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Clinical Trial VICCMEL1398

Title

BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation- Positive Melanoma that has Metastasized to the Brain

Principal Investigator(s)

Igor Puzanov

Details

  • Protocol No. VICCMEL1398
  • Open Date: 05/23/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To assess the intracranial response (IR) of subjects with centrally confirmed BRAF V600E-mutation positive melanoma that has metastasized to the brain without symptoms and have not undergone prior local therapy for brain metastases (Cohort A).
  • Disease Sites: Neuro-Oncology; Melanoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Dabrafenib; Trametinib
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02039947
  • Secondary Protocol No: BRF117277

Description

Participants are being asked to take part in this study because they have been diagnosed with melanoma with metastases to the brain. The purpose of this study is to evaluate the safety and how well the combination of dabrafenib and trametinib works in patients with melanoma with metastases to the brain.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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.