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Trial Summary

This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis.

Acronym:

ARRAY MELANOMA

ACTRN/NCT /ethics:

NCT03911869

Scientific title:

An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

Sponsor / Cooperative group:

Array BioPharma

Trial & Patient Characteristics

Cancer TypeMelanoma & other skin
Trial TypeTreatment
PhasePhase II
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2019-06-13
Anticipated End Date-

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlex Scott-Hoy
Emailalex.scott-hoy@sa.gov.au
Phone08 8204 4830
Principal InvestigatorDr Amitesh Roy
Recruitment StatusRecruiting