Spots Global Cancer Trial Database for Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases

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Trial Identification

Brief Title: Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases

Official Title: A Multicenter Phase II Study of Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases

Study ID: NCT02662725

Conditions

Melanoma

Brain Metastasis

Interventions

IPILIMUMAB

Stereotactic radiosurgery

Study Description

Brief 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.

Detailed Description: