FDAnews

MEDAREX BEGINS TRIAL OF IPILIMUMAB

Medarex has launched a registrational clinical trial of ipilimumab (MDX-010) used as a monotherapy in previously-treated (second-line) metastatic melanoma patients. The open label, single-arm, monotherapy registrational clinical trial is expected to enroll approximately 150 patients with unresectable Stage III or Stage IV metastatic melanoma who have progressed after at least one prior regimen of another melanoma treatment other than ipilimumab.

Patients will receive a dose of 10 mg/kg of ipilimumab once every three weeks for up to four doses. Subsequently, eligible patients who have not experienced disease progression at Week 24 will continue in a maintenance phase where a single dose of ipilimumab will be administered once every 12 weeks until disease progression. The study is designed to assess best objective response rate (complete and partial responses) as the primary endpoint.