Novartis
East Hanover, New Jersey, 07936, United States
NCT Number: NCT06251934
This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. All included patients were aged ≥18 years and required to have a diagnosis of melanoma (International Classification of Diseases (ICD)-9 172.x & ICD-10 C43 or D03x), a pathologic unresectable stage III or IV diagnosis, subsequent first-line (1L) treatment with either immunotherapy (IO) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (TT) dafratenib + trametinib (dab/tram) on or after 01 January 2014, and evidence of a BRAF-positive result at any point in time.
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Notify Me18 year and older
All sexes
Observational
East Hanover, New Jersey, 07936, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Up to approximately 2 years
Time frame: Up to approximately 2 years
Time frame: Up to approximately 2 years
rwPFS was defined as the time from the start of 1L dab/tram therapy until first progression or death from any cause.
Time frame: Up to approximately 2 years
OS was defined as the time from the start of 1L dab/tram therapy until death from any cause.
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Up to approximately 2 years
Time frame: Up to approximately 2 years
Time frame: Up to approximately 2 years
Time frame: Up to approximately 2 years
Time frame: Up to approximately 2 years
Time frame: Up to approximately 2 years
Time frame: Up to approximately 2 years
rwPFS was defined as the time from the first disease progression until next progression or death from any cause.
Time frame: Up to approximately 2 years
OS was defined as the time from the first disease progression until death from any cause.
Novartis Pharmaceuticals
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.