What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly those involving immune checkpoint inhibitors like Nivolumab (a PD-1 inhibitor) and Ipilimumab (a CTLA-4 inhibitor), are associated with a range of immune-related adverse events. These can include skin reactions such as rash and pruritus, endocrine issues like thyroid dysfunction, and gastrointestinal problems such as diarrhea and colitis. More severe side effects can involve pneumonitis, hepatitis, and nephritis. Combination therapies, such as Nivolumab and Ipilimumab, tend to have higher rates of severe side effects compared to single-agent treatments.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of melanoma. Nivolumab (Opdivo) and Pembrolizumab (Keytruda) are PD-1 inhibitors that have shown significant efficacy in treating advanced melanoma. Additionally, the combination of Nivolumab and Ipilimumab (a CTLA-4 inhibitor) has been approved for enhanced efficacy in melanoma patients. While specific FDA approvals for LAG-3 inhibitors like Relatlimab are not detailed, the combination of PD-1 inhibitors with other immune checkpoint inhibitors represents a promising approach in melanoma treatment.

What other types of research exist?

Promising alternatives to Nivolumab + Relatlimab for melanoma patients include: 1) Pembrolizumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown efficacy in various trials. 2) Atezolizumab (PD-L1 inhibitor) combined with Cobimetinib (MEK inhibitor), which targets different pathways. 3) Emerging therapies targeting TIM-3, TIGIT, and VISTA, which are currently being evaluated in clinical trials and may offer new avenues for treatment.

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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 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two ways of giving a combination of two drugs, nivolumab and relatlimab, to patients with advanced melanoma that hasn't been treated before. One method involves injecting the drugs under the skin, while the other involves injecting them into a vein. These drugs help the immune system recognize and attack cancer cells.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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.

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

2019

Completed Phase 2

~920

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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

The most common treatments for melanoma, particularly advanced cases, involve immune checkpoint inhibitors such as Nivolumab (a PD-1 inhibitor) and Relatlimab (a LAG-3 inhibitor). These drugs work by blocking proteins that prevent the immune system from attacking melanoma cells. Nivolumab inhibits the PD-1 protein on T-cells, enhancing their ability to detect and destroy cancer cells. Relatlimab targets LAG-3, another inhibitory protein on T-cells, further boosting the immune response. This dual inhibition is significant for melanoma patients as it can lead to more effective and sustained anti-tumor activity, potentially improving survival rates and outcomes.