Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Nivolumab + Relatlimab for Melanoma (RELATIVITY-098 Trial)
Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
Tumor tissue must be provided for biomarker analyses
Must not have
History of myocarditis, regardless of etiology
Participants with serious or uncontrolled medical disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will compare nivolumab + relatlimab to nivolumab alone to see if the combo is more effective in treating melanoma.
Who is the study for?
Adults and adolescents with completely removed stage III-IV melanoma can join this trial. They must be in good physical condition, not have had prior immunotherapy, or any serious medical issues. People with eye melanoma, brain metastases, recent COVID-19 infection, heart inflammation history, or autoimmune diseases cannot participate.
What is being tested?
The study is testing the effectiveness of combining two drugs (Nivolumab + Relatlimab) versus using Nivolumab alone as a follow-up treatment to prevent melanoma from coming back after surgery.
What are the potential side effects?
Possible side effects include immune-related reactions affecting various organs like the liver or lungs, skin rash, hormone gland problems (like thyroid), infusion reactions during drug administration and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a teenager and can do most activities without help.
Select...
I can provide a sample of my tumor for testing.
Select...
I am 18 or older and can do all my own self-care.
Select...
I've been confirmed disease-free by a recent physical exam and imaging.
Select...
I was diagnosed with Stage IIIA/B/C/D or IV melanoma and had surgery to remove it completely.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had myocarditis in the past.
Select...
I do not have any serious or uncontrolled medical conditions.
Select...
I have an autoimmune disease.
Select...
I have had a COVID-19 infection within the last 4 weeks.
Select...
I have never received immunotherapy for any cancer.
Select...
I have had eye melanoma in the past.
Select...
I have brain or spinal cord metastases that haven't been treated or removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: NivolumabExperimental Treatment1 Intervention
Monotherapy
Group II: Arm A: Nivolumab Plus RelatlimabExperimental Treatment1 Intervention
Combination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,021 Total Patients Enrolled
179 Trials studying Melanoma
56,640 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a teenager and can do most activities without help.I have had myocarditis in the past.I can provide a sample of my tumor for testing.I do not have any serious or uncontrolled medical conditions.I have an autoimmune disease.I have had a COVID-19 infection within the last 4 weeks.I am 18 or older and can do all my own self-care.I have never received immunotherapy for any cancer.I've been confirmed disease-free by a recent physical exam and imaging.I was diagnosed with Stage IIIA/B/C/D or IV melanoma and had surgery to remove it completely.I had surgery to remove my tumor completely within the last 3 months.I have had eye melanoma in the past.I have brain or spinal cord metastases that haven't been treated or removed.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Nivolumab Plus Relatlimab
- Group 2: Arm B: Nivolumab
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.