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
Phase 2
- Conditions
- Advanced Hepatocellular Carcinoma
- Registration Number
- JPRN-jRCT2031200442
- Lead Sponsor
- David Perez Callejo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - ORR assessed by BICR using RECIST v1.1
- Secondary Outcome Measures
Name Time Method - Incidence of AEs, SAEs, AEs leading to discontinuation, death and clinically significant changes in clinical laboratory results<br>- DCR, DOR, and PFS assessed by BICR and Investigator<br>- ORR asessed by Investigator<br>- OS<br>- Actual dose<br>- BOR assessed by BICR<br>- LAG-3 expression