Nivolumab + Relatlimab Fixed Dose Combination for Melanoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Melanoma
Nivolumab + Relatlimab Fixed Dose Combination - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare nivolumab + relatlimab to nivolumab alone to see if the combo is more effective in treating melanoma.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Melanoma

Study Objectives

1 Primary · 17 Secondary · Reporting Duration: Until second recurrence, up to 5 years

Day 135
Incidence of immune-mediated AEs (IMAEs)
Severity of IMAEs
Day 30
Incidence of AEs leading to discontinuation (DC)
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Incidence of deaths
Incidence of drug related AEs
Severity of AEs
Severity of AEs leading to DC
Severity of SAEs
Severity of drug related AEs
Month 96
Overall Survival (OS)
Month 96
Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
Year 5
Duration of Treatment on next line therapies
Month 59
Recurrence-Free Survival (RFS) time per Investigator assessment
Year 5
Progression-Free Survival 2 (PFS2)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Melanoma

Trial Design

3 Treatment Groups

Arm B: Nivolumab
1 of 3
Arm A: Nivolumab Plus Relatlimab
1 of 3
Arm A: Relatlimab + Nivolumab
1 of 3
Experimental Treatment

1050 Total Participants · 3 Treatment Groups

Primary Treatment: Nivolumab + Relatlimab Fixed Dose Combination · No Placebo Group · Phase 3

Arm B: Nivolumab
Biological
Experimental Group · 1 Intervention: Nivolumab · Intervention Types: Biological
Arm A: Nivolumab Plus Relatlimab
Biological
Experimental Group · 1 Intervention: Nivolumab + Relatlimab Fixed Dose Combination · Intervention Types: Biological
Arm A: Relatlimab + NivolumabExperimental Group · 3 Interventions: Relatlimab + Nivolumab Fixed Dose Combination, Relatlimab, Nivolumab · Intervention Types: Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relatlimab
Not yet FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until second recurrence, up to 5 years

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,481 Previous Clinical Trials
3,918,542 Total Patients Enrolled
174 Trials studying Melanoma
57,145 Patients Enrolled for Melanoma

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a melanoma that is surgically resected (free of disease) with negative margins.
You are eligible for the study if you have complete resection of your tumor within 90 days prior to randomization.
You must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization.
Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 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.

Who else is applying?

What state do they live in?
Texas50.0%
Oregon50.0%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
Local Institution50.0%
University of Texas MD Anderson Cancer Center-Melanoma Medical Oncology50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%