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Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

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

Record History

The 50 most recent of 83 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 · Enrollment target: estimated 400 to confirmed 393 · Primary and study completion dates changed from estimate of Aug 21, 2026 to Aug 10, 2026 · 4 more Show 7 more changesShow less
    • Trial completed
    • Enrollment target: estimated 400 to confirmed 393
    • Primary and study completion dates changed from estimate of Aug 21, 2026 to Aug 10, 2026
    • Interventions: Belzutifan (Drug), Favezelimab/Pembrolizumab (Biological), Lenvatinib (Drug), Pembrolizumab (Biological), Pembrolizumab/Quavonlimab… to Belzutifan (Drug), Favezelimab/Pembrolizumab (Biological), Lenvatinib (Drug), Pembrolizumab (Biological), Pembrolizumab/Quavonlimab…
    • Eligibility criteria expanded, about 27 words
    • Site details revised at 3 of 55 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion pushed from Jul 17, 2026 to Aug 21, 2026v82
  3. Study sites revised (55)v81 See this version in full on ClinicalTrials.gov ↗
  4. Primary and study completion pushed from May 31, 2026 to Jul 17, 2026v80
  5. Study Identification, Study Status, IPDSharing, Referencesv79
Show 45 earlier versionsHide 45 earlier versions
  1. 2 versions Re-verified since Nov 14, 2024, no change to tracked fieldsv77-v78
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 55 of 55 sitesv76 Show 1 more changeShow less
    • Site details revised at 55 of 55 sites
  3. Site details revised at 3 of 55 sitesv75
  4. Site contacts updated at 1 of 55 sitesv74
  5. Site details revised at 3 of 55 sitesv73
  6. Site details revised at 1 of 55 sitesv72
  7. Site details revised at 2 of 55 sitesv71
  8. Re-verified, no change to tracked fieldsv70
  9. Site details revised at 1 of 55 sitesv69
  10. Site details revised at 1 of 55 sitesv68
  11. Site details revised at 1 of 55 sitesv67
  12. Site details revised at 1 of 55 sitesv66
  13. Site details revised at 1 of 55 sitesv65
  14. Site details revised at 1 of 55 sitesv64
  15. Study sites revised (55)v63 See this version in full on ClinicalTrials.gov ↗
  16. Site details revised at 1 of 55 sitesv62
  17. Site details revised at 1 of 55 sitesv61
  18. Study sites: 53 to 55v60
  19. Study sites: 52 to 53v59
  20. Site details revised at 1 of 52 sitesv58
  21. Study sites: 50 to 52v57
  22. Study sites: 49 to 50v56
  23. Study sites: 48 to 49v55
  24. Study sites: 45 to 48v54
  25. Study sites: 43 to 45v53
  26. Site details revised at 1 of 43 sitesv52
  27. Study sites: 41 to 43v51
  28. Study sites: 38 to 41v50
  29. Primary and study completion dates: Mar 16, 2026 to May 31, 2026 Site details revised at 1 of 38 sitesv49 Show 1 more changeShow less
    • Site details revised at 1 of 38 sites
  30. Site details revised at 2 of 38 sitesv48
  31. Site details revised at 2 of 38 sitesv47
  32. Site details revised at 1 of 38 sitesv46
  33. Site details revised at 1 of 38 sitesv45
  34. Study sites: 37 to 38v44
  35. Study sites: 36 to 37v43
  36. Study sites: 35 to 36v42
  37. Study sites: 34 to 35v41
  38. Site details revised at 2 of 34 sitesv40
  39. Study sites: 33 to 34v39
  40. Site details revised at 1 of 33 sitesv38
  41. Study sites: 31 to 33v37
  42. Enrollment target: 390 to 400 Interventions: Belzutifan (Drug), Favezelimab/Pembrolizumab (Biological), Lenvatinib (Drug), Pembrolizumab (Biological), Pembrolizumab/Quavonlimab… to Belzutifan (Drug), Favezelimab/Pembrolizumab (Biological), Lenvatinib (Drug), Pembrolizumab (Biological), Pembrolizumab/Quavonlimab… · Site details revised at 1 of 31 sites · Study arms: 4 to 5v36 Show 3 more changesShow less
    • Interventions: Belzutifan (Drug), Favezelimab/Pembrolizumab (Biological), Lenvatinib (Drug), Pembrolizumab (Biological), Pembrolizumab/Quavonlimab… to Belzutifan (Drug), Favezelimab/Pembrolizumab (Biological), Lenvatinib (Drug), Pembrolizumab (Biological), Pembrolizumab/Quavonlimab…
    • Site details revised at 1 of 31 sites
    • Study arms: 4 to 5
  43. Site details revised at 3 of 31 sitesv35
  44. Primary and study completion dates: Jun 11, 2025 to Mar 16, 2026v34
  • 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 03A 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 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) 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 NCT04626479
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Carcinoma, Renal Cell
Enrollment 393 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov