What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for melanoma, such as Nivolumab (a PD-1 inhibitor) and its combinations, are associated with several side effects. The most frequently reported adverse events include skin reactions (e.g., rash, pruritus), endocrine disorders (e.g., hypothyroidism, adrenal insufficiency), and gastrointestinal issues (e.g., diarrhea, colitis). When combined with other agents like Ipilimumab, the incidence of severe side effects, such as pneumonitis, hepatitis, and nephritis, can increase. These treatments can also lead to immune-related adverse events that may require immunosuppressive therapy for management.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of melanoma, particularly those targeting immune checkpoints. Nivolumab, a PD-1 inhibitor, has been approved for use both as a monotherapy and in combination with Ipilimumab, a CTLA-4 inhibitor, for advanced melanoma. Pembrolizumab, another PD-1 inhibitor, is also approved for melanoma treatment. These therapies work by enhancing the body's immune response against cancer cells. The combination of Nivolumab and Relatlimab, which targets both PD-1 and LAG-3 pathways, represents a novel approach in this category, aiming to further improve immune system activation against melanoma.

What other types of research exist?

Promising alternatives to Nivolumab + Relatlimab for melanoma patients include: 1) Ipilimumab (CTLA-4 Inhibitor) combined with Nivolumab, which has shown activity in various cancers including melanoma. 2) Pembrolizumab (PD-1 Inhibitor) combined with other agents like Talimogene Laherparepvec (T-VEC), which has shown efficacy in advanced melanoma. 3) Emerging therapies targeting other immune checkpoints such as TIGIT or TIM-3, which are currently under investigation and may offer new treatment options in the near future.

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Subcutaneous vs Intravenous Nivolumab + Relatlimab for Melanoma

Phase 2

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

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:

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I am not currently taking steroids for inflammation or drugs that weaken my immune system.

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I do not have cancer in my eyes or mucous membranes.

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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

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.

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

~5250

0 / 3Eligibility criteria met

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.