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Hepatocellular CarcinomaPhase 3CheckMate 9DXNCT03383458

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 study testing Nivolumab in people with Hepatocellular Carcinoma and Liver Cancer, run by Bristol-Myers Squibb at 184 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma, Liver Cancer
What is being tested?
Nivolumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
545 participants
Where
184 sitesin 25 countries
Study dates
18 Apr 2018to 27 May 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

184 sites in 25 countries.

184 sites in 25 countries

United States28 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Local Institution - 0081

    Anniston, Alabama, 36207

  • Local Institution - 0009

    Atlanta, Georgia, 30322

  • Local Institution - 0235

    Aurora, Colorado, 80045

  • Local Institution - 0272

    Austin, Texas, 78705

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Local Institution - 0270

    Dallas, Texas, 75246

  • Local Institution - 0156

    Dallas, Texas, 75390

  • Local Institution - 0135

    Los Angeles, California, 90095

  • Local Institution - 0267

    Miami, Florida, 33125

  • Sylvester Comprehensive Cancer Center/ UMHC

    Miami, Florida, 33136

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Local Institution - 0086

    New Orleans, Louisiana, 70112

  • Local Institution - 0075

    New York, New York, 10016

  • Local Institution - 0208

    New York, New York, 10029

  • Local Institution - 0045

    New York, New York, 10065

  • Local Institution - 0088

    Palo Alto, California, 94304

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona, 85054

  • Local Institution - 0206

    Portland, Oregon, 97225

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Local Institution - 0085

    San Francisco, California, 94115

  • Local Institution - 0154

    Seattle, Washington, 98109

  • Local Institution - 0209

    St Louis, Missouri, 63110

  • Local Institution - 0163

    Tampa, Florida, 33612

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • Local Institution - 0273

    Tyler, Texas, 75702

  • Local Institution - 0025

    Westwood, Kansas, 66205

  • Local Institution - 0219

    White Plains, New York, 10601

Other trials in United States

Japan21 sites

  • Local Institution - 0215

    Bunkyo-ku, Tokyo, 1138655

  • Local Institution - 0187

    Chiba, 260-8677

  • Local Institution - 0196

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 0179

    Hiroshima, 734-8551

  • Local Institution - 0180

    Ishikawa, 920-8641

  • Local Institution - 0197

    Kanagawa, 213-8587

  • Local Institution - 0183

    Kashiwa-shi, Chiba, 2778577

  • Local Institution - 0202

    Kumamoto, Kumamoto, 8608556

  • Local Institution - 0201

    Kurume-shi, Fukuoka, 8300011

  • Local Institution - 0182

    Mitaka-shi, Tokyo, 181-8611

  • Local Institution - 0257

    Morioka, Iwate, 0208505

  • Local Institution - 0210

    Musashino-shi, Tokyo, 1808610

  • Local Institution - 0216

    Nishinomiya-shi, Hyōgo, 6638501

  • Local Institution - 0203

    Osaka, Osaka, 5438555

  • Local Institution - 0198

    Osaka, Osaka, 5458586

  • Local Institution

    Ōsaka-sayama, Osaka, 5898511

  • Local Institution - 0200

    Sapporo, Hokkaido, 060-8648

  • Local Institution - 0184

    Sapporo, Hokkaido, 0600033

  • Local Institution - 0186

    Shinjuku-ku, Tokyo, 162-8655

  • Local Institution - 0214

    Suita-shi, Osaka, 565-0871

  • Local Institution - 0185

    Tokushima, Tokushima, 770-8503

Other trials in Japan

France16 sites

  • Local Institution - 0057

    Bobigny, 93000

  • Local Institution - 0052

    Brest, 29200

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Local Institution - 0046

    Clichy, 92110

  • Local Institution - 0061

    Créteil, 94010

  • Local Institution - 0013

    Grenoble, 38043

  • Local Institution - 0222

    Lille, 59037

  • Local Institution - 0051

    Lyon, 69317

  • Local Institution - 0043

    Montpellier, 34295

  • Local Institution - 0037

    Nice, 06202

  • Local Institution

    Poitiers, 86021

  • Local Institution - 0098

    Reims, 51100

  • Local Institution - 0212

    Rennes, 35033

  • Local Institution - 0044

    Saint-Priest-en-Jarez, 42270

  • Local Institution - 0011

    Vandœuvre-lès-Nancy, 54511

  • Local Institution - 0054

    Villejuif, 94800

Other trials in France

Germany15 sites

  • Local Institution - 0024

    Aachen, 52057

  • Local Institution - 0258

    Berlin, 13353

  • Local Institution - 0020

    Bonn, 53127

  • Local Institution - 0050

    Cologne, 50937

  • Local Institution - 0026

    Essen, 45147

  • Local Institution - 0093

    Frankfurt am Main, 60590

  • Local Institution - 0040

    Hanover, 30625

  • Local Institution - 0019

    Homburg, 66421

  • Local Institution

    Leipzig, 04103

  • Local Institution - 0036

    Magdeburg, 39104 Magdeburg

  • Local Institution - 0048

    Mainz, 55131

  • Universitatsmedizin Mannheim

    Mannheim, 68167

  • Local Institution - 0096

    München, 81377

  • Local Institution - 0008

    Tübingen, 72076

  • Local Institution

    Würzburg, 97078

Other trials in Germany

South Korea12 sites

  • Local Institution - 0177

    Daegu, 41944

  • Local Institution - 0190

    Goyang-si, 10408

  • Local Institution - 0188

    Gyeongsangnam-do, 50612

  • Local Institution - 0178

    Jeollanam-do, 58128

  • Local Institution - 0169

    Seongnam-si, 13620

  • Local Institution - 0127

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

  • Local Institution - 0128

    Seoul, 03080

  • Local Institution - 0168

    Seoul, 03722

  • Local Institution - 0167

    Seoul, 05505

  • Local Institution - 0195

    Seoul, 06591

  • Local Institution - 0189

    Seoul, 08308

  • Local Institution - 0191

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Italy11 sites

  • Local Institution - 0102

    Bologna, 40138

  • Local Institution - 0077

    Florence, 50134

  • Local Institution - 0104

    Meldola, 47014

  • Local Institution - 0136

    Messina, ME, 98125

  • Local Institution - 0091

    Milan, 20133

  • Local Institution

    Modena, 41124

  • Local Institution - 0134

    Monserrato, 09042

  • Local Institution - 0101

    Naples, 80131

  • Local Institution - 0119

    Naples, 80131

  • Local Institution - 0103

    Padova, 35128

  • Local Institution - 0125

    Rome, 00168

Other trials in Italy

Spain11 sites

  • Local Institution - 0069

    Barcelona, 08035

  • Local Institution - 0031

    Barcelona, 08036

  • Local Institution - 0016

    Córdoba, 14004

  • Local Institution - 0072

    Donostia / San Sebastian, 20014

  • Local Institution - 0199

    Madrid, 28007

  • Local Institution - 0109

    Madrid, 28046

  • Local Institution - 0100

    Pamplona, 31008

  • Local Institution - 0010

    Sabadell (Barcelona), 08208

  • Local Institution - 0028

    Seville, 41013

  • Local Institution - 0082

    Valencia, 46026

  • Local Institution - 0097

    Zaragoza, 50009

Other trials in Spain

Taiwan10 sites

  • Local Institution - 0204

    Kaohsiung City, 883

  • Local Institution - 0130

    Taichung, 40447

  • Local Institution - 0140

    Taichung, 40705

  • Local Institution - 0131

    Tainan, TNN, 704

  • Local Institution - 0174

    Tainan, 736

  • Local Institution - 0207

    Taipei, 100

  • Local Institution - 0173

    Taipei, 105

  • Local Institution - 0129

    Taipei, 11217

  • Local Institution - 0175

    Taoyuan, 333

  • Local Institution - 0176

    Yunlin, 632

Other trials in Taiwan

Australia7 sites

  • Local Institution - 0164

    Adelaide, South Australia, 5000

  • Local Institution - 0239

    Blacktown, New South Wales, 2148

  • Local Institution - 0166

    Camperdown, New South Wales, 2050

  • Local Institution - 0141

    Concord, New South Wales, 2139

  • Local Institution - 0224

    Heidelberg, Victoria, 3084

  • Local Institution - 0220

    Herston, Queensland, 4029

  • Local Institution - 0124

    Nedlands, Western Australia, 6009

Other trials in Australia

Brazil7 sites

  • Local Institution - 0275

    Barretos, São Paulo, 14780-070

  • Local Institution - 0090

    Belo Horizonte, Minas Gerais, 30130-090

  • Local Institution - 0237

    Cerqueira César, São Paulo, 01246-000

  • Local Institution

    São José do Rio Preto, São Paulo, 15090-000

  • Local Institution

    São Paulo, São Paulo, 08270-120

  • Local Institution - 0023

    São Paulo, 01308-050

  • Local Institution - 0236

    São Paulo, 01509-010

Other trials in Brazil

Romania6 sites

  • Local Institution

    Brasov, 500091

  • Local Institution - 0078

    Bucharest, 022328

  • Local Institution - 0232

    Cluj-Napoca, 400015

  • Local Institution - 0242

