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Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 15, 2026 → Nov 20, 2026
See other at-risk trials from Merck (MSD)

Record History

The 50 most recent of 82 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Primary and study completion pushed from Sep 15, 2026 to Nov 20, 2026 · Site details revised at 10 of 231 sites · Publications: details revised at 2 of 2 entries Show 3 more changesShow less
    • Primary and study completion pushed from Sep 15, 2026 to Nov 20, 2026
    • Site details revised at 10 of 231 sites
    • Publications: details revised at 2 of 2 entries
  2. Study sites revised (231)v81 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (231)v80 See this version in full on ClinicalTrials.gov ↗
  4. Primary and study completion dates: May 31, 2026 to Sep 15, 2026v79
  5. Primary and study completion dates: Jun 18, 2025 to May 31, 2026v78
Show 45 earlier versionsHide 45 earlier versions
  1. Publications: details revised at 1 of 2 entriesv77
  2. Re-verified, no change to tracked fieldsv76
  3. Study Identification, Study Status, Referencesv75
  4. Re-verified, no change to tracked fieldsv74
  5. Trial status: Recruiting to Active, Not Recruiting Site details revised at 231 of 231 sitesv73 Show 1 more changeShow less
    • Site details revised at 231 of 231 sites
  6. Study sites revised (231)v72 See this version in full on ClinicalTrials.gov ↗
  7. Study sites: 230 to 231v71
  8. Study sites revised (230)v70 See this version in full on ClinicalTrials.gov ↗
  9. Site details revised at 6 of 230 sitesv69
  10. Study sites: 229 to 230v68
  11. Site details revised at 2 of 229 sitesv67
  12. Study sites: 227 to 229v66
  13. Study sites: 226 to 227v65
  14. Study sites: 223 to 226v64
  15. Study sites: 222 to 223v63
  16. Study sites: 221 to 222v62
  17. Site details revised at 6 of 221 sitesv61
  18. Study sites: 220 to 221v60
  19. Study sites: 219 to 220v59
  20. Study sites: 218 to 219v58
  21. Study sites: 217 to 218v57
  22. Study sites: 216 to 217v56
  23. Site details revised at 21 of 216 sitesv55
  24. Study sites: 215 to 216v54
  25. Study sites: 213 to 215v53
  26. Study sites: 211 to 213v52
  27. Study sites: 208 to 211v51
  28. Study sites: 207 to 208v50
  29. Study sites: 205 to 207v49
  30. Study sites: 203 to 205v48
  31. Study sites: 201 to 203v47
  32. Study sites: 200 to 201v46
  33. Study sites: 199 to 200v45
  34. Study sites: 190 to 199v44
  35. Study sites: 188 to 190v43
  36. Study sites: 185 to 188v42
  37. Study sites: 183 to 185v41
  38. Study sites: 178 to 183v40
  39. Study sites: 170 to 178v39
  40. Study sites: 167 to 170v38
  41. Study sites: 162 to 167v37
  42. Study sites: 161 to 162v36
  43. Study sites: 156 to 161v35
  44. Study sites: 152 to 156v34
  45. Study sites: 149 to 152v33
  • 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.
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
Trial Details
NCT Number NCT04634877
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group
Conditions Endometrial Neoplasms
Enrollment 990 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov