CURRENTLY ACTIVE CLINICAL TRIALS

July 2011

GM-CSF and Ipilimumab as Therapy in Metastatic Melanoma, a Phase II Study

This is an open-label non-randomized trial in which patients will be treated with an induction regimen of ipilimumab (Yervoy, 4 21-day cycles at 10 mg/kg) with GM-CSF (Leukine) followed by 4 additional cycles of GM-CSF alone.  This will be followed by a maintenance regimen of ipilimumab and GM-CSF administered every 3 months up to total treatment duration of 2 years.  For more information clinicaltrials.gov, NCT01363206.

Inclusion Criteria:

1. Histologically confirmed, (surgically incurable or unresectable) stage III or IV metastatic malignant melanoma. 
   
   
2. Prior systemic therapy for metastatic disease is permitted but not required.  Adequate hematologic, renal and liver function.
   
   
3. LDH ≤ 4 times upper limit of laboratory normal. 
   
   
4. Patients with brain metastases that have been treated and stable for at least 1 month are eligible.

Exclusion Criteria: 

1. Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s Granulomatosis), motor neuropathy considered of autoimmune origin (e.g. Guillain-Barré Syndrome).

Current Therapies >>