Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
This is a non-controlled, open label, Phase II Study of ipilimumab combined with a
Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of
Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3
days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10
mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity
or withdrawal of consent or disease progression. The primary objective is the overall
survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute
lymphocyte count (ALC) as a predictive biomarker.