AzTrials
AzTrials

Hepatocellular CarcinomaPhase 3CheckMate 9DWNCT04039607

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

A Phase 3 study testing Nivolumab, Ipilimumab and Sorafenib in people with Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 210 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Nivolumab, Ipilimumab and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
732 participants
Where
210 sitesin 26 countries
Study dates
30 Sep 2019to 9 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 must have a diagnosis of HCC based on histological confirmation
  • Participants must have an advanced HCC
  • Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
  • 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
  • Prior liver transplant
  • Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
  • Active brain metastases or leptomeningeal metastases
  • Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

210 sites in 26 countries.

210 sites in 26 countries

China27 sites

  • Local Institution - 0175

    Beijing, Beijing Municipality, 100000

  • Local Institution - 0152

    Beijing, Beijing Municipality, 100142

  • Local Institution - 0162

    Changchun, Jilin, 130021

  • Local Institution - 0166

    Changchun, Jilin, 130102

  • Local Institution - 0109

    Changsha, Hunan, 410006

  • Local Institution - 0059

    Changsha, Hunan, 410011

  • Local Institution - 0179

    Chongqing, Sichuan, 400030

  • Local Institution - 0131

    Dalian, Liaoning, 116023

  • Local Institution - 0151

    Fuzhou, Fujian, 350002

  • Local Institution - 0121

    Fuzhou, Fujian, 350014

  • Local Institution - 0125

    Guangzhou, Guangdong, 510000

  • Local Institution - 0150

    Guangzhou, Guangdong, 510515

  • Local Institution - 0108

    Hangzhou, Zhejiang, 310000

  • Local Institution - 0107

    Hangzhou, Zhejiang, 310022

  • Local Institution - 0135

    Harbin, Heilongjiang, 150081

  • Local Institution - 0120

    Hefei, Anhui, 230022

  • Local Institution - 0146

    Hefei, Anhui, 230601

  • Local Institution - 0145

    Nanchang, Jiangxi, 330006

  • Local Institution - 0149

    Nanchang, Jiangxi, 330019

  • Local Institution - 0130

    Nanjing, Jiangsu, 210002

  • Local Institution - 0153

    Qingdao, Shandong, 266000

  • Local Institution - 0134

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0123

    Shenyang, Liaoning, 110004

  • Local Institution - 0132

    Shenyang, Liaoning, 110117

  • Local Institution - 0133

    Xi'an, Shaanxi, 710038

  • Local Institution - 0147

    Xi'an, Shan3xi, 710061

  • Local Institution - 0307

    Xi'an, Shan3xi, 710100

Other trials in China

Japan20 sites

  • Local Institution - 0263

    Abeno-ku, Osaka, 5458586

  • Local Institution - 0204

    Chiba, 260-8677

  • Local Institution - 0178

    Fukuoka, 830-0011

  • Local Institution - 0177

    Hiroshima, 7348551

  • Local Institution - 0258

    Iruma-gun, Saitama, 3500495

  • Local Institution - 0259

    Izunokuni-shi, Shizuoka, 410-2295

  • Local Institution - 0176

    Kanazawa, Ishikawa-ken, 920-8641

  • Local Institution - 0261

    Kashihara, Nara, 634-8522

  • Local Institution - 0193

    Kashiwa-shi, Chiba, 2778577

  • Local Institution - 0189

    Kyoto, Kyoto, 602-8566

  • Local Institution - 0203

    Matsuyama, Ehime, 790-0024

  • Local Institution - 0128

    Minato, Tokyo, 105-8470

  • Local Institution - 0122

    Minato-ku, Tokyo, 105-8470

  • Local Institution - 0201

    Mitaka, Tokyo, 181-8611

  • Local Institution - 0199

    Musashino-shi, Tokyo, 180-8610

  • Local Institution - 0281

    Saga, Saga-ken, 8408571

  • Local Institution - 0155

    Sapporo, 0600033

  • Local Institution - 0127

    Sayama, Osaka, 5898511

  • Local Institution - 0200

    Yokohama, Kanagawa, 2320024

  • Local Institution - 0262

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States15 sites

  • Local Institution

    Ann Arbor, Michigan, 48105

  • Local Institution - 0190

    Baltimore, Maryland, 21287

  • Local Institution - 0288

    Coronado, California, 92118

  • Local Institution - 0304

    Dallas, Texas, 75203

  • Local Institution - 0018

    Detroit, Michigan, 48202

  • Local Institution - 0157

    Duarte, California, 91010-3012

  • Local Institution - 0202

    Houston, Texas, 77030

  • Local Institution - 0027

