Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-31 @ 9:59 AM
Study NCT ID:
NCT05806268
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2023-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. All included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage III or IV melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 June 2018, and evidence of a BRAF-positive result prior to or up to 30 days after therapy initiation.
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: