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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

Primary Purpose

Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Relatlimab

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Local Institution - 0010
Local Institution - 0019
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Local Institution - 0063
Oncologia de Preciso e Personalizada
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica
Unidade de Pesquisa Clínica do Hospital da Clínicas de Ribeirão Preto-Clinical Oncology
Local Institution - 0015
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Local Institution - 0101
Local Institution - 0100
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Local Institution - 0003
Local Institution - 0013
Local Institution - 0012
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Local Institution - 0039
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Local Institution - 0070
Local Institution - 0001
Local Institution - 0004
Local Institution - 0050
Local Institution - 0066
Local Institution - 0073
Local Institution - 0051
Local Institution - 0049
Local Institution - 0058
Local Institution - 0041
Local Institution - 0034
Local Institution - 0031
Local Institution - 0042
Local Institution - 0032
Local Institution - 0089
Local Institution - 0090
Local Institution - 0091

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm A : Nivolumab

Arm B : Nivolumab + Relatlimab Dose 1

Arm C : Nivolumab + Relatlimab Dose 2

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

Incidence of Adverse Events (AEs)

Incidence of Serious Adverse Events (SAEs)

Incidence of AEs leading to discontinuation

Incidence of death

Incidence of clinically significant changes in clinical laboratory results: Hematology tests

Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Disease control rate (DCR) assessed by BICR per RECIST v1.1

Duration of response (DOR) assessed by BICR per RECIST v1.1

Progression-free survival assessed by BICR per RECIST v1.1

ORR assessed by investigator per RECIST v1.1

DCR assessed by investigator per RECIST v1.1

DOR assessed by investigator per RECIST v1.1

PFS assessed by investigator per RECIST v1.1

Overall survival (OS)

Full Information

NCT ID

NCT04567615

First Posted

September 24, 2020

Last Updated

September 28, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT04567615

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 4, 2021 (Actual)

Primary Completion Date

August 31, 2023 (Actual)

Study Completion Date

January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

266 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A : Nivolumab

Arm Type

Experimental

Arm Title

Arm B : Nivolumab + Relatlimab Dose 1

Arm Type

Experimental

Arm Title

Arm C : Nivolumab + Relatlimab Dose 2

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

OPDIVO, BMS-936558

Intervention Description

Specified dose on specified days

Intervention Type

Biological

Intervention Name(s)

Relatlimab

Other Intervention Name(s)

BMS-986016

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Incidence of Adverse Events (AEs)

Time Frame

Up to approximately 2.5 years

Title

Incidence of Serious Adverse Events (SAEs)

Time Frame

Up to approximately 2.5 years

Title

Incidence of AEs leading to discontinuation

Time Frame

Up to approximately 2.5 years

Title

Incidence of death

Time Frame

Up to approximately 2.5 years

Title

Incidence of clinically significant changes in clinical laboratory results: Hematology tests

Time Frame

Up to approximately 2.5 years

Title

Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

Time Frame

Up to approximately 2.5 years

Title

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Time Frame

Up to approximately 2.5 years

Title

Disease control rate (DCR) assessed by BICR per RECIST v1.1

Time Frame

Up to 2 years until progression of disease

Title

Duration of response (DOR) assessed by BICR per RECIST v1.1

Time Frame