Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
NCT ID: NCT05806268
Last Updated: 2023-04-10
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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COMPLETED
214 participants
OBSERVATIONAL
2021-07-30
2022-03-28
Brief Summary
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No quota of centers was established a priori. Given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the NOBLE dataset were included.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Dab/tram
Patients received dabrafenib and trametinib treatment
No interventions assigned to this group
Enco/bini
Patients received encorafenib and binimetenib treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Pathologic stage III (unresectable) or IV at initial diagnosis on or after 01 January 2011
* 1L treatment with enco/bini or dab/tram on or after 01 June 2018
* Evidence of a BRAF test
* Evidence of a BRAF-positive result prior to or up to 30 days after 1L therapy initiation
Exclusion Criteria
* Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment
18 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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Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Countries
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Other Identifiers
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CTMT212AUS58
Identifier Type: -
Identifier Source: org_study_id
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