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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 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.

RELATIVITY-098 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 90 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 90 months for reporting.

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 more

RELATIVITY-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
2,638 Previous Clinical Trials
4,127,464 Total Patients Enrolled
177 Trials studying Melanoma
56,493 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are there in total?

"The sponsor, Bristol-Myers Squibb, needs to enroll 1050 patients that meet the clinical trial's inclusion criteria . The study will take place at University Of Colorado in Atlanta, Georgia and Emory University Hospital in Aurora, Colorado."

Answered by AI

Are new patients being accepted into this research project?

"That is correct. The information provided on clinicaltrials.gov indicates that the trial is looking for 1050 individuals at 88 sites."

Answered by AI

How does the Nivolumab + Relatlimab Fixed Dose Combination affect patients long-term?

"Nivolumab + Relatlimab Fixed Dose Combination is estimated to be a 3 on Power's 1-3 scale."

Answered by AI

Why is Nivolumab + Relatlimab Fixed Dose Combination commonly prescribed?

"Nivolumab + Relatlimab Fixed Dose Combination is most commonly used as a treatment for malignant neoplasms; however, it can also be effective in treating metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma."

Answered by AI

Has this sort of treatment been done before?

"Nivolumab + Relatlimab Fixed Dose Combination has undergone clinical study since 2010. Medarex first sponsored a 127-person Phase 1 trial in 2010, which ultimately led to the drug's approval. In the present day, there are 749 active trials for Nivolumab + Relatlimab Fixed Dose Combination being conducted across 2348 cities and 50 countries."

Answered by AI

At how many different geographical locations is this trial being conducted?

"Across 88 different enrolment locations, this trial currently has University Of Colorado in Atlanta, Emory University Hospital in Aurora, and Sacred Heart Medical Group in Pensacola as participants."

Answered by AI

Are there other instances where Nivolumab and Relatlimab have been studied together?

"The Nivolumab + Relatlimab Fixed Dose Combination was first examined in 2010 at the H. Lee Moffitt Cancer Center and Research Institute. There have been 249 completed trials since then, with 749 more ongoing as of now. Many of these are based out of Atlanta, Georgia."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Oregon
How old are they?
65+
18 - 65
What site did they apply to?
Local Institution
University of Texas MD Anderson Cancer Center-Melanoma Medical Oncology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
2021. "A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05002569.
~432 spots leftby Feb 2026
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