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Duration of Anti-PD-1 Therapy in Metastatic Melanoma

Study acronym: STOP-GAP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 60 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor Site details revised at 1 of 30 sitesv60
  2. Minor Re-verified, no change to tracked fieldsv59
  3. Minor Site contacts updated at 1 of 30 sitesv58
  4. Minor Site details revised at 1 of 30 sitesv57
  5. Minor Study sites: 31 to 30v56
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Site contacts updated at 1 of 31 sitesv55
  2. Minor Study sites revised (31)v54
  3. Minor Study sites revised (31)v53
  4. Minor Study sites: 32 to 31v52
  5. Minor Study sites revised (32)v51
  6. Minor Site contacts updated at 1 of 32 sitesv50
  7. Minor Study sites revised (32)v49
  8. Minor Study sites: 31 to 32v48
  9. Minor Site contacts updated at 1 of 31 sitesv47
  10. Minor Site contacts updated at 1 of 31 sitesv46
  11. Notable Start date: Jul 4, 2016 to Oct 31, 2016v45
  12. Minor Study sites: 30 to 31v44
  13. Minor Site details revised at 1 of 30 sitesv43
  14. Minor Study sites: 29 to 30v42
  15. Minor Site details revised at 1 of 29 sitesv41
  16. Minor Study sites: 30 to 29v40
  17. Minor Eligibility criteria revisedv39
  18. Minor Site contacts updated at 1 of 30 sitesv38
  19. Minor Study sites: 29 to 30v37
  20. Minor Site contacts updated at 1 of 29 sitesv36
  21. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2027
    • Study completion date: Dec 31, 2025 to Dec 31, 2029
    v35
  22. Minor Study sites: 28 to 29v34
  23. Minor Site details revised at 1 of 28 sitesv33
  24. Minor Site details revised at 1 of 28 sitesv32
  25. Minor Site details revised at 1 of 28 sitesv31
  26. Minor Eligibility criteria expanded, about 46 wordsv30
  27. Minor Study sites: 27 to 28v29
  28. Minor Site details revised at 2 of 27 sitesv28
  29. Minor Primary completion date: Dec 2023 to Dec 31, 2023
    • Study completion date: Dec 2025 to Dec 31, 2025
    • Study title shortened, about 1 word
    v27
  30. Minor Study sites: 23 to 27v26
  31. Minor Study sites: 20 to 23v25
  32. Minor Study sites: 19 to 20v24
  33. Minor Interventions: Continuous PD-1 inhibitor therapy (Other), Intermittent PD-1 inhibitor therapy (Other) to Continuous PD-1 inhibitor therapy (Drug), Intermittent PD-1 inhibitor therapy (Drug)
    • Study sites revised (19)
    v23
  34. Minor Re-verified, no change to tracked fieldsv22
  35. Minor Study sites: 17 to 19v21
  36. Minor Study sites: 18 to 17v20
  37. Minor Site contacts updated at 1 of 18 sitesv19
  38. Minor Study sites: 19 to 18v18
  39. Minor Study sites: 18 to 19v17
  40. Minor Study sites: 17 to 18v16
  41. Minor Enrollment target: 550 to 614
    • Eligibility criteria shortened, about 117 words
    • Secondary endpoints: details revised at 6 of 6 entries
    v15
  42. Minor Study sites: 16 to 17v14
  43. Minor Eligibility criteria expanded, about 99 words
    • Collaborators expanded, about 6 words
    v13
  44. Minor Study sites: 15 to 16v12
  45. Minor Study sites: 14 to 15v11
  • 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 purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.
Trial Details
NCT Number NCT02821013
Lead Sponsor Canadian Cancer Trials Group
Collaborators: Melanoma and Skin Cancer Trials Limited
Conditions
(from sponsor)
Unresectable/Metastatic Melanoma
Related terms Melanoma
Enrollment 614 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov