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**Autogene cevumeran + nivolumab** is an investigational combination therapy comprising a personalized, mRNA-based cancer vaccine (autogene cevumeran) and the PD-1 checkpoint inhibitor nivolumab. **Autogene cevumeran** is a uridine mRNA lipoplex vaccine custom-manufactured for each patient, encoding up to 20 neoantigens derived from the individual's tumor mutations, designed to stimulate strong CD4+ and CD8+ T cell responses against the patient’s cancer. **Nivolumab** is a human monoclonal antibody that blocks the PD-1 receptor on T cells, releasing inhibition on immune responses and enhancing anti-tumor activity. The combination is under investigation to increase immunogenicity and improve clinical outcomes versus checkpoint inhibitor alone in cancers such as high-risk muscle-invasive urothelial carcinoma (MIUC) and is being studied in a randomized clinical trial after bladder cancer surgery. Autogene cevumeran is produced using tumor sequencing and computational prediction of neoantigen targets, while nivolumab acts broadly to prevent immune evasion.
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