  • Germany
      • Aachen, Germany, 52057
        • Local Institution - 0024
      • Berlin, Germany, 13353
        • Local Institution - 0258
      • Bonn, Germany, 53127
        • Local Institution - 0020
      • Cologne, Germany, 50937
        • Local Institution - 0050
      • Essen, Germany, 45147
        • Local Institution - 0026
      • Frankfurt am Main, Germany, 60590
        • Local Institution - 0093
      • Hanover, Germany, 30625
        • Local Institution - 0040
      • Homburg, Germany, 66421
        • Local Institution - 0019
      • Leipzig, Germany, 04103
        • Local Institution
      • Magdeburg, Germany, 39104 Magdeburg
        • Local Institution - 0036
      • Mainz, Germany, 55131
        • Local Institution - 0048
      • Mannheim, Germany, 68167
        • Universitätsmedizin Mannheim
      • München, Germany, 81377
        • Local Institution - 0096
      • Tübingen, Germany, 72076
        • Local Institution - 0008
      • Würzburg, Germany, 97078
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Local Institution - 0120
      • Hong Kong, Hong Kong
        • Local Institution - 0076
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 0102
      • Florence, Italy, 50134
        • Local Institution - 0077
      • Meldola, Italy, 47014
        • Local Institution - 0104
      • Milan, Italy, 20133
        • Local Institution - 0091
      • Modena, Italy, 41124
        • Local Institution
      • Monserrato, Italy, 09042
        • Local Institution - 0134
      • Napoli, Italy, 80131
        • Local Institution - 0119
      • Napoli, Italy, 80131
        • Local Institution - 0101
      • Padua, Italy, 35128
        • Local Institution - 0103
      • Rome, Italy, 00168
        • Local Institution - 0125
    • ME
      • Messina, ME, Italy, 98125
        • Local Institution - 0136
  • Japan
      • Chiba, Japan, 260-8677
        • Local Institution - 0187
      • Hiroshima, Japan, 734-8551
        • Local Institution - 0179
      • Ishikawa, Japan, 920-8641
        • Local Institution - 0180
      • Kanagawa, Japan, 213-8587
        • Local Institution - 0197
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0183
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 8300011
        • Local Institution - 0201
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Local Institution - 0200
      • Sapporo, Hokkaido, Japan, 0600033
        • Local Institution - 0184
    • Hyōgo
      • Nishinomiya-shi, Hyōgo, Japan, 6638501
        • Local Institution - 0216
    • Iwate
      • Morioka, Iwate, Japan, 0208505
        • Local Institution - 0257
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 8608556
        • Local Institution - 0202
    • Osaka
      • Osaka, Osaka, Japan, 5438555
        • Local Institution - 0203
      • Osaka, Osaka, Japan, 5458586
        • Local Institution - 0198
      • Suita-shi, Osaka, Japan, 565-0871
        • Local Institution - 0214
      • Ōsaka-sayama, Osaka, Japan, 5898511
        • Local Institution
    • Tokushima
      • Tokushima, Tokushima, Japan, 770-8503
        • Local Institution - 0185
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138655
        • Local Institution - 0215
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0196
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Local Institution - 0182
      • Musashino-shi, Tokyo, Japan, 1808610
        • Local Institution - 0210
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Local Institution - 0186
  • Mexico
      • San Luis Potosí City, Mexico, 78250
        • Local Institution - 0226
    • Durango
      • Cuauhtémoc, Durango, Mexico, 06700
        • Local Institution - 0148
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Local Institution - 0121
      • Monterrey, Nuevo León, Mexico, 64460
        • Local Institution - 0264
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Local Institution - 0263
      • Utrecht, Netherlands, 3584CX
        • Local Institution - 0260
  • New Zealand
      • Auckland, New Zealand, 1023
        • Local Institution - 0240
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution - 0231
  • Romania
      • Brasov, Romania, 500091
        • Local Institution
      • Bucharest, Romania, 022328
        • Local Institution - 0078
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0232
      • Constanța, Romania, 900591
        • Local Institution - 0242
      • Craiova, Romania, 200542
        • Local Institution - 0074
      • Timișoara, Romania, 300166
        • Local Institution - 0070
  • Russia
      • Arkhangelsk, Russia, 163045
        • Arkhangelsk Clinical Oncological Dispensary
      • Leningrad Region, Russia, 188663
        • Local Institution
      • Moscow, Russia, 115478
        • Local Institution - 0230
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 198255
        • Local Institution - 0032
  • Singapore
      • Singapore, Singapore, 119228
        • Local Institution - 0042
      • Singapore, Singapore, 169610
        • Local Institution - 0067
      • Singapore, Singapore, 308433
        • Local Institution - 0039
  • South Korea
      • Daegu, South Korea, 41944
        • Local Institution - 0177
