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A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma

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

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 30 to confirmed 23 · Primary completion date: Jan 2028 to Jan 31, 2028 · Completion date: Dec 2029 to Dec 31, 2029 · 1 morev18 Show 4 more changesShow less
    • Enrollment target: estimated 30 to confirmed 23
    • Primary completion date: Jan 2028 to Jan 31, 2028
    • Completion date: Dec 2029 to Dec 31, 2029
    • Site details revised
  2. Primary completion date: Jan 2027 to Jan 2028 Completion date: Dec 2028 to Dec 2029v17 Show 1 more changeShow less
    • Completion date: Dec 2028 to Dec 2029
  3. Primary completion date: Jan 2026 to Jan 2027 Completion date: Dec 2027 to Dec 2028v16 Show 1 more changeShow less
    • Completion date: Dec 2027 to Dec 2028
  4. Start date: Dec 6, 2017 to Feb 7, 2018 Primary completion date: Jan 2027 to Jan 2026 · Completion date: Dec 2028 to Dec 2027v15 Show 2 more changesShow less
    • Primary completion date: Jan 2027 to Jan 2026
    • Completion date: Dec 2028 to Dec 2027
  5. Re-verified, no change to tracked fieldsv14
Show 12 earlier versionsHide 12 earlier versions
  1. Study description expanded, about 42 wordsv13 See this version in full on ClinicalTrials.gov ↗
  2. Study description expanded, about 4 wordsv12 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv11
  4. Eligibility criteria expanded, about 52 wordsv10 See this version in full on ClinicalTrials.gov ↗
  5. Eligibility criteria expanded, about 37 wordsv9 See this version in full on ClinicalTrials.gov ↗
  6. Eligibility criteria shortened, about 30 wordsv8 See this version in full on ClinicalTrials.gov ↗
  7. Eligibility criteria expanded, about 21 wordsv7 See this version in full on ClinicalTrials.gov ↗
  8. Eligibility criteria expanded, about 29 wordsv6 See this version in full on ClinicalTrials.gov ↗
  9. Eligibility criteria expanded, about 3 wordsv5 See this version in full on ClinicalTrials.gov ↗
  10. Eligibility criteria expanded, about 29 wordsv4 See this version in full on ClinicalTrials.gov ↗
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 2017 to Dec 6, 2017v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2017 to Dec 6, 2017
  12. Start date: Oct 2017 to Dec 2017 Secondary endpoints revised (6)v2 Show 1 more changeShow less
    • Secondary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

  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.
Yana Najjar
6 trials monitored
See 1 trial at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
The purpose of this study is to evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.
Trial Details
NCT Number NCT03311308
Lead Sponsor Yana Najjar
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced Melanoma
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov