iSCIB1+ in Combination With Ipilimumab and Nivolumab as First-Line Treatment for Advanced Unresectable Melanoma

This Phase 3 clinical trial is evaluating whether adding iSCIB1+, an investigational DNA-based cancer vaccine, to standard immunotherapy with nivolumab and ipilimumab can improve outcomes for people with advanced unresectable melanoma. Participants will be randomly assigned to receive either iSCIB1+ or a placebo, in addition to standard treatment with nivolumab and ipilimumab. Neither participants nor study doctors will know which treatment has been assigned. The study will compare how long participants live without their cancer worsening, overall survival, tumor response, safety, and quality of life. iSCIB1+ is designed to stimulate the immune system to recognize and attack melanoma cells by targeting proteins commonly found on melanoma tumors. Earlier studies have shown encouraging signs of immune activation and anti-tumor activity when iSCIB1+ was combined with checkpoint inhibitor immunotherapy. This study aims to determine whether adding iSCIB1+ to standard immunotherapy provides additional benefit compared with standard immunotherapy alone