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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
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 below
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had myocarditis in the past.
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I do not have any serious or uncontrolled medical conditions.
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I have an autoimmune disease.
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I have had a COVID-19 infection within the last 4 weeks.
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I have never received immunotherapy for any cancer.
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I have had eye melanoma in the past.
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I have brain or spinal cord metastases that haven't been treated or removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
2,682 Previous Clinical Trials
4,128,519 Total Patients Enrolled
179 Trials studying Melanoma
56,665 Patients Enrolled for Melanoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05002569 — Phase 3
Melanoma Research Study Groups: Arm A: Nivolumab Plus Relatlimab, Arm B: Nivolumab
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05002569 — Phase 3
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05002569 — Phase 3
~288 spots leftby Feb 2026
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