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Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 322 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 20 of 782 sites
  2. Study sites revised (782)
  3. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Site details revised at 61 of 782 sites Show 1 more changeShow less
    • Site details revised at 61 of 782 sites
  4. Site details revised at 7 of 782 sitesv319
  5. Study sites revised (782)v318 See this version in full on ClinicalTrials.gov ↗
  6. Site details revised at 5 of 782 sitesv317
  7. Trial sites expanded: 776 → 782 locationsv316
  8. Trial sites reduced: 780 → 776 locationsv315
  9. Study sites: 781 to 780v314
  10. Site details revised at 3 of 781 sitesv313
  11. Study sites revised (781)v312 See this version in full on ClinicalTrials.gov ↗
  12. Site details revised at 14 of 781 sitesv311
  13. Study sites: 782 to 781v310
  14. Site details revised at 3 of 782 sitesv309
  15. Study sites revised (782)v308 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (782)v307 See this version in full on ClinicalTrials.gov ↗
  17. Site details revised at 4 of 782 sitesv306
  18. Study sites: 781 to 782v305
  19. Study sites: 780 to 781v304
  20. Site details revised at 79 of 780 sitesv303
  21. Study sites: 779 to 780v302
  22. Study sites: 777 to 779v301
  23. Site details revised at 12 of 777 sitesv300
  24. Trial arms changed: 15 → 17 Study sites: 776 to 777 · Interventions: Lenvatinib (Drug), MK-4280 (Drug), MK-4280A (Biological), Olaparib (Drug), Pembrolizumab (Drug), Standard of Care (SOC) (Drug) to Lenvatinib (Drug), MK-4280 (Drug), MK-4280A (Biological), Olaparib (Drug), Pembrolizumab (+) Berahyaluronidase alfa (Biological)…v299 Show 2 more changesShow less
    • Study sites: 776 to 777
    • Interventions: Lenvatinib (Drug), MK-4280 (Drug), MK-4280A (Biological), Olaparib (Drug), Pembrolizumab (Drug), Standard of Care (SOC) (Drug) to Lenvatinib (Drug), MK-4280 (Drug), MK-4280A (Biological), Olaparib (Drug), Pembrolizumab (+) Berahyaluronidase alfa (Biological)…
  25. Study sites: 775 to 776v298
  26. Study sites: 774 to 775v297
  27. Study sites: 773 to 774v296
  28. Study sites: 772 to 773v295
  29. Study sites: 763 to 772v294
  30. Study sites: 752 to 763v293
  31. Study sites: 747 to 752v292
  32. Study sites: 729 to 747v291
  33. Study sites: 724 to 729v290
  34. Study sites: 719 to 724v289
  35. Study sites: 713 to 719v288
  36. Study sites: 709 to 713v287
  37. Study sites: 696 to 709v286
  38. Study sites: 692 to 696v285
  39. Study sites: 684 to 692v284
  40. Study sites: 676 to 684v283
  41. Study sites: 675 to 676v282
  42. Study sites: 672 to 675v281
  43. Study sites: 670 to 672v280
  44. Study sites: 668 to 670v279
  45. Study sites: 667 to 668v278
  46. Study sites: 666 to 667v277
  47. Study sites: 664 to 666v276
  48. Study sites: 661 to 664v275
  49. Study sites: 660 to 661v274
  50. Study sites: 659 to 660v273
  • 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
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.
Trial Details
NCT Number NCT03486873
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Solid Tumors, Hematologic Malignancies
Enrollment 3,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov