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Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Aug 2026 to Oct 29, 2025 Completion pushed from Aug 2026 to Dec 24, 2027v15 Show 1 more changeShow less
    • Completion pushed from Aug 2026 to Dec 24, 2027
  2. Re-verified, no change to tracked fieldsv14
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 60 to confirmed 67 · Site details revised at 3 of 3 sitesv13 Show 2 more changesShow less
    • Enrollment target: estimated 60 to confirmed 67
    • Site details revised at 3 of 3 sites
  4. Re-verified, no change to tracked fieldsv12
  5. Site details revised at 1 of 3 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 2 to 3v10
  2. Re-verified, no change to tracked fieldsv9
  3. Study sites: 1 to 2v8
  4. Eligibility criteria shortened, about 11 words Secondary endpoints: details revised at 1 of 3 entriesv7 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 3 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv6
  6. Trial status: Active, Not Recruiting to Recruiting Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  7. Trial status: Recruiting to Active, Not Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  8. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2020 to Jan 1, 2020 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2020 to Jan 1, 2020
    • Site details revised
  9. Start date: Aug 2019 to Jan 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.
Trial Details
NCT Number NCT04013854
Lead Sponsor Abramson Cancer Center at Penn Medicine
Conditions Melanoma Stage III, Melanoma
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov