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IMCODE003NCT05968326

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 42 versions: 34 with changes below, 8 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Study sites: 89 to 87
    v42
  2. Site details revised at 68 of 89 sitesv41
  3. Study sites revised (89)v38
  4. Site details revised at 2 of 89 sitesv37
  5. Site details revised at 1 of 89 sitesv35
Show 28 earlier versionsHide 28 earlier versions
  1. Study sites revised (89)v34
  2. Study sites revised (89)v33
  3. Study sites: 88 to 89v32
  4. Eligibility criteria expanded, about 1 word
    • Study sites: 87 to 88
    v30
  5. Primary and study completion dates: Dec 27, 2029 to Jan 1, 2031
    • Site details revised at 2 of 87 sites
    v29
  6. Study sites: 85 to 87v28
  7. Study sites: 84 to 85v27
  8. Study sites: 80 to 84v26
  9. Study sites: 75 to 80v25
  10. Study sites: 69 to 75v24
  11. Study sites: 67 to 69v23
  12. Study sites: 66 to 67v22
  13. Study sites: 56 to 66v21
  14. Study sites: 49 to 56v20
  15. Study sites: 45 to 49v19
  16. Eligibility criteria expanded, about 22 words
    • Study title shortened, about 2 words
    v18
  17. Study sites: 43 to 45v17
  18. Study sites: 39 to 43v15
  19. Study sites: 37 to 39v14
  20. Study sites: 28 to 37v13
  21. Study sites: 22 to 28v12
  22. Primary and study completion dates: May 22, 2029 to Dec 27, 2029
    • Eligibility criteria expanded, about 100 words
    • Study sites: 16 to 22
    v11
  23. Study sites: 14 to 16v10
  24. Study sites: 12 to 14v9
  25. Site details revised at 1 of 12 sitesv8
  26. Study sites: 8 to 12v5
  27. Study sites: 7 to 8
    • Start date: Oct 5, 2023 to Oct 18, 2023
    v4
  28. Start date: Jul 22, 2023 to Oct 5, 2023
    • Study sites: 1 to 7
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Disease Free Survival (DFS)
Timeframe: From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years

Secondary (4)

DFS Rates at 12, 24, and 36 Months
Overall Survival (OS)
OS Rates at 3 and 5 Years
Percentage of Participants With Adverse Events (AEs)

Arms and interventions

Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOXExperimental

Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

Arm 2: mFOLFIRINOXActive comparator

Participants will receive mFOLFIRINOX.

Drugs: Autogene cevumeran, Atezolizumab, mFOLFIRINOX

Sites

87 sites in 10 countries

United States 30, Germany 13, Spain 10, United Kingdom 8, South Korea 7, Belgium 5, France 5, Canada 4, Netherlands 3, Sweden 2