    Constanța, 900591

  • Local Institution - 0074

    Craiova, 200542

  • Local Institution - 0070

    Timișoara, 300166

Other trials in Romania

Belgium5 sites

  • Local Institution - 0033

    Brussels, 1070

  • Local Institution - 0064

    Brussels, 1200

  • Local Institution - 0068

    Edegem, 2650

  • Local Institution - 0071

    Ghent, 9000

  • Local Institution - 0108

    Leuven, 3000

Other trials in Belgium

United Kingdom5 sites

  • Local Institution - 0111

    London, NW3 2QG

  • Local Institution - 0092

    London, SE5 9RS

  • Local Institution - 0153

    London, W12 0HS

  • Local Institution - 0114

    Manchester, M20 4BX

  • Local Institution - 0142

    Metropolitan Borough of Wirral, CH63 4JY

Other trials in United Kingdom

Chile4 sites

  • Local Institution - 0248

    Santiago, Santiago Metropolitan, 0

  • Local Institution - 0246

    Santiago, Santiago Metropolitan, 7710007

  • Local Institution - 0245

    Santiago, Santiago Metropolitan, 8380420

  • Local Institution - 0247

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Mexico4 sites

  • Local Institution - 0148

    Cuauhtémoc, Durango, 06700

  • Local Institution - 0121

    Monterrey, Nuevo León, 64000

  • Local Institution - 0264

    Monterrey, Nuevo León, 64460

  • Local Institution - 0226

    San Luis Potosí City, 78250

Other trials in Mexico

Russia4 sites

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045

  • Local Institution

    Leningrad Region, 188663

  • Local Institution - 0230

    Moscow, 115478

  • Local Institution - 0032

    Saint Petersburg, Sankt-Peterburg, 198255

Other trials in Russia

Argentina3 sites

  • Local Institution - 0243

    Gorriti, Buenos Aires, 5737

  • Local Institution - 0254

    Pilar, Buenos Aires, 1629

  • Local Institution - 0244

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Austria3 sites

  • Local Institution - 0012

    Graz, 8036

  • Local Institution - 0003

    Vienna, 1090

  • Local Institution - 0001

    Vienna, 1100

Other trials in Austria

Singapore3 sites

  • Local Institution - 0042

    Singapore, 119228

  • Local Institution - 0067

    Singapore, 169610

  • Local Institution - 0039

    Singapore, 308433

Other trials in Singapore

Canada2 sites

  • Local Institution

    Calgary, Alberta, T2N 4Z6

  • Local Institution - 0116

    Edmonton, T6G 1Z2

Other trials in Canada

Hong Kong2 sites

  • Local Institution - 0120

    Hong Kong, 999077

  • Local Institution - 0076

    Hong Kong

Other trials in Hong Kong

Netherlands2 sites

  • Local Institution - 0263

    Maastricht, 6229 HX

  • Local Institution - 0260

    Utrecht, 3584CX

Other trials in Netherlands

Colombia1 site

  • Local Institution - 0256

    Bogotá, 0

Other trials in Colombia

New Zealand1 site

  • Local Institution - 0240

    Auckland, 1023

Other trials in New Zealand

Puerto Rico1 site

  • Local Institution - 0231

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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

Being tested
Nivolumab, Placebo
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called Opdivo, BMS-936558

    Specified dose on specified days

  • PlaceboOther

    specified dose on specified days

Study groups in NCT03383458
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Biological: Nivolumab
Arm BPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-free Survival (RFS)

    Measured: Up to 49 months

Secondary outcomes (2)

  1. Overall Survival (OS)

    Measured: Up to 7 years

  2. Time to recurrence (TTR)

    Measured: Up to 49 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2017
  2. Study start18 Apr 2018
  3. Primary completion27 May 2026
  4. Study completion27 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03383458
Sponsor's protocol ID
CA209-9DX
Acronym
CheckMate 9DX
Status last verified
Jul 2026
First submitted
21 Dec 2017
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab in people with Hepatocellular Carcinoma and Liver Cancer, run by Bristol-Myers Squibb at 184 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Japan, France, Germany, South Korea and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free Survival (RFS) (time frame: Up to 49 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03383458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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