RecruitingPhase 2NCT06712927

Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases

A Multicenter, Phase II Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases


Sponsor

Stanford University

Enrollment

60 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a triple immunotherapy combination — relatlimab, nivolumab, and ipilimumab — in patients with melanoma that has spread to the brain, aiming to see if targeting three different immune checkpoints together is more effective than existing options. **You may be eligible if...** - You are 18 or older with confirmed melanoma (not uveal/eye type) that has spread to the brain - You have at least one untreated, measurable brain tumor between 5–40 mm - You have not received prior immunotherapy targeting CTLA-4, PD-1, or LAG-3 for advanced melanoma - You are in good general health (ECOG 0–1 for asymptomatic; 0–2 for symptomatic group) **You may NOT be eligible if...** - You have uveal (eye) melanoma - All brain tumors have been previously treated with radiation or surgery - You have received prior immune checkpoint therapy for unresectable or advanced melanoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIpilimumab

1 mg/kg of Ipilimumab will be administered via IV every 8 weeks. Participants will be assigned to Cohort A or B as per eligibility criteria. No randomization or blinding will occur

DRUGNivolumab + Relatlimab FDC

Relatlimab 160mg + Nivo 480mg will be administered via IV every 4 weeks. Participants will be assigned to Cohort A or B as per eligibility criteria. No randomization or blinding will occur


Locations(1)

Stanford University

Palo Alto, California, United States

View Full Details on ClinicalTrials.gov

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NCT06712927


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