Following the receipt of approval from the Investigational Review Board, the study is expected to enroll patients in the summer of 2013.
University of Texas M.D. Anderson Cancer Center, Cancer Medicine Division Melanoma Medical Oncology Department assistant professor and PROCLIVITY 02 trial co-principal investigator Sapna Patel said sequential treatment with two complementary immunotherapies may improve upon the clinical endpoints seen with HD IL-2 alone.
"By administering HD IL-2 followed by ipilimumab, or vice versa, we aim to assess whether the one-year survival is improved over historical controls, and to observe whether one sequence has an advantage over the other regarding practical administration and complete response rate," Dr. Patel added.
Approximately 120 mM patients will be enrolled in the randomized open-label, two-arm study, with 60 patients assigned to each treatment arm.
Patients being enrolled will be those who are treatment-naïve or have previously received a single non-immunologic therapy.
The Treatment Arm 1patients will receive four cycles of HD IL-2 followed by one course of the monoclonal antibody ipilimumab 3 mg/kg intravenously every 3 weeks, for a total of four doses.
Patients in Treatment Arm 2 will receive the study drugs in the opposite sequence, four doses of ipilimumab followed by four cycles of HD IL-2.
The study’s primary endpoint is overall survival at one year in those receiving more than 50% of the planned cycles of both study drugs.
The Proclivity 01 trial cleared its primary safety review by an independent Safety Monitoring Committee involving eight patients initially who are treated with emurafenib and two cycles of HD IL-2.