Medarex begins ipilimumab cancer trials

New Jersey, USA-headquartered Medarex says it has begun a registrational clinical trial of ipilimumab (MDX-010) used as a monotherapy for treatment-experienced metastatic melanoma patients. The drug has been developed in collaboration with US drug major Bristol-Myers Squibb, under an agreement established in 2004 (Marketletters passim).

The study, which is an open-label, single-arm registrational trial, will enroll around 150 patients with unresectable Stage III or IV metastatic melanoma. Subjects will receive a 10mg/kg dose of the drug on a three-weekly basis, for a total of four treatments. Those patients that have not experienced disease progression at week 12 will move into a maintenance trial, during which a single dose of the compound will be given once every 12 weeks. The program will assess objective response rates, both complete and partial, in addition to establishing the product's safety and tolerability.