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 (CA224-073)
Active, not recruiting
- Conditions
- Advanced Hepatocellular Carcinoma
- Registration Number
- jRCT2031200442
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not 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
- parallel assignment
- 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 不良事件（AEs）、严重不良事件（SAEs）、导致停药的不良事件、死亡以及临床实验室结果的临床显著变化的发生率
DCR, DOR, and PFS assessed by BICR and Investigator 由盲态独立中心审查（BICR）和研究者在评估的疾病控制率（DCR）、缓解持续时间（DOR）和无进展生存期（PFS）
ORR asessed by Investigator 由研究者评估的客观缓解率（ORR）
OS 总生存期（OS）
Actual dose 实际剂量
BOR assessed by BICR 由盲态独立中心审查（BICR）评估的最佳总体缓解（BOR）
LAG-3 expression LAG-3表达