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A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Study sites: 196 to 197 · Eligibility criteria expanded, about 22 words · Secondary endpoints: details revised at 6 of 7 entries Show 3 more changesShow less
    • Study sites: 196 to 197
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 6 of 7 entries
  2. Study sites: 195 to 196v41
  3. Study sites: 194 to 195v40
  4. Trial sites expanded: 191 → 194 locationsv39
  5. Trial sites expanded: 187 → 191 locationsv38
Show 2 earlier versionsHide 2 earlier versions
  1. Secondary endpoints: details revised at 6 of 7 entriesv37
  2. Study sites: 186 to 187 Eligibility criteria expanded, about 12 words · Secondary endpoints revised (7) · Primary endpoints revised (3)v36 Show 3 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (7)
    • Primary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  1. Trial sites expanded: 183 → 186 locationsv35
  2. Study sites: 181 to 183v34
  3. Trial sites expanded: 178 → 181 locationsv33
  4. Trial sites expanded: 174 → 178 locationsv32
  5. Study sites: 172 to 174v31
  6. Study sites: 170 to 172v30
  7. Study sites: 168 to 170v29
  8. Study sites: 167 to 168v28
  9. Trial sites expanded: 164 → 167 locationsv27
  10. Trial sites expanded: 159 → 164 locationsv26
  11. Trial sites expanded: 155 → 159 locationsv25
  12. Trial sites expanded: 152 → 155 locationsv24
  13. Trial sites expanded: 140 → 152 locationsv23
  14. Trial sites expanded: 134 → 140 locationsv22
  15. Study sites: 125 to 134v21
  16. Study sites: 100 to 125v20
  17. Re-verified, no change to tracked fieldsv19
  18. Study sites: 70 to 100 Completion date: Oct 15, 2032 to Nov 9, 2032 · Eligibility criteria expanded, about 23 words · Study title expanded, about 1 wordv18 Show 3 more changesShow less
    • Completion date: Oct 15, 2032 to Nov 9, 2032
    • Eligibility criteria expanded, about 23 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 59 to 70v17
  20. Study sites: 35 to 59v16
  21. Study sites: 30 to 35v15
  22. Site details revised at 1 of 30 sitesv14
  23. Study sites: 29 to 30v13
  24. Site contacts updated at 1 of 29 sitesv12
  25. Study sites: 28 to 29v11
  26. Site contacts updated at 1 of 28 sitesv10
  27. Study sites: 27 to 28v9
  28. Study sites: 26 to 27v8
  29. Study sites: 21 to 26v7
  30. Study sites: 14 to 21v6
  31. Study sites: 8 to 14 Completion date: Jun 27, 2031 to Oct 15, 2032 · Start date changed from estimate of Apr 16, 2025 to Apr 9, 2025v5 Show 2 more changesShow less
    • Completion date: Jun 27, 2031 to Oct 15, 2032
    • Start date changed from estimate of Apr 16, 2025 to Apr 9, 2025
  32. Study sites: 3 to 8 Start date: Mar 19, 2025 to Apr 16, 2025 · Eligibility criteria expanded, about 18 wordsv4 Show 2 more changesShow less
    • Start date: Mar 19, 2025 to Apr 16, 2025
    • Eligibility criteria expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  33. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 3 · Primary completion date: Apr 9, 2030 to Apr 27, 2029 · Completion date: Oct 15, 2032 to Jun 27, 2031 · 1 morev3 Show 4 more changesShow less
    • Study sites: 1 to 3
    • Primary completion date: Apr 9, 2030 to Apr 27, 2029
    • Completion date: Oct 15, 2032 to Jun 27, 2031
    • Start date: Mar 5, 2025 to Mar 19, 2025
  34. Study sites: 0 to 1v2
  35. Study First Submitted
  • 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
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.
Trial Details
NCT Number NCT06824467
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Conditions Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Enrollment 770 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov