RecruitingPhase 2NCT05704647

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases


Sponsor

M.D. Anderson Cancer Center

Enrollment

30 participants

Start Date

Feb 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — nivolumab and relatlimab — in patients with melanoma (skin cancer) that has spread to the brain and has not yet been treated with local brain therapy such as radiation or surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with melanoma that has confirmed metastases in the brain - At least one brain tumor is 0.5 cm to 3 cm in size and has not received prior radiation - You are in reasonably good health with a life expectancy of more than 12 weeks - You are willing to provide tumor tissue for testing **You may NOT be eligible if...** - All your brain metastases have already been treated with radiation or surgery - You have active autoimmune disease requiring systemic treatment - You have had prior treatment with other checkpoint inhibitor combinations that included LAG-3 or PD-1 targeting - You are pregnant or breastfeeding 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

DRUGBMS-986213 (Relatlimab-Nivolumab FDC)

Given by IV (vein)

DRUGNivolumab

Given by IV (vein)

DRUGRelatlimab

Given by IV (vein)


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05704647


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