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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)

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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: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2024

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At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary)
  • Indications Malignant melanoma; Skin cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms COMBI-APlus
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

    • Most Recent Events

    • 31 Jan 2024 This trial has been Completed in Portugal, According to European Clinical Trials Database record.
    • 13 Sep 2022 Results of an analysis reporting patient-reported outcomes during 12-month adjuvant dabrafenib plus trametinib treatment presented at the 47th European Society for Medical Oncology Congress
    • 13 Sep 2022 Results (N=552; At data cut-off (18 Nov 2021) assessing safety and efficacy of adjuvant dabrafenib plus trametinib in patients with resected stage III BRAF V600E/K-mutant melanoma presented at the 47th European Society for Medical Oncology Congress

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