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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Liver Cell Carcinoma, Adult

Liver Cancer, Adult

Hepatocellular Carcinoma

Liver Cell Carcinoma

Hepatoma

Treatments

Biological: Relatlimab

Biological: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04567615

2018-003151-38 (EudraCT Number)

CA224-073

U1111-1218-6499 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety 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 inhibitor therapy.

Enrollment

266 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 in the advanced/metastatic setting
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

Key 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
Have received one or two lines of tyrosine kinase inhibitor therapies
Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy

Other protocol-defined inclusion/exclusion criteria apply