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

# NCT04567615 Trial phase: 2 Overall status: Recruiting Study type: immunotherapy, targeted

Study Start Date

February, 2021

Scientific Title

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

Summary

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.

Inclusion Criteria

Exclusion Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Key - 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 Key

- 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 Other protocol-defined inclusion/exclusion criteria apply

Study Design

Primary purpose: Treatment , Allocation: Randomized , Intervention model: Parallel Assignment , Masking: None (Open Label),

Conditions

Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult

Other Study ID Numbers

CA224-073; 2018-003151-38

Locations

Local Institution, Argentina

Local Institution, Chile

Local Institution, Spain

Local Institution, Argentina

Local Institution, Australia

Local Institution, Brazil

Local Institution, Chile

Local Institution, Czechia

Hôpital Beaujon-Oncologie Digestive, France

Hopital De La Croix Rousse, France

Hopital Du Haut-Leveque, France

Local Institution, France

Local Institution, Hong Kong

Local Institution, Japan

Local Institution, Korea, Republic of

Local Institution, New Zealand

Local Institution, Poland

Local Institution, Romania

Local Institution, Russian Federation

Local Institution, Singapore

Local Institution, Spain

Local Institution, Taiwan

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