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Checkpoint Inhibitor
Subcutaneous Nivolumab + Relatlimab for Melanoma (RELATIVITY-127 Trial)
Phase 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
RELATIVITY-127 Trial Summary
This trial tests if a new drug combo works better than the existing IV treatment for melanoma.
Who is the study for?
This trial is for people aged 12 and older with Stage III (unresectable) or Stage IV (metastatic) melanoma, as per AJCC staging. They must have measurable disease by CT or MRI, be in good physical condition (ECOG ≤1), and adolescents must weigh at least 40 kg. It's not for those with ocular melanoma, a history of myocarditis, or on high-dose steroids/immunosuppressants.Check my eligibility
What is being tested?
The study tests if the subcutaneous form of Nivolumab + Relatlimab combination is as effective as the intravenous version in untreated metastatic/unresectable melanoma patients. The focus is on comparing drug exposure levels between these two methods.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions such as inflammation in various organs, skin issues, hormonal gland problems like thyroid dysfunction, infusion-related reactions similar to allergic responses, fatigue and flu-like symptoms.
RELATIVITY-127 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cavgd28 of Relatlimab
Cminss of Relatlimab
Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab
+1 moreSecondary outcome measures
Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS)
DCR by Investigator per RECIST v1.1
DOR by Investigator per RECIST v1.1
+14 moreRELATIVITY-127 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + Relatlimab FDC SCExperimental Treatment2 Interventions
Group II: Nivolumab + Relatlimab FDC IVActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rHuPH20
2008
Completed Phase 2
~650
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,639 Previous Clinical Trials
4,128,430 Total Patients Enrolled
177 Trials studying Melanoma
56,973 Patients Enrolled for Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have eye melanoma.My melanoma is at Stage III (unresectable) or IV (metastatic).I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am very active or have minor symptoms that don't limit my daily activities.My melanoma is at Stage III (unresectable) or Stage IV (metastatic).My cancer can be measured on scans according to specific criteria.I have never had myocarditis.I am 12 years or older and weigh at least 40 kg if under 18.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab + Relatlimab FDC SC
- Group 2: Nivolumab + Relatlimab FDC IV
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the combination of Nivolumab and Relatlimab FDC SC been approved by the US Food & Drug Administration?
"The safety profile of Nivolumab + Relatlimab FDC SC has been rated a 3 due to the presence of clinical evidence confirming efficacy and multiple studies backing up its security."
Answered by AI
Does this medical research endeavor still accept new participants?
"Clinicaltrials.gov's records indicate that this experiment is no longer recruiting participants, as the trial was first posted on November 30th 2022 and last updated 15 days later. However, patients can still join other medical studies; 756 trials are currently searching for volunteers."
Answered by AI
How many sites are currently involved in the implementation of this research?
"This research project is admitting participants at 10 medical centres, such as those located in Hamilton, Philadelphia and Phoenix. To make the process simpler for patients interested in participating, it's recommended to pick a site near them so they can reduce their travelling needs."
Answered by AI
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