Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma

PHASE2UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 8, 2017

Primary Completion Date

January 2, 2022

Study Completion Date

November 30, 2024

Conditions
Melanoma
Interventions
DRUG

Dabrafenib

Dabrafenib, a 4-(3-aminosulfonylphenyl)-5-(pyrimidine-3-yl) thiazole, is a potent and selective inhibitor of B-RAF kinase activity with a mode of action consistent with adenosine triphosphate (ATP)-competitive inhibition, and is approved as monotherapy in BRAF V600E-mutant advanced/metastatic melanoma.

DRUG

Trametinib

Trametinib, a pyrido - pyrimidine derivative, is a potent and highly selective allosteric non-competitive inhibitor of MEK1/MEK2 activation and kinase activity has been approved as monotherapy in BRAF (V600E)-mutant and BRAF (V600K)-mutant melanoma.

DRUG

Pembrolizumab

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Trial Locations (3)

2065

Melanoma Institute Australia, Wollstonecraft

2145

Westmead Hospital, Sydney

3000

Peter MacCallum Cancer Centre, Melbourne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

Melanoma Institute Australia

OTHER

NCT02858921 - Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma | Biotech Hunter | Biotech Hunter