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.
Age ≥ 18 years old.
Life Expectancy > 12 weeks.
Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
Histologically confirmed malignant melanoma with measurable metastases in the brain (≥ 0.5 cm).
History of known leptomeningeal involvement (lumbar puncture not required).
Previous stereotactic or highly conformal radiotherapy within 1 weeks before the start of dosing for this study. NOTE: The stereotactic radiotherapy field must not have included the brain index lesion(s).
Subjects previously treated with SRT > 5 lesions in the brain. Prior whole brain radiation is not allowed.
Brain lesion size > 3 cm.
Single group
BMS-986213 (Relatlimab-Nivolumab FDC)
DrugGiven by IV (vein)
Nivolumab
DrugGiven by IV (vein)
Relatlimab
DrugGiven by IV (vein)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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