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Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 78 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Trial completed · Final enrollment: 263 participants (planned 370) · Primary and study completion dates changed from estimate of Aug 21, 2026 to Jul 23, 2026 · 4 more Show 7 more changesShow less
    • Trial completed
    • Final enrollment: 263 participants (planned 370)
    • Primary and study completion dates changed from estimate of Aug 21, 2026 to Jul 23, 2026
    • Interventions: Belzutifan (Drug), Favezelimab/Pembrolizumab (Biological), Lenvatinib (Drug), MK-4830 (Biological), Pembrolizumab (Biological)… to Belzutifan (Drug), Favezelimab/Pembrolizumab (Biological), Lenvatinib (Drug), MK-4830 (Biological), Pembrolizumab (Biological)…
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised at 3 of 51 sites
  2. Primary and study completion pushed from Jul 17, 2026 to Aug 21, 2026v77
  3. Primary and study completion dates: May 31, 2026 to Jul 17, 2026v76
  4. Study sites revised (51)v75 See this version in full on ClinicalTrials.gov ↗
  5. Primary and study completion dates: Sep 7, 2025 to May 31, 2026v74
Show 45 earlier versionsHide 45 earlier versions
  1. Eligibility criteria expanded, about 18 words Secondary endpoints: details revised at 1 of 4 entriesv73 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 4 entries

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since Jan 25, 2024, no change to tracked fieldsv71-v72
  3. Study Status, Outcome Measuresv70
  4. Trial status: Recruiting to Active, Not Recruiting Primary and study completion dates: Oct 31, 2025 to Sep 7, 2025 · Site details revised at 51 of 51 sitesv69 Show 2 more changesShow less
    • Primary and study completion dates: Oct 31, 2025 to Sep 7, 2025
    • Site details revised at 51 of 51 sites
  5. Site details revised at 3 of 51 sitesv68
  6. Study sites: 50 to 51v67
  7. Site details revised at 1 of 50 sitesv66
  8. Site details revised at 2 of 50 sitesv65
  9. Study sites: 48 to 50v64
  10. Study sites: 47 to 48v63
  11. Study sites: 46 to 47v62
  12. Study sites: 45 to 46v61
  13. Site details revised at 4 of 45 sitesv60
  14. Study sites: 43 to 45v59
  15. Site details revised at 1 of 43 sitesv58
  16. Study sites: 41 to 43v57
  17. Study sites: 40 to 41v56
  18. Study sites: 39 to 40v55
  19. Primary and study completion dates: May 29, 2025 to Oct 31, 2025v54
  20. Site details revised at 2 of 39 sitesv53
  21. Site details revised at 2 of 39 sitesv52
  22. Site details revised at 1 of 39 sitesv51
  23. Site details revised at 1 of 39 sitesv50
  24. Study sites: 38 to 39v49
  25. Site details revised at 1 of 38 sitesv48
  26. Site details revised at 1 of 38 sitesv47
  27. Study sites: 36 to 38v46
  28. Study sites: 35 to 36v45
  29. Site details revised at 2 of 35 sitesv44
  30. Study sites: 34 to 35v43
  31. Site details revised at 1 of 34 sitesv42
  32. Study sites: 32 to 34v41
  33. Site details revised at 1 of 32 sitesv40
  34. Site details revised at 1 of 32 sitesv39
  35. Site details revised at 1 of 32 sitesv38
  36. Site details revised at 2 of 32 sitesv37
  37. Site details revised at 1 of 32 sitesv36
  38. Site details revised at 1 of 32 sitesv35
  39. Study sites revised (32)v34 See this version in full on ClinicalTrials.gov ↗
  40. Site details revised at 1 of 32 sitesv33
  41. Site details revised at 1 of 32 sitesv32
  42. Site details revised at 1 of 32 sitesv31
  43. Study sites: 31 to 32v30
  44. Site details revised at 1 of 31 sitesv29
  • 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
Kidney Cancer
772 trials monitored
See 53 trials at risk
Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.
Trial Details
NCT Number NCT04626518
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Carcinoma, Renal Cell
Enrollment 263 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov