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IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 56 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoints: 2 to 3 Trial status: Recruiting to Active, Not Recruiting · Eligibility criteria expanded, about 34 words · Secondary endpoints: 8 to 11 · 2 morev56 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: 8 to 11
    • Study description expanded, about 9 words
    • Site details revised at 68 of 68 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Site contacts updated at 1 of 68 sitesv55
  3. Minor Study sites: 67 to 68v54
  4. Minor Site details revised at 3 of 67 sitesv53
  5. Minor Study sites: 66 to 67v52
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Site details revised at 1 of 66 sitesv51
  2. Minor Site details revised at 3 of 66 sitesv50
  3. Minor Site details revised at 1 of 66 sitesv49
  4. Minor Site details revised at 1 of 66 sitesv48
  5. Minor Site details revised at 3 of 66 sitesv47
  6. Minor Site details revised at 1 of 66 sitesv46
  7. Minor Site contacts updated at 1 of 66 sitesv45
  8. Minor Site details revised at 1 of 66 sitesv44
  9. Minor Site details revised at 1 of 66 sitesv43
  10. Minor Site details revised at 1 of 66 sitesv42
  11. Minor Site details revised at 2 of 66 sitesv41
  12. Minor Site details revised at 6 of 66 sitesv40
  13. Minor Enrollment target: 380 to 420 Eligibility criteria expanded, about 33 wordsv39 Show 1 more changeShow less
    • Eligibility criteria expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  14. Minor Site details revised at 5 of 66 sitesv38
  15. Minor Site details revised at 4 of 66 sitesv37
  16. Minor Site contacts updated at 1 of 66 sitesv36
  17. Minor Study sites revised (66)v35 See this version in full on ClinicalTrials.gov ↗
  18. Minor Site details revised at 1 of 66 sitesv34
  19. Minor Site details revised at 1 of 66 sitesv33
  20. Minor Site details revised at 1 of 66 sitesv32
  21. Minor Site details revised at 1 of 66 sitesv31
  22. Minor Site details revised at 1 of 66 sitesv30
  23. Minor Site contacts updated at 3 of 66 sitesv29
  24. Minor Study sites: 65 to 66v28
  25. Minor Study sites: 63 to 65v27
  26. Minor Site details revised at 1 of 63 sitesv26
  27. Minor Site contacts updated at 1 of 63 sitesv25
  28. Minor Site details revised at 1 of 63 sitesv24
  29. Minor Site contacts updated at 1 of 63 sitesv23
  30. Minor Site details revised at 1 of 63 sitesv22
  31. Minor Site details revised at 2 of 63 sitesv21
  32. Minor Site details revised at 3 of 63 sitesv20
  33. Minor Site details revised at 2 of 63 sitesv19
  34. Minor Site details revised at 17 of 63 sitesv18
  35. Minor Site details revised at 10 of 63 sitesv17
  36. Minor Site details revised at 1 of 63 sitesv16
  37. Minor Site details revised at 5 of 63 sitesv15
  38. Minor Study sites: 54 to 63v14
  39. Minor Study sites: 55 to 54v13
  40. Minor Study sites: 54 to 55v12
  41. Minor Site details revised at 2 of 54 sitesv11
  42. Minor Study sites revised (54)v10 See this version in full on ClinicalTrials.gov ↗
  43. Minor Study sites: 47 to 54v9
  44. Minor Start date changed from estimate of Oct 2023 to Oct 31, 2023 Site contacts updated at 1 of 47 sitesv8 Show 1 more changeShow less
    • Site contacts updated at 1 of 47 sites
  45. Minor Study sites: 28 to 47v7
  • 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.
1,026 trials monitored
See 48 trials at risk
This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A\*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).
Trial Details
NCT Number NCT05987332
Lead Sponsor IDEAYA Biosciences
Conditions Metastatic Uveal Melanoma
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov