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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 90 months
Awards & highlights
RELATIVITY-098 Trial 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.Check my eligibility
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.See study design
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.
RELATIVITY-098 Trial 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.
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I can provide a sample of my tumor for testing.
Select...
I am 18 or older and can do all my own self-care.
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I've been confirmed disease-free by a recent physical exam and imaging.
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I was diagnosed with Stage IIIA/B/C/D or IV melanoma and had surgery to remove it completely.
RELATIVITY-098 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 90 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 90 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-Free Survival (RFS) time per Investigator assessment
Secondary outcome measures
Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
Incidence of AEs leading to discontinuation (DC)
Incidence of Adverse Events (AEs)
+13 moreRELATIVITY-098 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
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,129,782 Total Patients Enrolled
177 Trials studying Melanoma
56,344 Patients Enrolled for Melanoma
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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.
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