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Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving Vemurafenib (RO51...

Update Il y a 4 ans
Reference: EUCTR2009-012293-12

Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine

Woman and Man

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Extract

To evaluate the efficacy of RO5185426 as a monotherapy compared to dacarbazine in terms of progression free survival (PFS) and overall survival (OS) in previously untreated patients with advanced melanoma harbouring the BRAF V600E mutation.

Inclusion criteria

  • First-line therapy for adult patients with histologically confirmed metastatic melanoma (unresectable Stage IIIC or Stage IV) harbouring the V600E positive mutation

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