NCT02662725

Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Brain Metastasis

Interventions

Type	Name	Description
DRUG	IPILIMUMAB
RADIATION	Stereotactic radiosurgery

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-01-25
• Last updated: 2016-01-25

Locations

18 sites across 1 country: France