OncoMatch/Clinical Trials/NCT05704647
Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
Is NCT05704647 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BMS-986213 (Relatlimab-Nivolumab FDC) and Nivolumab for melanoma (skin).
Treatment: BMS-986213 (Relatlimab-Nivolumab FDC) · Nivolumab · Relatlimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: checkpoint inhibitor
Exception: Patients who received ipilimumab and/or anti-PD1 as adjuvant or neoadjuvant therapy must have a 6-month washout before receiving any dosing on this study.
Prior checkpoint inhibitor therapy in the metastatic setting
Cannot have received: stereotactic or highly conformal radiotherapy
Exception: Allowed if >1 week before start of dosing and field did not include brain index lesion(s)
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).
Cannot have received: whole brain radiation
Prior whole brain radiation is not allowed.
Cannot have received: stereotactic radiotherapy to >5 brain lesions
Subjects previously treated with SRT > 5 lesions in the brain.
Cannot have received: investigational drug
Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of nivolumab and relatlimab.
Lab requirements
Blood counts
Adequate organ function as described below.
Kidney function
Adequate organ function as described below.
Liver function
Adequate organ function as described below.
Cardiac function
No history of clinically significant cardiac disease or congestive heart failure > NYHA class 2. No unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months or a history of myocarditis. Troponin T (TnT) or I (TnI) > 2 × institutional ULN excluded.
Adequate organ function as described below. History of clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2. Troponin T (TnT) or I (TnI) > 2 × institutional ULN excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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