Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

• Status: Completed
• Trial end date: 2018-02-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline; Novartis Pharmaceuticals
• Treatments: Dabrafenib; Trametinib

Criteria

Inclusion Criteria:

• ECOG Performance Status range of 0-2

• Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.

• May be systemic naïve or received up to two previous systemic treatment regimens for metastatic melanoma.

• Must be able to undergo MRI and have at least one measurable intracranial lesion for which specific criteria have to be met.

Exclusion Criteria:

• Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular signal-regulated kinase inhibitor.

• Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe.

• Treatment with stereotactic radiosurgery or treatment with whole-brain radiation within treatment specific timeframe.

• Any presence of leptomeningeal disease or any parenchymal brain metastasis

• History of another malignancy, some exceptions may apply.

• A history or evidence of cardiovascular risk- specific criteria have to be met

• A history or current evidence/risk of retinal vein occlusion or retinal pigment epithelial detachment - specific criteria have to be met.