GM-CSF and Ipilimumab as Therapy in Metastatic Melanoma, a Phase II Study
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. The patient sample will be approximately 43 evaluable individuals, males
and females 18 years of age or older with measurable metastatic melanoma. Immunologic
testing will be done to evaluate correlation with clinical outcome.
Patients will be treated with 4 courses of GM-CSF and ipilimumab administered every 3 weeks.
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. Ipilimumab intravenously in a dose of 10 mg/kg, with
appropriate stopping/de-escalation rules. After the initial 3 months (4 cycles) of
treatment, GM-CSF administration will continue for 4 additional cycles on the same schedule
and dose without ipilimumab for 14 days every 21 days until month 6. Maintenance therapy
will begin at month 6 and will consist of ipilimumab in the same dose administered at the
end of cycle 4 combined with 14 days of GM-CSF. Administration of this combination will be
repeated every 3 months for up to 2 years or until disease progression, whichever occurs
first. During the maintenance phase, GM-CSF will only be administered for 14 days in
conjunction with ipilimumab and will not be administered in the intervening time period.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease control rate at 24 weeks as defined by the immune-related Response Criteria (irRC)
Disease control rate will be measured at 24 weeks from the start date of protocol therapy using the immune-related Response Criteria (irRC)
Lynn E. Spitler, M.D.
Northern California Melanoma Center, St. Mary's Medical Center
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|
|Northern Californai Melanoma Center, St. Mary's Medical Center||San Francisco, California 94117|