    Louisville, Kentucky, 40217

  • Local Institution - 0046

    Lubbock, Texas, 79410

  • Local Institution - 0295

    Newark, New Jersey, 07103

  • Local Institution - 0284

    Pittsburgh, Pennsylvania, 15212

  • Local Institution - 0172

    Salt Lake City, Utah, 84106

  • Local Institution - 0043

    Toledo, Ohio, 43623

  • Local Institution - 0292

    Tucson, Arizona, 85719

  • Local Institution - 0077

    Washington D.C., District of Columbia, 20007

Other trials in United States

France14 sites

  • Local Institution - 0068

    Amiens, 80054

  • Local Institution - 0116

    Caen, 14033

  • Local Institution - 0069

    Clichy, 92110

  • Local Institution - 0138

    Dijon, 21000

  • Local Institution - 0081

    Grenoble, 38043

  • Local Institution - 0070

    Lyon, 69004

  • Local Institution

    Marseille, 13009

  • Local Institution - 0082

    Montpellier, 34295

  • Local Institution - 0067

    Nice, 6202

  • Local Institution - 0025

    Pessac, 33604

  • Local Institution - 0137

    Poitiers, 86021

  • Local Institution - 0042

    Toulouse, 31059

  • Local Institution - 0071

    Vandœuvre-lès-Nancy, 54500

  • Local Institution - 0051

    Villejuif, 94800

Other trials in France

Brazil13 sites

  • Local Institution - 0181

    Brasília, Federal District, 70200-730

  • Local Institution - 0279

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0054

    Jaú, São Paulo, 17210-120

  • Local Institution - 0016

    Paranã, 81520-060

  • Local Institution - 0060

    Pelotas, Rio Grande do Sul, 96020-360

  • Local Institution - 0015

    Rio de Janeiro, 22793-080

  • Local Institution

    Salvador, Estado de Bahia, 41253190

  • Local Institution - 0061

    Salvador, Estado de Bahia, 41950-640

  • Hospital de Base de Sao Jose do Rio Preto

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

  • Local Institution - 0023

    São Paulo, 01246-000

  • Local Institution - 0022

    São Paulo, 01323-900

  • Local Institution - 0050

    São Paulo, 04038-034

  • Local Institution - 0278

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Germany12 sites

  • Local Institution - 0231

    Bonn, 53127

  • Local Institution - 0028

    Cologne, 50937

  • Local Institution - 0052

    Essen, 45147

  • Local Institution - 0005

    Frankfurt am Main, Hesse, 60590

  • Local Institution - 0185

    Freiburg im Breisgau, 79106

  • Local Institution - 0006

    Hamburg, 20246

  • Local Institution - 0102

    Hanover, 30625

  • Local Institution - 0118

    Leipzig, 04103

  • Local Institution - 0031

    Mainz, 55131

  • Local Institution - 0056

    Mannheim, 68167

  • Local Institution

    München, 81675

  • Local Institution - 0053

    North Rhine-Westphalia, 45136

Other trials in Germany

Spain12 sites

  • Local Institution - 0297

    Barcelona, 08035

  • Local Institution - 0055

    Barcelona, 08036

  • Local Institution - 0089

    Barcelona, 08908

  • Local Institution - 0090

    Córdoba, 14004

  • Local Institution - 0087

    El Palmar, 30120

  • Local Institution - 0041

    Madrid, 28007

  • Local Institution - 0093

    Madrid, 28028

  • Local Institution - 0290

    Madrid, 28035

  • Local Institution - 0045

    Majadahonda, 28222

  • Local Institution - 0085

    Pamplona, 31008

  • Local Institution - 0088

    Santander, 39008

  • Local Institution - 0040

    Zaragoza, 50009

Other trials in Spain

Italy11 sites

  • Local Institution - 0084

    Candiolo, 10060

  • Local Institution - 0110

    Meldola, Forli-Cesena, 47014

  • Local Institution - 0039

    Milan, 20122

  • Local Institution - 0100

    Novara, 28100

  • Local Institution - 0219

    Padova, 35128

  • Local Institution - 0033

    Parma, 43126

  • Local Institution - 0112

    Roma, 00128

  • Local Institution - 0079

    Rome, 00168

  • Local Institution - 0101

    Rozzano, Milano, 20089

  • Local Institution - 0111

    Siena, 53100

  • Local Institution - 0044

    Vicenza, 36100

Other trials in Italy

Australia10 sites

  • Local Institution - 0009

    Adelaide, South Australia, 5000

  • Local Institution - 0004

    Birtinya, Queensland, 4560

  • Local Institution - 0019

    Clayton, Victoria, 3168

  • Local Institution - 0026

    Fitzroy, Victoria, 3065

  • Local Institution - 0013

    Herston, Queensland, 4029

  • Local Institution - 0003

