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A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma

Study acronym: Neo PeLe
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study description revisedv15 See this version in full on ClinicalTrials.gov ↗
  2. Secondary endpoints: details revised at 3 of 20 entriesv14
  3. Re-verified, no change to tracked fieldsv13
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 40 to confirmed 21 · Primary completion date changed from estimate of Jan 1, 2024 to Jan 31, 2023 · Site details revisedv12 Show 3 more changesShow less
    • Enrollment target: estimated 40 to confirmed 21
    • Primary completion date changed from estimate of Jan 1, 2024 to Jan 31, 2023
    • Site details revised
  5. Primary completion date: Jan 1, 2023 to Jan 1, 2024v11
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Jul 1, 2023 to Jan 1, 2023 · Completion date: Mar 1, 2025 to Jan 1, 2033 · Site details revisedv10 Show 3 more changesShow less
    • Primary completion date: Jul 1, 2023 to Jan 1, 2023
    • Completion date: Mar 1, 2025 to Jan 1, 2033
    • Site details revised
  2. Primary completion date: Jul 1, 2022 to Jul 1, 2023 Completion date: Mar 1, 2024 to Mar 1, 2025v9 Show 1 more changeShow less
    • Completion date: Mar 1, 2024 to Mar 1, 2025
  3. Enrollment target: 20 to 40v8
  4. Primary completion date: Nov 1, 2021 to Jul 1, 2022 Trial status: Recruiting to Active, Not Recruiting · Site details revisedv7 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
  5. Primary completion date: Mar 1, 2021 to Nov 1, 2021v6
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 1, 2020 to Nov 11, 2020 · Site details revisedv5 Show 2 more changesShow less
    • Start date changed from estimate of Sep 1, 2020 to Nov 11, 2020
    • Site details revised
  7. Start date: Aug 1, 2020 to Sep 1, 2020v4
  8. Start date: Mar 1, 2020 to Aug 1, 2020v3
  9. Enrollment target: 2 to 20v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In many cancers, early stage diagnosis and early treatment offers the best chance of a prolonged recurrence free- and overall survival. In stage III/IV resectable melanoma, an opportunity exists to improve outcomes with the addition of neoadjuvant and adjuvant systemic therapy as an adjunct to surgery. Neoadjuvant clinical trials for resectable but bulky stage III/IV melanoma allows for the efficient and rapid evaluation of drug activity in humans utilising multiple clinical endpoints of metabolic, radiological and pathological response; relapse-free survival; overall survival.
Trial Details
NCT Number NCT04207086
Lead Sponsor Melanoma Institute Australia
Collaborators: Merck Sharp & Dohme LLC
Conditions Melanoma Stage III
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov