At a glance
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GM-CSF and Ipilimumab as Therapy in Metastatic Melanoma, a Phase II Study
In Brief
A Phase 2 clinical trial evaluating Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Ipilimumab for Malignant Melanoma, Metastatic. Completed, enrolled 29 participants across 2 sites.
Detailed Summary
The study is an open-label, single arm single Center Phase II study to evaluate the safety and efficacy of the combination of Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF, Leukine) and Ipilimumab (Yervoy) as therapy for patients with unresectable metastatic malignant melanoma.
Study Details
Timeline
Interventions
GM-CSF will be administered subcutaneously daily for 14 days in a dose of 125 µg/m2 beginning on D1 of each 21-day cycle for 8 cycles until month 6. Maintenance therapy will begin at month 6 and will consist 14 days of GM-CSF repeated every 3 months for up to 2 years or until disease progression, whichever occurs first.
Patients will be treated with 4 courses of ipilimumab administered every 3 weeks intravenously in a dose of 10 mg/kg, with appropriate stopping/de-escalation rules. Maintenance therapy will begin at month 6 and will consist of ipilimumab in the same dose administered at the end of cycle 4 repeated every 3 months for up to 2 years or until disease progression, whichever occurs first.