Condition: Muscle-invasive Urothelial Carcinoma · Sponsor: Hoffmann-La Roche
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.
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.
| Highlands Oncology Group. | Springdale, Arkansas, United States | Withdrawn |
| Kaiser Permanente - Baldwin Park | Baldwin Park, California, United States | Withdrawn |
| City of Hope Cancer Center | Duarte, California, United States | Withdrawn |
| Kaiser Permanente - Los Angeles (N. Vermont) | Los Angeles, California, United States | Withdrawn |
| Kaiser Permanente - Riverside | Riverside, California, United States | Withdrawn |
| University of California San Francisco | San Francisco, California, United States | Withdrawn |
| Yale Cancer Center | New Haven, Connecticut, United States | Withdrawn |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C., District of Columbia, United States | Withdrawn |
| Norton Cancer Institute | Louisville, Kentucky, United States | Withdrawn |
| Henry Ford Health System | Detroit, Michigan, United States | Withdrawn |
| Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge, New Jersey, United States | Recruiting |
| MSK Monmouth | Middletown, New Jersey, United States | Recruiting |
+ 95 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06534983