Carcinoma, Hepatocellular
Conditions
Keywords
Hepatocellular Carcinoma, HCC, Liver Cancer, Relatlimab, Nivolumab, Bevacizumab, First line HCC
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).
Interventions
DRUGRelatlimab
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
DRUGBevacizumab
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC) * Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team) * Child-Pugh score of 5 or 6 (ie, Child-Pugh A) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion criteria
* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC * Prior allogenic stem cell or solid organ transplantation * Untreated symptomatic central nervous system (CNS) metastases * Clinically significant ascites as defined by: i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLTs) | Up to 6 weeks |
| Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Assessed up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| OS of all randomized participants that are LAG-3 positive | Assessed up to 3 years |
| Number of participants with adverse events (AEs) | Up to 135 days after participant's last dose |
| ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive | Assessed up to 3 years |
| PFS by BICR per RECIST v1.1 in all randomized participants | Assessed up to 3 years |
| Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive | Assessed up to 3 years |
| Overall Survival (OS) of all randomized participants | Assessed up to 3 years |
Countries
Australia, Canada, China, France, Germany, Hong Kong, Italy, Japan, Poland, Puerto Rico, Singapore, South Korea, Spain, Taiwan, United States
Outcome results
None listed