The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC.
In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the saline + nivolumab arm.
Conditions: Muscle-invasive Urothelial Carcinoma
Interventions: Autogene Cevumeran, Nivolumab, Saline
Lead Sponsor: Hoffmann-La Roche
Planned Enrollment: 362 participants