Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
NCT ID: NCT05868629
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2024-02-06
2028-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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dabrafenib plus trametinib
patients treated with dabrafenib and trametinib
Non-investigational
Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program
Interventions
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Non-investigational
Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program
Eligibility Criteria
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Inclusion Criteria
* 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
* Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;
1 Year
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Lundquist Inst BioMed at Harbor
Torrance, California, United States
Johns Hopkins University
Washington D.C., District of Columbia, United States
Duke Clinical Research Institute
Durham, North Carolina, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
El Paso Texas Oncology
El Paso, Texas, United States
Texas Oncology San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Other Identifiers
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CDRB436IIC01
Identifier Type: -
Identifier Source: org_study_id