Liver Metastases Clinical Trial
Official title:
Pilot Study of Sequential Hepatic Radioembolization and Systemic Ipilimumab in Patients With Uveal Melanoma Metastatic to Liver
This pilot clinical trial studies radioembolization and ipilimumab in treating patients with uveal melanoma with liver metastases. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radioembolization together with ipilimumab may kill more tumor cells in patients with uveal melanoma
PRIMARY OBJECTIVE:
I. To estimate the safety and efficacy of sequential hepatic radioembolization and systemic
ipilimumab in patients with uveal melanoma metastatic to liver.
SECONDARY OBJECTIVES:
I. To evaluate effects on regulators of tumor immunity.
OUTLINE:
Patients undergo radioembolization with yttrium Y 90 glass microspheres via hepatic arterial
infusion on day 1. Beginning on day 29, patients also receive ipilimumab intravenously (IV)
over 90 minutes. Treatment with ipilimumab repeats every 3 weeks for up to 4 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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