A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

PI: Dr. Michele Del Vecchio 

This is a phase 3, open-label, randomized, study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma. 

The principal object of this study is to verify if the study drug (IMC-F106C), in combination with a standard therapy (nivolumab), works better than the standard therapy (nivolumab) in stopping the growth of tumors. A second object is to understand the safety profile of IMC-F106C in combination with nivolumab and to understand whether a lower or higher dose of IMC-F106C in combination with this standard therapy works better and/or is safer.  

This study will also examine patients’ quality of life after receiving the study drug or standard therapy.