    Kogarah, New South Wales, 2217

  • Local Institution - 0038

    Liverpool, New South Wales, 1871

  • Local Institution - 0001

    Melbourne, Victoria, 3004

  • Local Institution - 0020

    St Albans, Victoria, 3021

  • Local Institution - 0002

    Westmead, New South Wales, 2145

Other trials in Australia

South Korea9 sites

  • Local Institution - 0142

    Busan, 49241

  • Local Institution - 0167

    Guro-gu, Seoul, 8308

  • Local Institution - 0097

    Gyeonggi-do, 010408

  • Local Institution - 0098

    Gyeongsangnam-do, 050612

  • Local Institution - 0062

    Jongno-gu, Seoul, 03080

  • Local Institution - 0143

    Seongnam-si, Gyeonggi-do, 13496

  • Local Institution - 0141

    Seoul, 03722

  • Local Institution - 0140

    Seoul, 05505

  • Local Institution - 0139

    Seoul, 06351

Other trials in South Korea

Taiwan9 sites

  • Local Institution - 0272

    Kaohsiung City, 807

  • Local Institution - 0096

    Kaohsiung City, 83301

  • Local Institution - 0105

    Taichung, 40447

  • Local Institution - 0271

    Taichung, 40705

  • Local Institution - 0168

    Tainan, 704

  • Local Institution - 0270

    Tainan, 736

  • Local Institution - 0144

    Taipei, 10002

  • Local Institution - 0078

    Taipei, 11266

  • Local Institution - 0173

    Taoyuan, 333

Other trials in Taiwan

Chile8 sites

  • Local Institution - 0094

    La Serena, Coquimbo Region, 1720430

  • Local Institution - 0283

    Santiago, RM, 7630372

  • Local Institution - 0095

    Santiago, Santiago Metropolitan, 0

  • Local Institution - 0024

    Santiago, Santiago Metropolitan, 7710007

  • Local Institution - 0156

    Santiago, Santiago Metropolitan, 8380456

  • Local Institution - 0296

    Temuco, Araucania, 4780000

  • Local Institution - 0012

    Viña del Mar, Valparaiso, 2520598

  • Local Institution - 0216

    Viña del Mar, Valparaiso, 2540402

Other trials in Chile

Russia8 sites

  • Local Institution - 0029

    Arkhangelsk, 163045

  • Local Institution - 0066

    Barnaul, 656045

  • Local Institution - 0074

    Chelyabinsk, 454087

  • Local Institution - 0007

    Moscow, 115478

  • Local Institution - 0072

    Pyatigorsk, 357502

  • Local Institution - 0075

    Saint Petersburg, 197758

  • Local Institution - 0091

    Saint Petersburg, 198255

  • Local Institution - 0073

    Sochi, 354057

Other trials in Russia

Belgium7 sites

  • Local Institution - 0034

    Brussels, 1070

  • Local Institution - 0008

    Federal District, 72115700

  • Local Institution - 0124

    Ghent, 9000

  • Local Institution - 0298

    Ghent, 9000

  • Local Institution - 0099

    Haine-Saint-Paul, 7100

  • Local Institution - 0064

    Leuven, 3000

  • Local Institution - 0104

    Liège, 4000

Other trials in Belgium

Argentina5 sites

  • Local Institution - 0136

    Buenos Aires, C1426ANZ

  • Local Institution - 0037

    Caba, Buenos Aires, C1090AAS

  • Local Institution - 0194

    Pilar, Buenos Aires, B1629ODT

  • Local Institution - 0282

    Rosario, Santa Fe Province, 2000

  • Local Institution - 0058

    San Miguel de Tucumán, 4000

Other trials in Argentina

Austria5 sites

  • Local Institution - 0188

    Graz, 8036

  • Local Institution - 0065

    Klagenfurt, 9020

  • Local Institution - 0114

    Sankt Pölten, Lower Austria, 3100

  • Local Institution - 0186

    Vienna, 1090

  • Local Institution - 0057

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

Romania5 sites

  • Local Institution - 0164

    Bucharest, 022328

  • Local Institution - 0165

    Cluj-Napoca, 400015

  • Local Institution - 0103

    Craiova, Dolj, 200542

  • Local Institution

    Craiova, 200385

  • Local Institution - 0163

    Timișoara, 300166

Other trials in Romania

United Kingdom4 sites

  • Local Institution - 0160

    Edinburgh, EH4 2XU

  • Local Institution - 0154

    Guildford, Surrey, GU2 7XX

  • Local Institution - 0171

    London, Greater London, W12 OHS

  • Local Institution - 0129

    London, SE5 9RS

Other trials in United Kingdom

Poland3 sites

  • Local Institution - 0148

    Gdansk, 80219

  • Local Institution - 0049

    Otwock, 05-400

  • Local Institution - 0092

    Warsaw, 02-034

Other trials in Poland

Singapore3 sites

  • Local Institution - 0048

    Singapore, 168583

  • Local Institution - 0017

    Singapore, 258499

