Advanced Hepatocellular Carcinoma
Conditions
Brief summary
Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Detailed description
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation, Incidence of clinically significant changes in clinical laboratory results: Hematology, Clinical Chemistry and Urinalysis tests, Disease control rate (DCR), Duration of response (DOR) and Progression-free survival assessed by BICR per RECIST v1.1, ORR, DCR, DOR and PFS assessed by investigator per RECIST v1.1, Overall survival (OS)
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGRelatlimab
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation, Incidence of clinically significant changes in clinical laboratory results: Hematology, Clinical Chemistry and Urinalysis tests, Disease control rate (DCR), Duration of response (DOR) and Progression-free survival assessed by BICR per RECIST v1.1, ORR, DCR, DOR and PFS assessed by investigator per RECIST v1.1, Overall survival (OS) | — |
Countries
Czechia, France, Poland, Romania, Spain
Outcome results
None listed