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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Given IV
Given via hepatic arterial infusion
Correlative studies
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Number of patients that experience grade 3-4 toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Up to 3 weeks after discontinuation of study treatment
Number of patients with an overall response of liver metastasis according to Response Evaluation Criteria in Solid Tumors (RECIST)
Sequential hepatic radioembolization and systemic ipilimumab will be considered potentially efficacious if \>3/12 patients achieve objective responses because the upper limit of the corresponding exact 95% confidence interval will be \>57%. The best overall response of liver metastases, from the start of hepatic radioembolization will be used for the efficacy analysis.
Time frame: Up to 5 years
Overall survival
Number of patients still alive after 5 years.
Time frame: From the hepatic radioembolization procedure until death, assessed up to 5 years
Progression-free (PFS) survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
Number of patients progression free survival at 5 years. Hepatic and extrahepatic PFS will be evaluated separately.
Time frame: From the hepatic radioembolization to confirmation of progression or death, assessed up to 5 years
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