Oct 8 2013
The Melanoma Research Foundation Breakthrough Consortium (MRFBC) has launched a new clinical trial to assess the impact of concomitant administration of bevacizumab (Avastin) with vemurafenib (Zelboraf) in patients with BRAFV600 mutation positive metastatic melanoma.
MRFBC has selected Biologics to be its sole distribution partner in overseeing the trial's drug supply, patient-specific distribution, and accountability reporting. Biologics will also provide a customized quality assurance program to ensure randomization is upheld and to reduce waste.
The primary objective of the trial is to assess the progression-free survival of patients on bevacizumab and vemurafinib compared to patients treated with vemurafenib alone. Secondary objectives include assessing response rate and overall survival of patients. As the combination of vemurafenib and bevacizumab has not previously been investigated, this study will also evaluate the impact of bevacizumab on vemurafenib-induced toxicity. The goal is to enroll 180 patients who meet certain eligibility criteria.
"We're thrilled to have the opportunity to support MRFBC in this important trial," said Karl Buer, program lead for Biologics. "This study presents an exciting opportunity to enhance the effectiveness of an important therapy in one of the most treatment-resistant malignancies."
Elderly population faces escalating melanoma incidence over three decades