This multicenter, randomized, open-label Phase II study of IMC-1121B is enrolling patients with metastatic malignant melanoma who have not received prior chemotherapy for the disease. A total of 104 patients are expected to be enrolled.
The primary objective of the study is to determine the progression-free survival of patients with previously untreated metastatic malignant melanoma when treated with IMC-1121B alone or in combination with dacarbazine. This Phase II study is designed to evaluate the efficacy, safety and pharmacology of IMC-1121B administered every three weeks by intravenous infusion.
IMC-1121B is ImClone’s fully human IgG1 vascular endothelial growth factor receptor-2 (VEGFR-2) monoclonal antibody that is designed to bind to the VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from binding to and activating the receptor.
Eric Rowinsky, senior vice president and chief medical officer of ImClone, said: “This randomized Phase II study is a component of an ambitious development plan consisting of strategically designed Phase II and Phase III evaluations that ImClone will be rolling out over the next several quarters.”