Description:
The purpose of this study is to evaluate the effectiveness and safety 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 inhibitor
therapy.
Title
- Brief Title: 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
- Official Title: A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)
Clinical Trial IDs
- ORG STUDY ID:
CA224-073
- SECONDARY ID:
2018-003151-38
- SECONDARY ID:
U1111-1218-6499
- NCT ID:
NCT04567615
Conditions
- Hepatocellular Carcinoma
- Hepatoma
- Liver Cancer, Adult
- Liver Cell Carcinoma
- Liver Cell Carcinoma, Adult
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | OPDIVO, BMS-936558 | Arm A : Nivolumab |
| Relatlimab | BMS-986016 | Arm B : Nivolumab + Relatlimab Dose 1 |
Purpose
The purpose of this study is to evaluate the effectiveness and safety 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 inhibitor
therapy.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm A : Nivolumab | Experimental | | |
| Arm B : Nivolumab + Relatlimab Dose 1 | Experimental | | |
| Arm C : Nivolumab + Relatlimab Dose 2 | Experimental | | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Key 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
Key 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
Other protocol-defined inclusion/exclusion criteria apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Time Frame: | Up to approximately 2 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Incidence of Adverse Events (AEs) |
| Time Frame: | Up to approximately 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Serious Adverse Events (SAEs) |
| Time Frame: | Up to approximately 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of AEs leading to discontinuation |
| Time Frame: | Up to approximately 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of death |
| Time Frame: | Up to approximately 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Hematology tests |
| Time Frame: | Up to approximately 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |
| Time Frame: | Up to approximately 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |
| Time Frame: | Up to approximately 2.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Disease control rate (DCR) assessed by BICR per RECIST v1.1 |
| Time Frame: | Up to 2 years until progression of disease |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response (DOR) assessed by BICR per RECIST v1.1 |
| Time Frame: | Up to 2 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-free survival assessed by BICR per RECIST v1.1 |
| Time Frame: | Up to 2 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
| Measure: | ORR assessed by investigator per RECIST v1.1 |
| Time Frame: | Up to 2 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
| Measure: | DCR assessed by investigator per RECIST v1.1 |
| Time Frame: | Up to 2 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
| Measure: | DOR assessed by investigator per RECIST v1.1 |
| Time Frame: | Up to 2 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
| Measure: | PFS assessed by investigator per RECIST v1.1 |
| Time Frame: | Up to 2 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival (OS) |
| Time Frame: | Up to 3 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
| Measure: | Dose: participant's actual dose as treated |
| Time Frame: | Up to 8 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Response: participant's best overall response (BOR) assessed by BICR using RECIST v1.1 |
| Time Frame: | Up to 2 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
| Measure: | LAG-3 expression by Immunohistochemistry (IHC): participant's actual LAG-3 expression value dichotomized into ≥ 1% and < 1% |
| Time Frame: | Up to 1 month |
| Safety Issue: | |
| Description: | |
| Measure: | Response: participant's BOR assessed by BICR using RECIST v1.1 |
| Time Frame: | Up to 2 years after first dose of treatment |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- Hepatocellular Carcinoma
- Advanced Hepatocellular Carcinoma
- Liver Cancer
- Liver Cancer, Adult
- Liver Cell Carcinoma
- Liver Cell Carcinoma, Adult
Last Updated
July 26, 2021
