A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

Study acronym: TroFuse-015
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Show 5 more changesShow less
    • Primary completion date changed from estimate of Jan 4, 2027 to Oct 19, 2026
    • Enrollment target: estimated 450 to confirmed 473
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 15 of 168 sites
  2. Interventions: Docetaxel (Drug), Irinotecan (Drug), Paclitaxel (Drug), Rescue medication (Drug), Sacituzumab tirumotecan (Biological), Supportive care… to Docetaxel (Drug), Irinotecan (Drug), Paclitaxel (Drug), Rescue medications (Drug), Sacituzumab tirumotecan (Biological), Supportive care…
    • Eligibility criteria shortened, about 7 words
    v48
  3. Re-verified, no change to tracked fieldsv47
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 168 of 168 sites
    v46
  5. Site details revised at 68 of 168 sitesv45
Show 43 earlier versionsHide 43 earlier versions
  1. Site details revised at 14 of 168 sitesv44
  2. Site details revised at 9 of 168 sitesv43
  3. Site details revised at 5 of 168 sitesv42
  4. Site details revised at 4 of 168 sitesv41
  5. Site details revised at 6 of 168 sitesv40
  6. Site details revised at 6 of 168 sitesv39
  7. Study sites revised (168)v38
  8. Site contacts updated at 2 of 168 sitesv37
  9. Study sites: 166 to 168
    • Eligibility criteria shortened, about 22 words
    • Secondary endpoints: details revised at 3 of 5 entries
    v36
  10. Study completion date: May 5, 2028 to May 6, 2027
    • Study sites revised (166)
    v35
  11. Site details revised at 11 of 166 sitesv34
  12. Site details revised at 28 of 166 sitesv33
  13. Study sites: 162 to 166
    • Eligibility criteria expanded, about 1 word
    v32
  14. Study sites: 153 to 162v31
  15. Study sites: 151 to 153v30
  16. Study sites: 143 to 151v29
  17. Study sites: 138 to 143v28
  18. Study sites: 134 to 138v27
  19. Study sites: 129 to 134
    • Eligibility criteria expanded, about 61 words
    v26
  20. Study sites: 127 to 129v25
  21. Study sites: 114 to 127v24
  22. Study sites: 110 to 114v23
  23. Study sites: 106 to 110v22
  24. Study sites: 102 to 106v21
  25. Study sites: 93 to 102v20
  26. Study sites: 79 to 93v19
  27. Study sites: 61 to 79v18
  28. Study sites: 42 to 61v17
  29. Study sites: 31 to 42v16
  30. Study sites: 30 to 31v15
  31. Study sites: 29 to 30v14
  32. Study sites: 28 to 29v13
  33. Study sites: 27 to 28v12
  34. Study sites: 22 to 27
    • Interventions: Docetaxel (Drug), Irinotecan (Drug), Paclitaxel (Drug), Sacituzumab tirumotecan (Biological), Trifluridine-Tipiracil (Drug) to Docetaxel (Drug), Irinotecan (Drug), Paclitaxel (Drug), Rescue medication (Drug), Sacituzumab tirumotecan (Biological), Supportive care…
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: details revised at 3 of 5 entries
    v11
  35. Study sites: 17 to 22v10
  36. Study sites: 14 to 17v9
  37. Study sites: 10 to 14v8
  38. Study sites: 9 to 10v7
  39. Study sites: 5 to 9v6
  40. Study sites: 3 to 5v5
  41. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of May 8, 2024 to May 3, 2024
    v4
  42. Re-verified, no change to tracked fieldsv3
  43. Interventions: Docetaxel (Drug), Irinotecan (Drug), MK-2870 (Biological), Paclitaxel (Drug), Trifluridine-Tipiracil (Drug) to Docetaxel (Drug), Irinotecan (Drug), Paclitaxel (Drug), Sacituzumab tirumotecan (Biological), Trifluridine-Tipiracil (Drug)
    • Eligibility criteria expanded, about 2 words
    • Study title expanded, about 2 words
    v2
  1. Study First Submitted
  • 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)
412 trials monitored
See 25 trials at risk
Esophageal Cancer
1,056 trials monitored
See 54 trials at risk
This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).
Trial Details
NCT Number NCT06356311
Lead Sponsor Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Gastroesophageal Cancer
Related terms Adenocarcinoma Of Esophagus
Enrollment 473 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov