Ipilimumab in a Phase II trial of melanoma patients with brain metastases

In a Phase II clinical study enrolling individuals with melanoma brain metastases, 51 asymptomatic patients (cohort A) and 21 on a stable steroid dose (cohort B) received 4 courses of 10 mg/kg intravenous ipilimumab (induction), then (at 24 weeks) maintenance therapy with the same dose of ipilimumab every 12 weeks. Disease control rate at 12 weeks was 18% (according to the modified WHO criteria) and 26% (according to the immune-related response criteria) in cohort A (median survival = 7 mo) and 5% and 10% in cohort B (median survival = 4 mo). Toxicities were as previously reported for ipilimumab patients without brain metastases.