Nivolumab for Carcinoma, Hepatocellular

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Local Institution - 0038, Pamplona, Spain
Carcinoma, Hepatocellular+1 More
Nivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

Eligible Conditions

  • Carcinoma, Hepatocellular

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Hepatocellular

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Assessed up to 3 years

Year 3
ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive
OS of all randomized participants that are LAG-3 positive
Objective response rate (ORR) by BICR per RECIST v1.1 in all randomized participants
Overall Survival (OS) of all randomized participants
PFS by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive
Progression-free survival (PFS) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized participants
Day 135
Number of participants with adverse events (AEs)
Up to 6 weeks
Incidence of dose-limiting toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

Other trials for Carcinoma, Hepatocellular

Trial Design

2 Treatment Groups

Arm B: Placebo + Nivolumab + Bevacizumab
1 of 2
Arm A: Relatlimab + Nivolumab + Bevacizumab
1 of 2
Experimental Treatment

162 Total Participants · 2 Treatment Groups

Primary Treatment: Nivolumab · Has Placebo Group · Phase 1 & 2

Arm B: Placebo + Nivolumab + BevacizumabExperimental Group · 3 Interventions: Bevacizumab, Placebo, Nivolumab · Intervention Types: Drug, Other, Drug
Arm A: Relatlimab + Nivolumab + BevacizumabExperimental Group · 3 Interventions: Relatlimab, Bevacizumab, Nivolumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2014
Completed Phase 4
~4030
Nivolumab
2014
Completed Phase 3
~5540

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed up to 3 years
Closest Location: Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center · Baltimore, MD
Photo of Baltimore 1Photo of Baltimore 2Photo of Baltimore 3
2017First Recorded Clinical Trial
1 TrialsResearching Carcinoma, Hepatocellular
1 CompletedClinical Trials

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,463 Previous Clinical Trials
3,907,742 Total Patients Enrolled
32 Trials studying Carcinoma, Hepatocellular
7,906 Patients Enrolled for Carcinoma, Hepatocellular

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You have histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.