      • Goyang-si, South Korea, 10408
        • Local Institution - 0190
      • Gyeongsangnam-do, South Korea, 50612
        • Local Institution - 0188
      • Jeollanam-do, South Korea, 58128
        • Local Institution - 0178
      • Seongnam-si, South Korea, 13620
        • Local Institution - 0169
      • Seoul, South Korea, 03080
        • Local Institution - 0128
      • Seoul, South Korea, 03722
        • Local Institution - 0168
      • Seoul, South Korea, 05505
        • Local Institution - 0167
      • Seoul, South Korea, 06591
        • Local Institution - 0195
      • Seoul, South Korea, 08308
        • Local Institution - 0189
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Local Institution - 0191
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Local Institution - 0127
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0069
      • Barcelona, Spain, 08036
        • Local Institution - 0031
      • Córdoba, Spain, 14004
        • Local Institution - 0016
      • Donostia / San Sebastian, Spain, 20014
        • Local Institution - 0072
      • Madrid, Spain, 28007
        • Local Institution - 0199
      • Madrid, Spain, 28046
        • Local Institution - 0109
      • Pamplona, Spain, 31008
        • Local Institution - 0100
      • Sabadell (Barcelona), Spain, 08208
        • Local Institution - 0010
      • Seville, Spain, 41013
        • Local Institution - 0028
      • Valencia, Spain, 46026
        • Local Institution - 0082
      • Zaragoza, Spain, 50009
        • Local Institution - 0097
  • Taiwan
      • Kaohsiung City, Taiwan, 883
        • Local Institution - 0204
      • Taichung, Taiwan, 40447
        • Local Institution - 0130
      • Taichung, Taiwan, 40705
        • Local Institution - 0140
      • Tainan, Taiwan, 736
        • Local Institution - 0174
      • Taipei, Taiwan, 100
        • Local Institution - 0207
      • Taipei, Taiwan, 105
        • Local Institution - 0173
      • Taipei, Taiwan, 11217
        • Local Institution - 0129
      • Taoyuan District, Taiwan, 333
        • Local Institution - 0175
      • Yunlin, Taiwan, 632
        • Local Institution - 0176
    • TNN
      • Tainan, TNN, Taiwan, 704
        • Local Institution - 0131
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Local Institution - 0111
      • London, United Kingdom, SE5 9RS
        • Local Institution - 0092
      • London, United Kingdom, W12 0HS
        • Local Institution - 0153
      • Manchester, United Kingdom, M20 4BX
        • Local Institution - 0114
      • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
        • Local Institution - 0142
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Local Institution - 0081
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona - Phoenix
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates, PC - HOPE
    • California
      • Los Angeles, California, United States, 90095
        • Local Institution - 0135
      • Palo Alto, California, United States, 94304
        • Local Institution - 0088
      • San Francisco, California, United States, 94115
        • Local Institution - 0085
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0235
    • Florida
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center/ UMHC
      • Miami, Florida, United States, 33125
        • Local Institution - 0267
      • Tampa, Florida, United States, 33612
        • Local Institution - 0163
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0009
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Local Institution - 0025
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Local Institution - 0086
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0209
    • New York
      • New York, New York, United States, 10029
        • Local Institution - 0208
      • New York, New York, United States, 10016
        • Local Institution - 0075
      • New York, New York, United States, 10065
        • Local Institution - 0045
      • White Plains, New York, United States, 10601
        • Local Institution - 0219
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
    • Oregon
      • Portland, Oregon, United States, 97225
        • Local Institution - 0206
    • Texas
      • Austin, Texas, United States, 78705
        • Local Institution - 0272
      • Dallas, Texas, United States, 75390
        • Local Institution - 0156
      • Dallas, Texas, United States, 75246
        • Local Institution - 0270
      • Tyler, Texas, United States, 75702
        • Local Institution - 0273
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Placebo Comparator: Arm B
Other: Placebo
specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free Survival (RFS)
Time Frame: Up to 49 months
Up to 49 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 7 years
Up to 7 years
Time to recurrence (TTR)
Time Frame: Up to 49 months
Up to 49 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2018

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

February 27, 2031

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Estimated)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-9DX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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