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)

Bristol-Myers Squibb127 sites in 15 countries266 target enrollmentFebruary 4, 2021

ConditionsHepatocellular Carcinoma Hepatoma Liver Cancer, Adult Liver Cell Carcinoma Liver Cell Carcinoma, Adult

InterventionsNivolumab Relatlimab

DrugsNivolumab Relatlimab

Overview

Phase: Phase 2
Intervention: Nivolumab
Conditions: Hepatocellular Carcinoma
Sponsor: Bristol-Myers Squibb
Enrollment: 266
Locations: 127
Primary Endpoint: Objective Response Rate(ORR) Assessed by BICR
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 4, 2021

End Date

November 19, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Arm A : Nivolumab

Intervention: Nivolumab

Arm B : Nivolumab + Relatlimab Dose 1

Intervention: Nivolumab

Arm B : Nivolumab + Relatlimab Dose 1

Intervention: Relatlimab

Arm C : Nivolumab + Relatlimab Dose 2

Intervention: Nivolumab

Arm C : Nivolumab + Relatlimab Dose 2

Intervention: Relatlimab

Outcomes

Primary Outcomes

Objective Response Rate(ORR) Assessed by BICR

Time Frame: From randomization to primary completion date (Approximately 29.5 Months)

Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.

Secondary Outcomes

Disease Control Rate Assessed by BICR(From randomization to primary completion date (Approximately 29.5 Months))
Duration of Response Assessed by BICR(From randomization to primary completion date (Approximately 29.5 Months))
Progression Free Survival(PFS) Assessed by BICR(From randomization to primary completion date (Approximately 29.5 Months))
Objective Response Rate Assessed by Investigator(From randomization to primary completion date (Approximately 29.5 Months))
Disease Control Rate Assessed by Investigator(From randomization to primary completion date (Approximately 29.5 Months))
Duration of Response Assessed by Investigator(From randomization to primary completion date (Approximately 29.5 Months))
Progression Free Survival(PFS) Assessed by Investigator(From randomization to primary completion date (Approximately 29.5 Months))
Overall Survival (OS)(From randomization to primary completion date (Approximately 29.5 Months))
Number of Participants With Adverse Events(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)
Number of Participants With Serious Adverse Events(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)
Number of Participants With Adverse Events Leading to Discontinuation(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)
Death Summary(From randomization to primary completion date (Approximately 29.5 Months))
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)
Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)