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Study identifier: NCT06534983 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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)

Condition: Muscle-invasive Urothelial Carcinoma  ·  Sponsor: Hoffmann-La Roche

PhasePhase 2
Planned participants62
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The original purpose of this study was 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 nivolumab monotherapy arm. Following the Sponsor's decision to phase out the study, as of Protocol Version 5, the primary purpose of the study is to ensure treatment continuity and safety for the participants who continue to participate in the study and receive study treatment.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: BO45230 https://forpatients.roche.com/ No attachments to email below.  ·  888-662-6728 (U.S. Only)  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Always discuss trial participation with your own doctor first.

Locations (107)

Highlands Oncology Group.Springdale, Arkansas, United StatesWithdrawn
Kaiser Permanente - Baldwin ParkBaldwin Park, California, United StatesWithdrawn
City of Hope Cancer CenterDuarte, California, United StatesWithdrawn
Kaiser Permanente - Los Angeles (N. Vermont)Los Angeles, California, United StatesWithdrawn
Kaiser Permanente - RiversideRiverside, California, United StatesWithdrawn
University of California San FranciscoSan Francisco, California, United StatesWithdrawn
Yale Cancer CenterNew Haven, Connecticut, United StatesWithdrawn
Georgetown University Medical Center Lombardi Cancer CenterWashington D.C., District of Columbia, United StatesWithdrawn
Norton Cancer InstituteLouisville, Kentucky, United StatesWithdrawn
Henry Ford Health SystemDetroit, Michigan, United StatesWithdrawn
Memorial Sloan Kettering Cancer Center Basking RidgeBasking Ridge, New Jersey, United StatesRecruiting
MSK MonmouthMiddletown, New Jersey, United StatesRecruiting

+ 95 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06534983