Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy. Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab. Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intravenous bolus (IVB) every 8 hours for up to 14 planned doses with an additional cycle 14 days after the first. Ipilimumab 3mg/kg IV infusion Q3 weeks up to 4 doses4 doses A 3-6 week interval been the administration of the two drugs to allow for resolution of treatment-related toxicities. If corticosteroids were required during Ipilimumab administration, a 2-week period from discontinuation of steroid treatment to start of HD IL-2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
The University of Arizona Cancer Center
Tucson, Arizona, United States
Moores UCSD Cancer Center
La Jolla, California, United States
MSMC Research Program
Miami Beach, Florida, United States
Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately
evaluable patients who received at least 50% of both research drugs and had their disease re-evaluated after baseline; defined in days for the start of the first treatment to death. percent of patients alive at 1 year; estimates were assessed using Kaplan-Meier method for the entire subject population for each treatment arm separately.
Time frame: start of first treatment to date of death from any cause and patients alive at their last evaluation date were censored up to 1 year.
Progression-free Survival
duration of time (in Days) from start of the first treatment to the time of objective disease progression or death at one year. The immune-related response criteria (irRC) determined based on tumor burden calculated on the WHO method of multiplying the perpendicular dimensions of all lesions are summed to obtain the tumor burden. The total tumor burden + SPD (index lesions) + SPD (new measurable lesions) Based on CT scans and Physical exam at designated timepoints. CR- Disappearance of all known disease; PR\>/equal to decrease; SD Neither CR or PD; PD 25%increase; new lesion.
Time frame: 5-11 weeks, 13-19 Weeks, 24-30 weeks and 1 year
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Oncology Specialists, SC
Park Ridge, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Johns Hopkins Medicine
Lutherville, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Nebraska Cancer Specialists, Midwest Cancer Center - Legacy
Omaha, Nebraska, United States
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
...and 2 more locations