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
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Trial sites reduced: 107 → 43 locations
    v32
  2. Site details revised at 3 of 107 sitesv31
  3. Site details revised at 23 of 107 sitesv30
  4. Primary endpoint(s) modifiedv29 Show 4 more changesShow less
    • Enrollment reduced: 362 → 62 participants
    • Interventions: Autogene Cevumeran (Drug), Nivolumab (Drug), Saline (Drug) to Autogene Cevumeran (Drug), Nivolumab (Drug)
    • Secondary endpoints shortened, about 110 words
    • Site details revised at 22 of 107 sites
  5. Study sites revised (107)v28
  6. Primary completion moved earlier from Mar 7, 2029 to Nov 10, 2027
    • Study completion moved earlier from Jan 6, 2034 to Nov 10, 2027
    v27
  7. Study sites: 106 to 107v26
  8. Study sites: 105 to 106v25
  9. Study sites: 100 to 105v24
  10. Study sites: 97 to 100v23
  11. Primary endpoint revisedv22 Show 4 more changesShow less
    • Study sites: 96 to 97
    • Primary completion date: Nov 6, 2028 to Mar 7, 2029
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints revised (8)
  12. Site details revised at 7 of 96 sitesv21
  13. Site details revised at 10 of 96 sitesv20
  14. Site details revised at 94 of 96 sitesv19
  15. Trial status: Suspended to Recruiting
    • Study sites: 95 to 96
    v18
  16. Eligibility criteria expanded, about 48 words
    • Secondary endpoints revised (8)
    v17
  17. Trial status: Recruiting to Suspended Sponsor's reason: This study is on temporary clinical hold following a safety event observed in safety run-in population. The hold will remain in place…
    • Site details revised at 95 of 95 sites
    v16
  18. Site details revised at 7 of 95 sitesv15
  19. Study sites: 87 to 95v14
  20. Study sites: 81 to 87v13
  21. Study sites: 75 to 81v12
  22. Study sites: 76 to 75v11
  23. Start date: Jul 31, 2024 to Dec 9, 2024
    • Study sites: 70 to 76
    v10
  24. Study sites: 62 to 70v9
  25. Site details revised at 1 of 62 sitesv8
  26. Study sites: 7 to 62v7
  27. 2 versions Re-verified since Nov 2, 2024, no change to tracked fieldsv5-v6
  28. Study sites: 3 to 7v4
  29. Study sites: 1 to 3v3
  30. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  31. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Roche/Genentech
368 trials monitored
See 30 trials at risk
Bladder Cancer
1,058 trials monitored
See 79 trials at risk
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.
Trial Details
NCT Number NCT06534983
Lead Sponsor Hoffmann-La Roche
Collaborators: BioNTech SE
Conditions
(from sponsor)		 Muscle-invasive Urothelial Carcinoma
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov