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You can access this
clinical trial
if you have
Melanoma
and you are
over 18
years old
Phase
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

This is a two-arm, open-label, randomised, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy to vemurafenib. Subjects with histologically confirmed cutaneous melanoma that is either stage IIIc (unresectable) or stage IV, and BRAF V600E/K mutation positive will be screened for eligibility. Subjects who have had prior systemic anti-cancer treatment in the advanced or metastatic setting will not be eligible although prior systemic treatment in the adjuvant setting will be allowed. Approximately 694 subjects will be randomised 1:1 (combination therapy:vemurafenib). The primary endpoint is overall survival (OS) for subjects receiving the combination therapy compared with those receiving vemurafenib.

Provided treatments

  • Drug: Dabrafenib
  • Drug: Vemurafenib
  • Drug: Trametinib
Tris trial is registered with FDA with number: NCT01597908. The sponsor of the trial is Novartis Pharmaceuticals and it is looking for 704 volunteers for the current phase.
Official trial title:
A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma