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A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Completion moved earlier from Aug 2030 to Nov 2026 Eligibility criteria expanded, about 28 words · Secondary endpoints: details revised at 3 of 7 entries · Site details revised at 4 of 85 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Site details revised at 4 of 85 sites
  2. Study sites: 86 to 85v57
  3. Study sites: 87 to 86v56
  4. Trial sites reduced: 90 → 87 locationsv55
  5. Trial status changed: Recruiting → Active, Not Recruiting Trial sites reduced: 121 → 90 locationsv54 Show 1 more changeShow less
    • Trial sites reduced: 121 → 90 locations
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 8 of 121 sitesv53
  2. Site details revised at 2 of 121 sitesv52
  3. Site details revised at 2 of 121 sitesv51
  4. Site details revised at 5 of 121 sitesv50
  5. Study sites revised (121)v49 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 118 to 121v48
  7. Site details revised at 1 of 118 sitesv47
  8. Site details revised at 1 of 118 sitesv46
  9. Site details revised at 2 of 118 sitesv45
  10. Study sites: 117 to 118v44
  11. Primary completion date: Feb 2026 to Nov 2026 Enrollment target: 229 to 327 · Study sites: 113 to 117 · Completion date: Jul 2027 to Aug 2030 · 2 morev43 Show 5 more changesShow less
    • Enrollment target: 229 to 327
    • Study sites: 113 to 117
    • Completion date: Jul 2027 to Aug 2030
    • Eligibility criteria expanded, about 262 words
    • Study arms: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 1 of 113 sitesv42
  13. Re-verified, no change to tracked fieldsv41
  14. Study sites: 112 to 113v40
  15. Enrollment target: 201 to 229 Interventions: Observational group (no intervention) (Other), RO7198457 intravenous (i.v.) (Drug) to Observational group (no intervention) (Other), RO7198457 intravenous (IV) (Drug) · Eligibility criteria expanded, about 93 wordsv39 Show 2 more changesShow less
    • Interventions: Observational group (no intervention) (Other), RO7198457 intravenous (i.v.) (Drug) to Observational group (no intervention) (Other), RO7198457 intravenous (IV) (Drug)
    • Eligibility criteria expanded, about 93 words

    See this version in full on ClinicalTrials.gov ↗

  16. Site details revised at 2 of 112 sitesv38
  17. Study sites: 110 to 112v37
  18. Study sites: 106 to 110v36
  19. Study sites: 101 to 106v35
  20. Primary completion date: Sep 2023 to Feb 2026 Study sites: 98 to 101v34 Show 1 more changeShow less
    • Study sites: 98 to 101
  21. Study sites: 84 to 98v33
  22. Study sites: 77 to 84v32
  23. Study sites: 69 to 77v31
  24. Study sites: 65 to 69v30
  25. Study sites: 61 to 65v29
  26. Study sites: 53 to 61v28
  27. Study sites: 49 to 53v27
  28. Study sites: 46 to 49v26
  29. Re-verified, no change to tracked fieldsv25
  30. Study Status, Arms and Interventions, Eligibilityv24
  31. Site details revised at 2 of 46 sitesv23
  32. Study sites: 45 to 46v22
  33. Re-verified, no change to tracked fieldsv21
  34. Study sites: 43 to 45v20
  35. Study sites: 42 to 43v19
  36. Study sites: 39 to 42v18
  37. Study sites: 37 to 39v17
  38. Site details revised at 1 of 37 sitesv16
  39. Study sites: 36 to 37v15
  40. Site details revised at 2 of 36 sitesv14
  41. Study sites: 35 to 36v13
  42. Study sites: 28 to 35v12
  43. Study sites: 26 to 28v11
  44. Study sites: 19 to 26v10
  45. Study sites: 17 to 19v9
  • 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.
BioNTech SE
49 trials monitored
See 3 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.
Trial Details
NCT Number NCT04486378
Lead Sponsor BioNTech SE
Collaborators: Genentech, Inc.
Conditions Colorectal Cancer Stage II, Colorectal Cancer Stage III
Enrollment 327 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov