Pilot Ipilimumab in Stage IV Melanoma Receiving Palliative Radiation Therapy

Conditions

Ipilimumab — DRUG
Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
Radiation Therapy — RADIATION
Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist.

To determine the safety of local palliative radiation therapy used in combination with anti-CTLA-4 immunotherapy.

Experimental: Ipilimumab Treatment + Radiation Therapy
Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1 to 2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2 to 4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.

Safety Measurement - Percentage of Patients Experiencing Serious Adverse Events (SAEs) in the First 4 Months of Treatment. [ Time Frame: 4 months ]

Facility	City	State	ZIP	Site coordinators
Stanford University School of Medicine	Stanford	California	94305	-

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