Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05484622 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 72 to confirmed 60 · Primary completion date changed from estimate of Jan 31, 2026 to Feb 12, 2026 · Site details revised at 17 of 17 sitesv22 Show 3 more changesShow less
    • Enrollment target: estimated 72 to confirmed 60
    • Primary completion date changed from estimate of Jan 31, 2026 to Feb 12, 2026
    • Site details revised at 17 of 17 sites
  2. Site contacts updated at 1 of 17 sitesv21
  3. Primary completion date: Mar 31, 2025 to Jan 31, 2026 Study sites: 16 to 17v20 Show 1 more changeShow less
    • Study sites: 16 to 17
  4. Eligibility criteria revisedv19 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 14 to 16 Eligibility criteria expanded, about 53 words · Study title shortened, about 1 wordv18 Show 2 more changesShow less
    • Eligibility criteria expanded, about 53 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 12 to 14v17
  2. Study sites: 10 to 12v16
  3. Study Status, Referencesv15
  4. Study sites: 9 to 10 Primary completion date: Feb 28, 2025 to Mar 31, 2025v14 Show 1 more changeShow less
    • Primary completion date: Feb 28, 2025 to Mar 31, 2025
  5. Primary completion date: Mar 28, 2024 to Feb 28, 2025v13
  6. Eligibility criteria expanded, about 25 words Secondary endpoints: 6 to 7 · Study title revisedv12 Show 2 more changesShow less
    • Secondary endpoints: 6 to 7
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  7. Site contacts updated at 1 of 9 sitesv11
  8. Study sites revised (9)v10 See this version in full on ClinicalTrials.gov ↗
  9. Eligibility criteria expanded, about 12 words Site details revised at 2 of 9 sitesv9 Show 1 more changeShow less
    • Site details revised at 2 of 9 sites

    See this version in full on ClinicalTrials.gov ↗

  10. Start date: Feb 20, 2023 to Jan 20, 2023v8
  11. Re-verified, no change to tracked fieldsv7
  12. Site details revised at 1 of 9 sitesv6
  13. Site details revised at 1 of 9 sitesv5
  14. Start date changed from estimate of Dec 30, 2022 to Feb 20, 2023 Site details revised at 3 of 9 sitesv4 Show 1 more changeShow less
    • Site details revised at 3 of 9 sites
  15. Start date: Nov 30, 2022 to Dec 30, 2022 Site details revised at 1 of 9 sitesv3 Show 1 more changeShow less
    • Site details revised at 1 of 9 sites
  16. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 15, 2022 to Nov 30, 2022 · Study sites: 0 to 9v2 Show 2 more changesShow less
    • Start date: Aug 15, 2022 to Nov 30, 2022
    • Study sites: 0 to 9
  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.
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
Trial Details
NCT Number NCT05484622
Lead Sponsor Institut de Recherches Internationales Servier
Collaborators: Merck Sharp & Dohme LLC
Conditions Astrocytoma, Oligodendroglioma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov