A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200442

Enrollment

Registered

2021-03-25

Start date

2021-02-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma

Interventions

Arm A: Nivolumab Arm B: Nivolumab+Relatlimab dose 1 Arm C: Nivolumab+Relatlimab dose 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Must have a diagnosis of hepatocellular carcinoma(HCC)based on histological confirmation - Must have advanced/metastatic HCC - Have to be immunotherapy treatment-naive; no prior immunotherapies are permitted - Must have at least one Response Evaluation Criteria in Solid Tumors(RECIST)v1.1 measurable untreated lesion - Child-Pugh score of 5 or 6 - Eastern Cooperative Oncology Group(ECOG)performance status 0 or 1 for ECOG performance status scale

Exclusion criteria

Exclusion criteria: - Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma - Prior organ allograft or allogeneic bone marrow transplantation - No uncontrolled or significant cardiovascular disease - No active known autoimmune disease

Design outcomes

Primary

Measure	Time frame
- ORR assessed by BICR using RECIST v1.1	—

Secondary

Measure	Time frame
- Incidence of AEs, SAEs, AEs leading to discontinuation, death and clinically significant changes in clinical laboratory results - DCR, DOR, and PFS assessed by BICR and Investigator - ORR asessed by Investigator - OS - Actual dose - BOR assessed by BICR - LAG-3 expression	—

Countries

Argentina, Australia, Brazil, Chile, China, Colombia, Czechia, France, Hong Kong, Japan, Korea, Mexico, New Zealand, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey

Contacts

Public ContactCallejo David

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026