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Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Study acronym: OMAHA-003
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 74 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Eligibility criteria expanded, about 50 words · Secondary endpoints: details revised at 4 of 10 entries · Study sites revised (288) Show 3 more changesShow less
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: details revised at 4 of 10 entries
    • Study sites revised (288)
  2. Study sites revised (288)v73 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 1 of 288 sitesv72
  4. Trial sites expanded: 282 → 288 locationsv71
  5. Secondary endpoints: details revised at 1 of 10 entriesv70
  6. Completion pushed from Aug 2, 2028 to Feb 15, 2030v69
  7. Study sites: 281 to 282v68
  8. Site details revised at 1 of 281 sitesv67
  9. Site details revised at 5 of 281 sitesv66
  10. Site details revised at 1 of 281 sitesv65
  11. Re-verified, no change to tracked fieldsv64
  12. Site details revised at 1 of 281 sitesv63
  13. Site details revised at 2 of 281 sitesv62
  14. Site details revised at 2 of 281 sitesv61
  15. Site details revised at 4 of 281 sitesv60
  16. Site details revised at 3 of 281 sitesv59
  17. Site details revised at 7 of 281 sitesv58
  18. Site details revised at 4 of 281 sitesv57
  19. Site details revised at 12 of 281 sitesv56
  20. Site details revised at 20 of 281 sitesv55
  21. Site details revised at 13 of 281 sitesv54
  22. Site details revised at 20 of 281 sitesv53
  23. Site details revised at 6 of 281 sitesv52
  24. Site details revised at 9 of 281 sitesv51
  25. Study sites: 279 to 281v50
  26. Site details revised at 32 of 279 sitesv49
  27. Site details revised at 35 of 279 sitesv48
  28. Site details revised at 8 of 279 sitesv47
  29. Site details revised at 6 of 279 sitesv46
  30. Site details revised at 12 of 279 sitesv45
  31. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 1200 to 1310 · Eligibility criteria expanded, about 6 words · Site details revised at 279 of 279 sitesv44 Show 3 more changesShow less
    • Enrollment target: 1200 to 1310
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 279 of 279 sites

    See this version in full on ClinicalTrials.gov ↗

  32. Re-verified, no change to tracked fieldsv43
  33. Trial status: Recruiting to Active, Not Recruiting Site details revised at 279 of 279 sitesv42 Show 1 more changeShow less
    • Site details revised at 279 of 279 sites
  34. Site details revised at 12 of 279 sitesv41
  35. Site details revised at 20 of 279 sitesv40
  36. Study sites: 275 to 279v39
  37. Site details revised at 9 of 275 sitesv38
  38. Site details revised at 28 of 275 sitesv37
  39. Study sites revised (275)v36 See this version in full on ClinicalTrials.gov ↗
  40. Study sites: 272 to 275v35
  41. Study sites: 263 to 272v34
  42. Study sites: 260 to 263v33
  43. Study sites: 254 to 260v32
  44. Study sites: 252 to 254v31
  45. Study sites: 245 to 252v30
  46. Study sites: 242 to 245v29
  47. Study sites: 240 to 242v28
  48. Study sites: 233 to 240v27
  49. Study sites: 232 to 233v26
  50. Study sites: 208 to 232v25
  • 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.
Merck (MSD)
407 trials monitored
See 29 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.
Trial Details
NCT Number NCT06136624
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Prostate Cancer Metastatic
Enrollment 1,310 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov