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A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Study acronym: INTerpath-002
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 99 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Enrollment closed, study ongoing · Study sites revised (229) Show 2 more changesShow less
    • Enrollment closed, study ongoing
    • Study sites revised (229)
  2. Study sites: 228 to 229v98
  3. Study sites: 229 to 228v97
  4. Site details revised at 7 of 229 sitesv96
  5. Site details revised at 1 of 229 sitesv95
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 229 sitesv94
  2. Site details revised at 5 of 229 sitesv93
  3. Site details revised at 4 of 229 sitesv92
  4. Study sites revised (229)v91 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 2 of 229 sitesv90
  6. Site details revised at 9 of 229 sitesv89
  7. Site details revised at 5 of 229 sitesv88
  8. Site details revised at 13 of 229 sitesv87
  9. Study sites: 228 to 229v86
  10. Re-verified, no change to tracked fieldsv85
  11. Study sites: 226 to 228v84
  12. Site details revised at 5 of 226 sitesv83
  13. Study sites: 225 to 226v82
  14. Study sites: 224 to 225v81
  15. Study sites: 223 to 224v80
  16. Study sites: 220 to 223v79
  17. Site details revised at 1 of 220 sitesv78
  18. Study sites: 217 to 220v77
  19. Site contacts updated at 3 of 217 sitesv76
  20. Site details revised at 4 of 217 sitesv75
  21. Study sites: 216 to 217v74
  22. Study sites: 215 to 216v73
  23. Site details revised at 2 of 215 sitesv72
  24. Site contacts updated at 1 of 215 sitesv71
  25. Study sites: 213 to 215v70
  26. Study sites: 212 to 213v69
  27. Site contacts updated at 7 of 212 sitesv68
  28. Study sites: 208 to 212v67
  29. Study sites: 202 to 208v66
  30. Study sites revised (202)v65 See this version in full on ClinicalTrials.gov ↗
  31. Study sites: 199 to 202v64
  32. Study sites: 197 to 199v63
  33. Study sites: 196 to 197v62
  34. Study sites: 195 to 196v61
  35. Site contacts updated at 3 of 195 sitesv60
  36. Study sites revised (195)v59 See this version in full on ClinicalTrials.gov ↗
  37. Study sites: 194 to 195v58
  38. Study sites: 193 to 194v57
  39. Study sites: 189 to 193v56
  40. Study sites: 188 to 189v55
  41. Site details revised at 9 of 188 sitesv54
  42. Study sites: 187 to 188v53
  43. Interventions: Pembrolizumab (Biological), Placebo (Other), V940 (Biological) to Intismeran autogene (Biological), Pembrolizumab (Biological), Placebo (Other)v52
  44. Study sites: 182 to 187v51
  45. Site contacts updated at 8 of 182 sitesv50
  • 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.
The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
Trial Details
NCT Number NCT06077760
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: ModernaTX, Inc.
Conditions Non-small Cell Lung Cancer
Enrollment 868 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov