The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the patient's blood that recognize their own tissues, known as "autoimmune" antibodies. Investigators also want to find out how likely it is that their tumor will shrink.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Maximum Tolerated Dose (MTD) of Sylatron
MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).
Time frame: Up to 48 Months
Maximum Tolerated Dose (MTD) of Ipilimumab
MTD of Ipilimumab (Yervoy) combined with peginterferon alfa-2b (Sylatron). To assess the safety, toxicities and tolerability of a regimen of 3 μg/kg weekly Sylatron with concurrent induction Yervoy at 3 mg/kg, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination.
Time frame: Up to 48 Months
Number of Participants With Overall Response (OR)
Overall Response: Complete Response (CR) + Partial Response (PR) by immune-related response criteria (irRC). Immune Related CR (irCR): Complete disappearance of all lesions (whether measurable or not, and no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented. Immure Related PR (irPR): decrease in tumor burden \>50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later.
Time frame: Up to 54 Months
Progression Free Survival (PFS)
Immune Related Progressive Disease (irPD): increase in tumor burden \>25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later.
Time frame: Up to 54 Months
Overall Survival (OS)
OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Time frame: Up to 54 Months
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Treatment Related Adverse Events (AEs) - Grade 3 to 5
Percentage of participants with treatment related AEs, Grade 3 to 5. All adverse events, regardless of causality are also reported in the Serious Adverse Event/Other Adverse Event reporting area.
Time frame: 4 Years, 1 Month