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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hepatoma, Hepatocellular Carcinoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult

Intervention / Treatment
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* Biological: Nivolumab
* Biological: Relatlimab


Participation Criteria
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Eligibility Criteria
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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 in the advanced/metastatic setting 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 Have received one or two lines of tyrosine kinase inhibitor therapies Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A : Nivolumab<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: OPDIVO, BMS-936558;|
| Experimental: Arm B : Nivolumab + Relatlimab Dose 1<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: OPDIVO, BMS-936558;Biological: Relatlimab<br>* Specified dose on specified days<br>* Other names: BMS-986016;|
| Experimental: Arm C : Nivolumab + Relatlimab Dose 2<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: OPDIVO, BMS-936558;Biological: Relatlimab<br>* Specified dose on specified days<br>* Other names: BMS-986016;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |  | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to approximately 2.5 years | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to approximately 2.5 years | 
| Incidence of AEs leading to discontinuation |  | Up to approximately 2.5 years | 
| Incidence of death |  | Up to approximately 2.5 years | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to approximately 2.5 years | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |  | Up to approximately 2.5 years | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to approximately 2.5 years | 
| Disease control rate (DCR) assessed by BICR per RECIST v1.1 |  | Up to 2 years until progression of disease | 
| Duration of response (DOR) assessed by BICR per RECIST v1.1 |  | Up to 2 years after first dose of treatment | 
| Progression-free survival assessed by BICR per RECIST v1.1 |  | Up to 2 years after first dose of treatment | 
| ORR assessed by investigator per RECIST v1.1 |  | Up to 2 years after first dose of treatment | 
| DCR assessed by investigator per RECIST v1.1 |  | Up to 2 years after first dose of treatment | 
| DOR assessed by investigator per RECIST v1.1 |  | Up to 2 years after first dose of treatment | 
| PFS assessed by investigator per RECIST v1.1 |  | Up to 2 years after first dose of treatment | 
| Overall survival (OS) |  | Up to 3 years after first dose of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cell Carcinoma, Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Liver Cancer, Adult, Liver Cell Carcinoma, Adult