TriangleNCT04039607 · CITED IN SOURCE DOCUMENTS
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2026-08-25
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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 Exclusion Criteria: * 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Nivolumab
- Drug: Ipilimumab
- label
- Nivolumab + Ipilimumab
- type
- EXPERIMENTAL
- intervention Names
- Drug: Sorafenib
- Drug: lenvatinib
- label
- Sorafenib/lenvatinib
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Nivolumab + Ipilimumab
- description
- Participants will receive nivolumab as intravenous (IV) infusion.
- name
- Nivolumab
- type
- DRUG
- arm Group Labels
- Nivolumab + Ipilimumab
- description
- Participants will receive ipilimumab as IV infusion.
- name
- Ipilimumab
- type
- DRUG
- arm Group Labels
- Sorafenib/lenvatinib
- description
- Participants will receive sorafenib as oral tablets.
- name
- Sorafenib
- type
- DRUG
- arm Group Labels
- Sorafenib/lenvatinib
- description
- Participants will receive lenvatinib as oral capsules.
- name
- lenvatinib
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 732
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Overall Survival (OS)
- time Frame
- Up to 4 years
- secondary Outcomes
- measure
- Objective Response Rate (ORR)
- time Frame
- Up to 4 years
- measure
- Duration of Response (DOR)
- time Frame
- Up to 4 years
- measure
- Time to Symptom Deterioration (TTSD)
- time Frame
- Up to 4 years
Full study description
- brief 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.
Source references
- references
- citation
- 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.
- pmid
- 41981891
- type
- DERIVED
- citation
- 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.
- pmid
- 40349714
- type
- DERIVED
- citation
- 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.
- pmid
- 38038862
- type
- DERIVED
- see Also Links
- label
- BMS Clinical Trial Information
- label
- BMS Clinical Trial Patient Recruiting
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-5a14893563f8110aa583
- requested nct id
- NCT04039607
- primary nct id
- NCT04039607
- source kind
- fda_approval_notice
- source record id
- fda-5a12fc6862fd1c47
- source file sha256
- 1325311625e83f611cace9e4ddbbea4f65799c374ae5b17b2af05559572a7172
- payload sha256
- 4ef9c8b1e08fc3584477d268970b2fa79ccc9f853e5861cfac33a5feb6140e0f
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-5a14893563f8110aa583
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT04039607
- occurrences
- context exact
- n <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>.</p><h2>Efficacy and Safety</h2><p>Efficacy was evaluated in CHECKMATE-9DW (NCT04039607), a randomized (1:1), open-label trial in 668 adults with unresectable or metastatic HCC. Patients had histologically confirmed HCC, Child Pugh Class A, ECOG p
- end
- 24764
- exact text
- NCT04039607
- start
- 24753
- offset unit
- unicode_code_points
- source event date
- 2025-04-11
- source file
- /tmp/cancer-full-research/updates/pages/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma.html
- source file sha256
- 1325311625e83f611cace9e4ddbbea4f65799c374ae5b17b2af05559572a7172
- source json pointer
- Source null
- source kind
- fda_approval_notice
- source record id
- fda-5a12fc6862fd1c47
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- 1325311625e83f611cace9e4ddbbea4f65799c374ae5b17b2af05559572a7172
- source title
- FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-92b41dfb3810c70b569a
- requested nct id
- NCT04039607
- primary nct id
- NCT04039607
- source kind
- fda_spl_label
- source record id
- 1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
- source file sha256
- 0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
- payload sha256
- 759f2e11230e8204a7538b31a882a663c62b5145387d0717498a9b7dcc345b68
- payload
- application numbers
- BLA761381
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-92b41dfb3810c70b569a
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT04039607
- occurrences
- context exact
- cription of the efficacy results of the adequate and well-controlled study of intravenous nivolumab in this hepatocellular carcinoma population. CHECKMATE-9DW (NCT04039607) was a randomized (1:1), open-label trial in adults (18 years of age or older) with unresectable or metastatic HCC. Patients had histologically confirmed HCC,
- end
- 85668
- exact text
- NCT04039607
- start
- 85657
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00000.json
- source file sha256
- 0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
- source json pointer
- /results/99/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 5bf2986a82b5a92531e13372f09d8e1a224755d4292be776af9561e28041e8bb
- spl effective time
- 20260512
- spl set id
- 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-bae455189f206d122bdc
- requested nct id
- NCT04039607
- primary nct id
- NCT04039607
- source kind
- fda_spl_label
- source record id
- 1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
- source file sha256
- fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
- payload sha256
- 47077ee000a76cc62570e554398e75a01f777a964f5953eb1eac45b99cae794b
- payload
- application numbers
- BLA125554
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-bae455189f206d122bdc
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT04039607
- occurrences
- context exact
- 2 months response duration 82% 88% 77% 74% 14.12 Hepatocellular Carcinoma Treatment of Unresectable or Metastatic Hepatocellular Carcinoma (HCC) CHECKMATE-9DW (NCT04039607) was a randomized (1:1), open-label trial in adults (18 years of age or older) with unresectable or metastatic HCC. Patients had histologically confirmed HCC,
- end
- 90993
- exact text
- NCT04039607
- start
- 90982
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00100.json
- source file sha256
- fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
- source json pointer
- /results/9/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 47f974766bb01dbde354e28e5e29eb6c7328d3adabf94e5593a5044bca4bc462
- spl effective time
- 20260812
- spl set id
- f570b9c4-6846-4de2-abfa-4d0a4ae4e394
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-d1df1e70ccfd06ab50b9
- requested nct id
- NCT04039607
- primary nct id
- NCT04039607
- source kind
- fda_spl_label
- source record id
- 72755838-4a55-4245-949e-16cea13f2584
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- payload sha256
- c0e21e7796e73e2765beaa08071272e8f37d61415afcc4cae808507b767f17e2
- payload
- application numbers
- BLA125377
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-d1df1e70ccfd06ab50b9
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT04039607
- occurrences
- context exact
- e-checkmate-8hw pfs-all-lines-checkmate-8hw 14.5 Hepatocellular Carcinoma Treatment of Unresectable or Metastatic Hepatocellular Carcinoma (HCC) CHECKMATE-9DW (NCT04039607) was a randomized (1:1), open-label trial in adults (18 years of age or older) with unresectable or metastatic HCC. Patients had histologically confirmed HCC,
- end
- 22806
- exact text
- NCT04039607
- start
- 22795
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00400.json
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- source json pointer
- /results/51/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 72755838-4a55-4245-949e-16cea13f2584
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 658a921a002e81a6b55202efcb78091c2f2526215217a47cb445aaf003f3b7ac
- spl effective time
- 20260820
- spl set id
- 2265ef30-253e-11df-8a39-0800200c9a66
Preserved source evidence · Not medical advice