A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) (IMCODE004)

Complete Title: 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
Trial Phase: II
Investigator: Petros Grivas

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 randomization in either autogene cevumeran + nivolumab or the saline + nivolumab arm.

Look up Trial at NIH
Keywords:
  • Urothelial Cancer
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