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
- Trial number:
-
NCT04567615
- Trial phase:
- 2
- Study type:
- Immunotherapy, Targeted therapy
- Overall status:
- Recruiting
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 (RELATIVITY-073)
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.
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
Liver Cell Carcinoma, Adult, Hepatocellular Carcinoma, Hepatoma, Liver Cell Carcinoma, Liver Cancer, Adult
Other study ID numbers
CA224-073; 2018-003151-38; U1111-1218-6499
Choose trial site (70)
National Cancer Centre Singapore
Recruiting
11 Hospital Crescent, Singapore 169610
Tan Tock Seng Hospital Singapore
Not yet recruiting
11 Jln Tan Tock Seng, Level 1, Singapore 308433