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A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)

Study acronym: TroFuse-033
StatusRecruiting
PhasePhase 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. Minor Study sites: 264 to 265
  2. Notable Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Study sites: 263 to 264 · Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 5 of 7 entries Show 3 more changesShow less
    • Study sites: 263 to 264
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 5 of 7 entries
  3. Minor Study sites: 262 to 263v54
  4. Minor Site contacts updated at 1 of 262 sitesv53
  5. Minor Study sites: 260 to 262v52
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Interventions: Carboplatin (Drug), Docetaxel (Drug), Paclitaxel (Drug), Pembrolizumab (Biological), Sacituzumab Tirumotecan (Biological) to Carboplatin (Drug), Cisplatin (Drug), Docetaxel (Drug), Paclitaxel (Drug), Pembrolizumab (Biological), Sacituzumab Tirumotecan (Biological)v51
  2. Minor Study sites: 261 to 260v50
  3. Minor Site details revised at 1 of 261 sitesv49
  1. Minor Trial sites expanded: 253 → 261 locationsv48
  2. Minor Start date: May 21, 2025 to May 22, 2025 Study sites revised (253)v47 Show 1 more changeShow less
  3. Minor Study sites: 251 to 253 Start date: May 22, 2025 to May 21, 2025v46 Show 1 more changeShow less
    • Start date: May 22, 2025 to May 21, 2025
  4. Minor Study sites: 250 to 251v45
  5. Minor Study sites: 249 to 250v44
  6. Minor Study sites: 248 to 249v43
  7. Minor Trial sites expanded: 245 → 248 locationsv42
  8. Minor Study sites: 243 to 245v41
  9. Minor Study sites: 241 to 243v40
  10. Minor Study sites: 239 to 241v39
  11. Minor Trial sites expanded: 234 → 239 locationsv38
  12. Minor Study sites: 232 to 234v37
  13. Minor Study sites: 229 to 232v36
  14. Minor Study sites: 226 to 229v35
  15. Minor Study sites: 223 to 226v34
  16. Minor Study sites: 220 to 223 Eligibility criteria expanded, about 15 wordsv33 Show 1 more changeShow less
    • Eligibility criteria expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  17. Minor Study sites: 219 to 220v32
  18. Minor Study sites: 215 to 219v31
  19. Minor Study sites: 212 to 215v30
  20. Minor Study sites: 208 to 212v29
  21. Minor Study sites: 207 to 208v28
  22. Minor Study sites: 203 to 207v27
  23. Minor Study sites: 202 to 203v26
  24. Minor Study sites: 197 to 202v25
  25. Minor Study sites: 186 to 197v24
  26. Minor Study sites: 182 to 186v23
  27. Minor Study sites: 168 to 182v22
  28. Minor Study sites: 157 to 168v21
  29. Minor Study sites: 152 to 157v20
  30. Minor Study sites: 141 to 152v19
  31. Minor Study sites: 132 to 141v18
  32. Minor Study sites: 120 to 132v17
  33. Minor Study sites: 106 to 120v16
  34. Minor Study sites: 95 to 106v15
  35. Minor Study sites: 84 to 95v14
  36. Minor Study sites: 46 to 84v13
  37. Minor Study sites: 21 to 46v12
  38. Minor Study Identification, Study Status, Eligibilityv11
  39. Minor Study sites: 19 to 21v10
  40. Minor Study sites: 15 to 19v9
  41. Minor Study sites: 13 to 15v8
  42. Minor Study sites: 12 to 13v7
  • 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.
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.
Trial Details
NCT Number NCT06952504
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Endometrial Cancer
Enrollment 1,123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov