Morrisville, N.C.-based Clinipace Worldwide, a global digital research organization (dCRO), said Prometheus Laboratories, a specialty pharmaceutical and diagnostic company, has awarded it an Oncology Program. Immediate plans are commencing for two metastatic melanoma studies.
Initially, Clinipace Worldwide will manage a study of Proleukin (aldesleukin) and Vemurafenib therapy in patients with metastatic melanoma (mM). This study is expected to include up to 30 sites in the U.S. with a sample size of 135 patients in the naïve patient arm. The study is expected to enroll patients over an 18-month period, with additional follow-up of two years required. Proleukin remains the only therapy to deliver durable remissions in metastatic renal cell carcinoma and metastatic melanoma.
A second study will compare the sequence of high-dose Proleukin (aldesleukin) and 3mg/kg Ipilimumab immunotherapy in patients with metastatic melanoma. The study will enroll up to 120 patients at approximately 15 study sites around the U.S.
“Patient enrollment is one of the biggest challenges we face when starting an oncology trial; thus, it was critically important for us to team with a CRO we felt could provide oncology expertise along with a robust electronic data management platform,” said Todd Butler, director of clinical operations for Prometheus. “We will be able to monitor our studies to ensure they are on track right from the start; specifically, the number of patients enrolled at each of our sites, as well as factors that impact enrollment and protocol compliance. With the ability to monitor these critical areas in real-time, the study teams will have the ability to adjust patient enrollment strategies with improved data quality.”
“Embracing technology can be on one of the most powerful and cost-effective ways to enhance the success of a clinical trial,” said Jeff Williams, CEO of Clinipace Worldwide. “By partnering with a digital CRO, you can be assured of safer trials and higher quality data delivered more efficiently and cost-effectively.”