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Neoadjuvant PD-1 Blockade in Patients With Stage IIB/C Melanoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 1, 2024 → Nov 13, 2025
See other at-risk trials from Abramson Cancer Center at Penn Medicine

Record History

  1. Primary completion pushed from Dec 1, 2024 to Nov 13, 2025 Final enrollment: 86 participants (planned 63) · Completion date: Feb 2027 to Feb 1, 2027 · Eligibility criteria expanded, about 52 words · 1 more Show 4 more changesShow less
    • Final enrollment: 86 participants (planned 63)
    • Completion date: Feb 2027 to Feb 1, 2027
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Primary completion date changed from estimate of Dec 2024 to Dec 1, 2024 Completion date: Feb 2026 to Feb 2027v14 Show 1 more changeShow less
    • Completion date: Feb 2026 to Feb 2027
  3. Trial status: Recruiting to Active, Not Recruiting Start date: Jul 1, 2019 to May 6, 2019 · Site details revised at 3 of 3 sitesv13 Show 2 more changesShow less
    • Start date: Jul 1, 2019 to May 6, 2019
    • Site details revised at 3 of 3 sites
  4. Study sites: 2 to 3v12
  5. Study sites: 1 to 2v11
Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Primary completion date: Apr 2022 to Dec 2024v9
  3. Start date: Feb 19, 2019 to Jul 1, 2019v8
  4. Re-verified, no change to tracked fieldsv7
  5. Primary completion date: Apr 2021 to Apr 2022v6
  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. Re-verified, no change to tracked fieldsv3
  9. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2019 to Feb 19, 2019 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2019 to Feb 19, 2019
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main purpose of this study is to determine the rate of positive sentinel lymph nodes (i.e. the closest draining lymph node(s) to the primary melanoma site) and to test whether treatment with pembrolizumab before surgery to remove melanoma reduces the rate of positive sentinel lymph nodes in patients with Stage IIB/C melanoma. Subjects with stage II melanoma will receive one dose of pembrolizumab 200 mg, then undergo standard definitive surgery with wide excision and sentinel lymph node (SLN) biopsy approximately 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.
Trial Details
NCT Number NCT03757689
Lead Sponsor Abramson Cancer Center at Penn Medicine
Conditions Melanoma
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov