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

Sponsor
University Hospital, Lille
Study ID
NCT02662725
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IPILIMUMAB — DRUG
  • Stereotactic radiosurgery — RADIATION

Study Details

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.

Key Dates

Start date
Sep 30, 2012
Status verified
Jan 2016
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
73 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ipilimumab + Stereotactic Radiosurgery
    ipilimumab combined with a Stereotactic Radiosurgery in Melanoma Patients with Brain Metastases

Primary Outcome Measure

Overall survival rate [ Time Frame: until week 96 or death ]

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