Nivolumab alone or with ipilimumab produces durable, clinical responses among patients with previously untreated brain metastases from primary melanoma, according to a study published in The Lancet Oncology.1

Previous studies demonstrated that immunotherapy and targeted therapies prolong the overall survival (OS) among patients with melanoma, though the benefits for those with brain metastases require further study.

For this phase 2 study ( Identifier: NCT02374242), researchers randomly assigned 79 patients with immunotherapy-naive melanoma with brain metastases to 1 of 3 cohorts: intravenous (IV) nivolumab 1 mg/kg plus IV ipilimumab 3 mg/kg (Cohort A), IV nivolumab 3 mg/kg alone (Cohort B), or a cohort for patients brain metastases who had failed local therapy, had neurological symptoms, or had leptomeningeal disease (IV nivolumab 3mg/kg alone [Cohort C]).

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Thirty-five, 26, and 16 patients enrolled into Cohorts A, B, and C were evaluable at the time of analysis.

After a median follow-up of 17 months, 46% (16) of patients in Cohort A achieved intracranial response compared with 20% (5) in Cohort B and 6% (1) in Cohort C.

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Intracranial complete responses (CR) occurred among 17% (6) and 12% (3) of patients in Cohorts A and B, respectively. No patients in Cohort C had an intracranial CR.

Grade 3 to 4 adverse events were observed in 54% (19), 16% (4), and 13% (2) of patients in Cohorts A, B, and C, respectively, including diarrhea, colitis, hepatitis, and pulmonary edema. No treatment-related deaths were reported.

The authors concluded that “nivolumab combined with ipilimumab should be considered as a first-line therapy for patients with asymptomatic untreated brain metastases.”


  1. Long GV, Atkinson V, Lo S, et al. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol. 2018 Mar 27. doi: 10.1016/S1470-2045(18)30139-6 [Epub ahead of print]