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A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Spartalizumab (Primary) ; Dabrafenib; Trametinib
  • Indications Malignant melanoma
  • Focus Adverse reactions; Biomarker; Registrational; Therapeutic Use
  • Acronyms COMBI-i
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 29 Apr 2025 Status changed to discontinued.
  • 03 Oct 2024 This trial has been completed in Poland, according to European Clinical Trials Database record.
  • 31 Aug 2024 This trial has been completed in Czechia according to European Clinical Trials Database record.

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