A randomized phase ii, double-blind, multicenter study evaluating the efficacy and safety of autogene cevumeran plus nivolumab versus placebo plus nivolumab as adjuvant therapy in patients with high-risk muscle-invasive urothelial carcinoma

A personalised cancer vaccine is being tested alongside an immunotherapy drug to see if it can prevent bladder cancer from returning after surgery. This matters because muscle-invasive urothelial carcinoma (MIUC) has a high risk of recurrence even after the bladder is removed. Current standard care—nivolumab alone—reduces that risk but does not eliminate it. The experimental vaccine, autogene cevumeran, is custom-built for each patient from their tumour’s genetic material, designed to train the immune system to recognise and destroy any remaining cancer cells. The trial is double-blind: neither patients nor doctors will know who receives the vaccine plus nivolumab versus a saline placebo plus nivolumab. If the combination proves more effective than nivolumab alone, it could become a new adjuvant therapy for high-risk MIUC, potentially reducing relapse rates and improving survival without adding major toxicity. The study will recruit 23 participants in the UK and 362 worldwide, with treatment spanning roughly 21 months. The results will determine whether personalised vaccines can meaningfully improve outcomes in this aggressive cancer.