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Subcutaneous vs Intravenous Nivolumab + Relatlimab for Melanoma
Phase 2
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
Be older than 18 years old
Must not have
Must not have any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)
Must not have any cancer in the eyes or mucous membranes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two injection methods for cancer treatment to see which one patients prefer and to ensure they are safe. The treatments help the immune system attack cancer cells.
Who is the study for?
This trial is for adults with melanoma, either metastatic without prior treatment or resected and confirmed disease-free within the last 12 weeks. Participants should have low disability and be at intermediate to advanced risk. Those with brain cancer treated by radiation, eye/mucous membrane cancers, autoimmune diseases, or on steroids/immunosuppressants cannot join.
What is being tested?
The study evaluates patient preference between subcutaneous (under the skin) injections versus intravenous (into a vein) administration of Nivolumab alone or combined with Relatlimab. It also examines safety related to switching from IV to SC delivery.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the lungs or intestines, infusion-related symptoms such as fever or chills, fatigue, skin issues like rash, and potential increased infection risk.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently taking steroids for inflammation or drugs that weaken my immune system.
Select...
I do not have cancer in my eyes or mucous membranes.
Select...
I have not had radiation treatment for brain cancer/disease.
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
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: Cohort 2: Resected MelanomaExperimental Treatment2 Interventions
Group II: Cohort 1: Metastatic MelanomaExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~6290
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for melanoma, such as nivolumab (a PD-1 inhibitor) and relatlimab (a LAG-3 inhibitor), work by blocking immune checkpoints that typically suppress the immune system's ability to attack cancer cells. Nivolumab inhibits the PD-1 pathway, while relatlimab targets the LAG-3 pathway.
By blocking these pathways, these drugs reactivate T-cells, enhancing the immune system's ability to recognize and destroy melanoma cells. This mechanism is vital for melanoma patients as it leverages the body's natural defenses to fight cancer more effectively, potentially improving survival rates and treatment outcomes.
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,971 Total Patients Enrolled
179 Trials studying Melanoma
57,590 Patients Enrolled for Melanoma