Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma
- Conditions
- BRAF-positive Metastatic Melanoma
- Registration Number
- NCT06251934
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 785
Not provided
- Lacking relevant unstructured documents (i.e., information such as free text from a physician note or pathology report that is captured systematically during the data abstraction process) in the Flatiron Health database
- Evidence of non-skin melanoma (ocular, subungual, mucosal, palmar, plantar)
- Documented receipt of a clinical study drug, defined as any uncancelled order, administration, or oral episode for a clinical study drug for cancer at any time prior to or during 1L treatment
- Presence of leptomeningeal disease (ICD-9 198.4 & ICD-10 C79.32 or C79.49)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category Baseline Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category Baseline Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients Baseline Mean age of 1L dab/tram-treated BRAF+ MM patients Baseline Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice Baseline Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type Baseline Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site Baseline Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients Up to approximately 2 years OS was defined as the time from the start of 1L dab/tram therapy until death from any cause.
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region Baseline Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex Baseline Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients 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.
Number and percentage of 1L dab/tram-treated BRAF+ MM patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, 2, 3, or 4 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).
Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients Baseline Time from the start of 1L dab/tram therapy until the start of 2L therapy Up to approximately 2 years Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients Baseline Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy Up to approximately 2 years
- Secondary Outcome Measures
Name Time Method Mean age of 1L IO-refractory patients with BRAF+ MM Baseline Number and percentage of 1L IO-refractory patients with BRAF+ MM per insurance type Baseline Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site Baseline Time patients remained on 1L IO therapy following disease progression Up to approximately 2 years Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex Baseline Number and proportion of patients remaining on 1L IO therapy following disease progression Up to approximately 2 years Number and percentage of 1L IO-refractory patients with BRAF+ MM with an ECOG score of 0, 1, 2, 3, or 4 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 from the start of 1L IO until the start of 2L therapy Up to approximately 2 years Time from the first disease progression until the start of 2L therapy Up to approximately 2 years OS for 1L IO-refractory patients with BRAF+ MM Up to approximately 2 years OS was defined as the time from the first disease progression until death from any cause.
Number and percentage of 1L IO-refractory patients with BRAF+ MM per type of medical practice Baseline Time from the first disease progression until next disease progression in 1L IO-refractory patients with BRAF+ MM Up to approximately 2 years Number and percentage of patients treated with 2L therapy, overall and by therapy type Up to approximately 2 years rwPFS for 1L IO-refractory patients with BRAF+ MM Up to approximately 2 years rwPFS was defined as the time from the first disease progression until next progression or death from any cause.
Number and percentage of 1L IO-refractory patients with BRAF+ MM per race category Baseline Number and percentage of 1L IO-refractory patients with BRAF+ MM per ethnicity category Baseline Number and percentage of 1L IO-refractory patients with BRAF+ MM per geographic region Baseline Alanine aminotransferase (ALT) levels in 1L IO-refractory patients with BRAF+ MM Baseline Aspartate aminotransferase (AST) levels in 1L IO-refractory patients with BRAF+ MM Baseline Lactate dehydrogenase (LDH) levels in 1L IO-refractory patients with BRAF+ MM Baseline
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States