The company received a special protocol assessment letter from the FDA indicating that the trial design is sufficient to support eventual approval of the drug.
The trial is expected to enroll approximately 500 patients with previously untreated stage III or stage IV metastatic melanoma. Patients will receive ipilimumab (10mg/kg) in combination with dacarbazine, or dacarbazine alone 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 progression-free survival as the primary endpoint. Secondary endpoints include overall survival, progression-free survival rate at week 12, best overall objective response rate and duration of responses, and disease control rate (complete and partial responses plus stable disease).
“We believe that the combination of ipilimumab and chemotherapy may provide a potentially important treatment for metastatic melanoma, an area where new therapies are urgently needed,” said Donald Drakeman, president and CEO of Medarex.