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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)

Study acronym: IMCODE004
StatusActive, Not Recruiting
PhasePhase 2
Started2024-12-09
View on ClinicalTrials.gov ↗
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.

Amendment history 6 changes detected by DataLookout

2026-08-07
notable
Enrollment closed, study ongoing
2026-08-07
minor
Trial sites reduced: 107 → 43 locations
2026-06-09
critical
Primary endpoint(s) modified
WasInvestigator-assessed (INV) Disease-free Survival (DFS)
NowNumber of Participants With Adverse Events (AEs)
2026-06-09
critical
Enrollment reduced: 362 → 62 participants
2026-04-10
minor
Primary completion moved earlier: 2029-03-07 → 2027-11-10
2026-04-10
minor
Completion moved earlier: 2034-01-06 → 2027-11-10
Trial Details
NCT Number NCT06534983
Lead Sponsor Hoffmann-La Roche
Collaborators: BioNTech SE
Conditions Muscle-invasive Urothelial Carcinoma
Enrollment 62 participants
Start Date 2024-12-09
Primary Completion 2027-11-10 (estimated)
Study Completion 2027-11-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-06