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

Completed · Phase 2

Conditions studied: Melanoma and Brain Metastases

In brief

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.

Key facts

Study ID

NCT02039947

Run by

Novartis Pharmaceuticals

People needed

127

Starts

2014-02-21

Expected to finish

2018-02-14

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Chapel Hill, North Carolina, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — North Sydney, New South Wales, Australia
• Novartis Investigative Site — Greenslopes, Queensland, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Hamilton, Ontario, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Boulogne-Billancourt, France
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Pierre-Bénite, France

Full record on ClinicalTrials.gov

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