  • Local Institution - 0174

    Singapore, 308442

Other trials in Singapore

Czechia2 sites

  • Local Institution

    Brno, 60200

  • Local Institution - 0274

    Prague, Prague, 14059

Other trials in Czechia

Hong Kong2 sites

  • Local Institution - 0036

    Hong Kong, 999077

  • Local Institution - 0032

    Hong Kong

Other trials in Hong Kong

New Zealand2 sites

  • Local Institution - 0047

    Auckland, 1023

  • Local Institution - 0286

    Christchurch, Canterbury, 8011

Other trials in New Zealand

Puerto Rico2 sites

  • Local Institution - 0289

    Rio Piedras, 00935

  • Local Institution - 0035

    San Juan, 00927-4308

Other trials in Puerto Rico

Canada1 site

  • Local Institution - 0192

    Edmonton, Alberta, T6G 1Z2

Other trials in Canada

Switzerland1 site

  • Local Institution - 0063

    Bern, 3010

Other trials in Switzerland

About this study

Official title: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • NivolumabDrug

    Participants will receive nivolumab as intravenous (IV) infusion.

  • IpilimumabDrug

    Participants will receive ipilimumab as IV infusion.

  • SorafenibDrug

    Participants will receive sorafenib as oral tablets.

  • lenvatinibDrug

    Participants will receive lenvatinib as oral capsules.

Study groups in NCT04039607
Study groupRoleWhat they receive
Nivolumab + IpilimumabExperimentalNot described
Receives: Drug: Nivolumab; Drug: Ipilimumab
Sorafenib/lenvatinibActive comparatorNot described
Receives: Drug: Sorafenib; Drug: lenvatinib

What is being measured

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

  1. Overall Survival (OS)

    Measured: Up to 4 years

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    Measured: Up to 4 years

  2. Duration of Response (DOR)

    Measured: Up to 4 years

  3. Time to Symptom Deterioration (TTSD)

    Measured: Up to 4 years

Timeline

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

  1. First posted31 Jul 2019
  2. Study start30 Sep 2019
  3. Primary completion9 Jul 2026
  4. Study completion9 Jul 2026

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
None (open label)
Enrolment
732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04039607
Sponsor's protocol ID
CA209-9DW
Acronym
CheckMate 9DW
Status last verified
Aug 2026
First submitted
30 Jul 2019
Last updated
25 Aug 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

Publications

  • Yau T, Galle PR, Decaens T, Sangro B, Qin S, da Fonseca LG, Karachiwala H, Blanc JF, Park JW, Gane E, Pinter M, Matilla Pena A, Ikeda M, Tai D, Santoro A, Pizarro G, Chiu CF, Schenker M, He A, Chon HJ, Wojcik-Tomaszewska J, Verset G, Wang QQ, Stromko C, Neely J, Singh P, Jimenez Exposito MJ, Kudo M. A plain language summary of the CheckMate 9DW study: nivolumab in combination with ipilimumab for unresectable hepatocellular carcinoma (advanced liver cancer). Future Oncol. 2026 Apr;22(10):1135-1152. doi: 10.1080/14796694.2026.2651375. Epub 2026 Apr 14.

    PubMed 41981891

  • Yau T, Galle PR, Decaens T, Sangro B, Qin S, da Fonseca LG, Karachiwala H, Blanc JF, Park JW, Gane E, Pinter M, Pena AM, Ikeda M, Tai D, Santoro A, Pizarro G, Chiu CF, Schenker M, He A, Chon HJ, Wojcik-Tomaszewska J, Verset G, Wang QQ, Stromko C, Neely J, Singh P, Jimenez Exposito MJ, Kudo M; CheckMate 9DW investigators. Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial. Lancet. 2025 May 24;405(10492):1851-1864. doi: 10.1016/S0140-6736(25)00403-9. Epub 2025 May 8.

    PubMed 40349714

  • Huynh JC, Cho M, Monjazeb A, Al-Obeidi E, Singh A, Tam K, Lara F, Martinez A, Garcia L, Kim EJ. Phase I/II trial of BMS-986,205 and nivolumab as first line therapy in hepatocellular carcinoma. Invest New Drugs. 2024 Feb;42(1):35-43. doi: 10.1007/s10637-023-01416-w. Epub 2023 Dec 1.

    PubMed 38038862

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Ipilimumab and Sorafenib in people with Hepatocellular Carcinoma, run by Bristol-Myers Squibb at 210 sites in 26 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in China, Japan, United States, France, Brazil and 21 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (OS) (time frame: Up to 4 years). 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 NCT04039607, which also lists 3 linked publications.

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 25 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in