Medarex to start ipilimumab trial

By Elaine Rigoli

Tampa, Fla., June 19 - Medarex, Inc. has received a Special Protocol Assessment letter from the Food and Drug Administration to start a registrational clinical trial of ipilimumab (MDX-010) used in combination with chemotherapy in previously untreated metastatic melanoma patients.

The SPA agreement with the FDA concerns the suitability of the trial design to support regulatory approval.

The randomized, double-blind, two-arm registrational clinical trial is expected to begin shortly.

The trial will enroll about 500 patients with previously untreated stage 3 or stage 4 metastatic melanoma, according to a news release.

Patients will receive ipilimumab (10 mg/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 release said.

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).

Medarex is a biopharmaceutical company based in Princeton, N.J.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.