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COMBI-APlus: Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm (Plus)

Trial Profile

COMBI-APlus: Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm (Plus)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Oct 2019

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At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary)
  • Indications Malignant melanoma
  • Focus Adverse reactions; Registrational
  • Acronyms COMBI-APlus
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals
  • Most Recent Events

    • 21 Aug 2019 Trial has been suspended in Finland, according to European Clinical Trials Database record.
    • 31 Jul 2019 Trial has been suspended in Latvia, according to European Clinical Trials Database record.
    • 13 Sep 2018 Planned End Date changed from 25 Aug 2021 to 22 Oct 2021.
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