This phase II trial studies ipilimumab and nivolumab with immunoembolization in treating patients with uveal melanoma that has spread to the liver. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunoembolization may kill tumor cells due to loss of blood supply and develop an immune response against tumor cells. Giving ipilimumab and nivolumab with immunoembolization may work better in treating patients with uveal melanoma.
PRIMARY OBJECTIVES: I. Determine the clinical benefit of treatment with immunoembolization (IEMBO) in combination with ipilimumab and nivolumab. SECONDARY OBJECTIVES: I. Determine all treatment and immune related toxicities. II. Determine progression free survival. III. Determine overall survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Defined as complete response + partial response + stable disease. Rated by Response Evaluation Criteria in Solid Tumors version 1.1. The estimate of the hepatic metastasis stabilization rate will be presented with corresponding 95% confidence intervals. The method of Atkinson and Brown will be used to adjust for the two-stage design.
Time frame: At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days.
Number of Participants With Adverse Events
Graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity rates will be estimated with corresponding 95% confidence intervals.
Time frame: Up to 1 year
Progression Free Survival (PFS)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Will be estimated using the Kaplan-Meier method.
Time frame: From the start of the treatment to confirmation of progression of disease, assessed up to 1 year
Overall Survival
Will be estimated using the Kaplan-Meier method.
Time frame: up to 2 years
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