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Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Recruitingn/aAges 1 Year - 100 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test; * At least 1 measurable lesion as defined by RECIST v1.1 per local review; * Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year; * Ability to provide scans for central imaging review Exclusion Criteria: * Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC; * Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;
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What it tests

  • Non-investigational
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Where

8 sites
Lundquist Inst BioMed at Harbor
Torrance, United States
Rocky Mountain Cancer Centers
Denver, United States
Johns Hopkins University
Washington D.C., United States
Duke Clinical Research Institute
Durham, United States
Oncology Hematology Care Inc
Cincinnati, United States
Sarah Cannon Research Institute
Nashville, United States
El Paso Texas Oncology
El Paso, United States
Texas Oncology San Antonio
San Antonio, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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