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A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later across 2 updates Jul 21, 2026 → Oct 22, 2026
See other at-risk trials from Merck (MSD)

Record History

  1. Primary and study completion pushed from Sep 22, 2026 to Oct 22, 2026v23
  2. Primary and study completion pushed from Jul 21, 2026 to Sep 22, 2026v22
  3. Enrollment target: 210 to 60 Primary endpoints: 4 to 3 · Secondary endpoints shortened, about 100 words · Study arms: 5 to 3v21 Show 3 more changesShow less
    • Primary endpoints: 4 to 3
    • Secondary endpoints shortened, about 100 words
    • Study arms: 5 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Primary and study completion dates: Sep 16, 2028 to Jul 21, 2026 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 13 of 13 sitesv20 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 13 of 13 sites
  5. Site contacts updated at 2 of 13 sitesv19
Show 17 earlier versionsHide 17 earlier versions
  1. Site contacts updated at 1 of 13 sitesv18
  2. Site contacts updated at 2 of 13 sitesv17
  3. Site contacts updated at 2 of 13 sitesv16
  4. Study sites: 12 to 13v15
  5. Study sites: 11 to 12v14
  6. Study sites: 10 to 11v13
  7. Study sites: 9 to 10v12
  8. Study sites: 5 to 9v11
  9. Enrollment target: 180 to 210 Secondary endpoints: details revised at 6 of 6 entriesv10 Show 1 more changeShow less
    • Secondary endpoints: details revised at 6 of 6 entries
  10. Primary and study completion dates: Mar 16, 2027 to Sep 16, 2028v9
  11. Re-verified, no change to tracked fieldsv8
  12. Site details revised at 1 of 5 sitesv7
  13. Study sites: 4 to 5v6
  14. Study sites: 3 to 4 Study title revisedv5 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 2 to 3v4
  16. Start date changed from estimate of Aug 22, 2022 to Aug 10, 2022v3
  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date: Aug 3, 2022 to Aug 22, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date: Aug 3, 2022 to Aug 22, 2022
  1. Study First Submitted
  • 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
The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on or after receiving prior therapy. The study will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by ascending dose escalation.
Trial Details
NCT Number NCT05468697
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Renal Cell Carcinoma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov