This phase II trial studies how well nivolumab and ipilimumab work in treating patients with uveal melanoma that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES: I. Overall response rate. SECONDARY OBJECTIVES: I. Progression-free survival. II. Median overall survival. III. One-year overall survival. EXPLORATORY OBJECTIVES: I. Tissue and blood correlates to define immune infiltration and signatures as a result of treatment with nivolumab plus ipilimumab. OUTLINE: INDUCTION PHASE: Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 60 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
M D Anderson Cancer Center
Houston, Texas, United States
Overall Response Rate, Defined Per RECIST 1.1
RECIST 1.1 response is defined as \>=30% reduction in sum of the longest diameter of target lesions
Time frame: Up to 2 years of treatment plus 60 days from last study dose
Progression-Free Survival
Time from enrollment to progressive disease or death. Progressive disease is defined per RECIST 1.1 as \>=20% increase in the sum of the longest diameter of target lesions from nadir, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From date of enrollment until the date of progressive disease or date of death from any cause, whichever came first, and assessed up to 60 days after completion of study treatment, a median of 13.0 months
Overall Survival
Measured from time of enrollment to death
Time frame: From date of enrollment until the date of death from any cause, a median of 13.0 months
1-year Overall Survival
Measured as percentage of patients alive at 1 year from enrollment
Time frame: Baseline up to 1 year
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