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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 (Jun 2026). This Phase 2 trial studies multiple treatments including BMS-986213 (Relatlimab-Nivolumab FDC) and Nivolumab for melanoma (skin).

Phase 2RecruitingM.D. Anderson Cancer CenterNCT05704647Data as of Jun 2026

Treatment: BMS-986213 (Relatlimab-Nivolumab FDC) · Nivolumab · RelatlimabTo 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

BMS-986213 (Relatlimab-Nivolumab FDC)NivolumabRelatlimab

Cancer type

Melanoma

Biomarker criteria

Required: PD-L1 (CD274) expression (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 in the metastatic setting

Exception: adjuvant/neoadjuvant ipilimumab and/or anti-PD1 allowed if ≥6 months washout

Prior checkpoint inhibitor therapy in the metastatic setting. 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.

Cannot have received: whole brain radiation

Prior whole brain radiation is not allowed

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.

Adequate organ function as described below.

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 →

Frequently asked questions

Is NCT05704647 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior checkpoint inhibitor in the metastatic setting, whole brain radiation disqualifies patients from enrollment.

Does this trial require CD274?

Yes, CD274 expression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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