Marc Ernstoff, MD, director of melanoma, Cleveland Clinic, discusses progression-free survival (PFS) and safety in patients with advanced melanoma (MEL) receiving nivolumab (NIVO) combined with ipilimumab (IPI).
Ernstoff describes the 2:1 randomization of this phase II study. He mentions that management of toxicities is still in development, but they immediately stop treatment when autoimmune toxicities occur.
Marc Ernstoff, MD, director of melanoma, Cleveland Clinic, discusses progression-free survival (PFS) and safety in patients with advanced melanoma receiving nivolumab combined with ipilimumab.
FDA Accepts sBLA of Nivolumab Monotherapy for Stage IIB/IIC Melanoma
February 28th 2023Efficacy findings from CheckMate-76 have led the FDA to accept the supplemental biologics license application and the EMA to validate the type II variation marketing authorization application for nivolumab alone in stage IIB or IIC melanoma.
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FDA Greenlights BTD of a Personalized mRNA Vaccine for High-Risk Melanoma
February 23rd 2023The FDA has granted a breakthrough therapy designation to mRNA-4157/V940 based on data from KEYNOTE-942 which showed that the addition of an mRNA vaccine to adjuvant pembrolizumab improved recurrence-free survival following resection of high-risk melanoma.
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