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An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Primary and study completion dates: Nov 30, 2032 to Nov 21, 2032v18
  2. Notable Primary and study completion dates: Sep 9, 2029 to Nov 30, 2032
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 22 to 23
    v17
  3. Minor Secondary endpoints: details revised at 3 of 3 entriesv16
  4. Minor Site contacts updated at 4 of 22 sitesv15
  5. Minor Study sites: 21 to 22v14
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  1. Minor Enrollment target: 257 to 267v13
  2. Minor Study sites: 22 to 21v12
  3. Notable Trial status: Active, Not Recruiting to Recruitingv11 Show 5 more changesShow less
    • Enrollment target: 157 to 257
    • Primary and study completion dates: Sep 29, 2024 to Sep 9, 2029
    • Interventions: Pembrolizumab (Biological), mRNA-4157 (Biological) to Pembrolizumab (Biological), mRNA-4157 (Drug)
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised at 22 of 22 sites
  4. Notable Primary completion date: Jun 30, 2022 to Sep 29, 2024
    • Study completion date: Jun 30, 2024 to Sep 29, 2024
    v10
  5. Minor Re-verified, no change to tracked fieldsv9
  6. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 150 to confirmed 157
    • Site details revised at 22 of 22 sites
    v8
  7. Minor Re-verified, no change to tracked fieldsv7
  8. Notable Primary endpoint revised
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 4 to 3
    • Study title revised
    v6
  9. Notable Primary completion date: Dec 2021 to Jun 30, 2022
    • Study sites: 16 to 22
    • Study completion date: Dec 2023 to Jun 30, 2024
    v5
  10. Minor Study sites: 17 to 16v4
  11. Minor Site details revised at 1 of 17 sitesv3
  12. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 17
    • Start date changed from estimate of Jul 2019 to Jul 18, 2019
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.
Trial Details
NCT Number NCT03897881
Lead Sponsor ModernaTX, Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)
Melanoma
Related terms Melanoma
Enrollment 267 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov