Advanced/metastatic hepatocellular carcinoma (HCC) MedDRA version: 20.0 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: relatlimab - 130 mg/ml
Product Code: BMS-986016
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: relatlimab
Other descriptive name: BMS-986016
Concentration unit
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years of age - previously untreated for advanced/metastatic HCC - ECOG 0-1 - Child-Pugh A - Barcelona Clinical Liver Cancer stage B or C For detailed inclusion criteria, please refer to clinical protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 129 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: - fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - prior disease history with increased risk of bleeding - clinically significant ascites - use of anticoagulant therapies For detailed exclusion criteria, please refer to clinical protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine the RP2D (recommended Phase 2 dose) of relatlimab, nivolumab, and bevacizumab triplet combination in participants with advanced/metastatic HCC (hepatocellular carcinoma) who have not received prior systemic therapy - To evaluate ORR (objective response rate) of the relatlimab, nivolumab, and bevacizumab triplet combination relative to nivolumab and bevacizumab doublet combination in all randomized participants with advanced/metastatic HCC who have not received prior systemic therapy;Secondary Objective: - To estimate key efficacy endpoints of the relatlimab, nivolumab, and bevacizumab triplet combination and the nivolumab and bevacizumab in doublet combination in all randomized participants with advanced/metastatic HCC who have not received prior systemic therapy and all randomized participants who express LAG-3 (lymphocyte activation gene-3) (= 1%) by immunohistochemistry (IHC) - To determine the safety and tolerability of the relatlimab, nivolumab, and bevacizumab triplet combination in all treated participants with advanced/metastatic HCC who have not received prior systemic therapy;Primary end point(s): 1/ DLTs (dose-limiting toxicities) assessed by Investigator within a 6-week DLT window for the first approximately 12, 24, 36, or 48 treated participants in 2 arms combined, depending on data 2/ ORR (objective response rate) assessed by BICR using RECIST v1.1;Timepoint(s) of evaluation of this end point: 1/ 6-week DLT window after first dose date or until a DLT is observed in both relatlimab and bevacizumab (if it occurs less than 6 weeks) 2/ Tumor assessments should continue until disease progression (including progression on treatment beyond initial progression) or death or consent withdrawal, whichever is earlier, up to 5 years after last participant randomized | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ - PFS assessed by BICR using RECIST v1.1 in all randomized participants - PFS assessed by BICR using RECIST v1.1 in all randomized LAG-3 positive (= 1% by IHC) participants - ORR assessed by BICR using RECIST v1.1 in all randomized LAG-3 positive (= 1% by IHC) participants - Overall Survival (OS) in all randomized participants - OS in all randomized LAG-3 positive (= 1% by IHC) participants 2/ Adverse Events (AEs), Serious Adverse Events (SAEs), select AEs, IMAEs (Immune-Mediated Adverse Events), related or not, from first dose to 30- or 135-days after the last dose;Timepoint(s) of evaluation of this end point: 1/ PFS: When approximately 98 PFS events have ocurred. ORR: Same Timeframe as primary endpoint OS: Up to 5 years after last participant randomized 2/ from first dose to 135-days after the last dose | — |
Countries
Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Poland, Singapore, Spain, Taiwan, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed