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

Conditions

Hepatocellular Carcinoma

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.

Aiwu Ruth He, P R Galle, B Sangro, Thomas Decaens, Masatoshi Kudo et al. (18 authors)

Journal of Clinical Oncology2026-05-27

10.1200/jco.2026.44.16_suppl.4104

Nivolumab plus ipilimumab vs lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (HCC): 4-year follow-up of CheckMate 9DW.

Peter Robert Galle, Bruno Sangro, Marine Faure, Kenichi Ido, Shukui Qin et al. (17 authors)

Journal of Clinical Oncology2026-01-10

10.1200/jco.2026.44.2_suppl.lba479

Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial.

Yau T, Galle PR, Decaens T, Sangro B, Qin S, da Fonseca LG, Karachiwala H, Blanc JF, Park JW, Gane E, Pinter M, Peña 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.

2025-05-0880 citations

10.1016/s0140-6736(25)00403-9

Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line (1L) therapy for unresectable hepatocellular carcinoma (uHCC): CheckMate 9DW expanded analyses.

Masatoshi Kudo, Thomas Yau, Thomas Decaens, Bruno Sangro, Shukui Qin et al. (20 authors)

Journal of Clinical Oncology2025-01-279 citations

10.1200/jco.2025.43.4_suppl.520

Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC): First results from CheckMate 9DW.

Peter R. Galle, Thomas Decaens, Masatoshi Kudo, Shukui Qin, Leonardo Goliatt et al. (20 authors)

Journal of Clinical Oncology2024-06-05135 citations

10.1200/jco.2024.42.17_suppl.lba4008

Safety, Efficacy, and Pharmacodynamics of Tremelimumab Plus Durvalumab for Patients With Unresectable Hepatocellular Carcinoma: Randomized Expansion of a Phase I/II Study

Robin Kate Kelley, Bruno Sangro, William Proctor Harris, Masafumi Ikeda, Takuji Okusaka et al. (24 authors)

Journal of Clinical Oncology2021-07-22425 citations

10.1200/jco.20.03555

Back to the basics: How the preclinical rationale shapes the immunotherapy landscape for hepatocellular carcinoma

Antonio D’Alessio, Lorenza Rimassa

Liver Cancer International2021-05-011 citations

10.1002/lci2.24

Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib

Thomas Yau, Yoon‐Koo Kang, Tae‐You Kim, Anthony B. El-Khoueiry, Armando Santoro et al. (21 authors)

JAMA Oncology2020-10-021,165 citations

10.1001/jamaoncol.2020.4564

Interventions

DRUGNivolumab

Participants will receive nivolumab as intravenous (IV) infusion.

DRUGIpilimumab

Participants will receive ipilimumab as IV infusion.

DRUGSorafenib

Participants will receive sorafenib as oral tablets.

DRUGlenvatinib

Participants will receive lenvatinib as oral capsules.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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/

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	Up to 4 years

Secondary

Measure	Time frame
Objective Response Rate (ORR)	Up to 4 years
Duration of Response (DOR)	Up to 4 years
Time to Symptom Deterioration (TTSD)	Up to 4 years

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Italy, Japan, New Zealand, Poland, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed