Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients
Completed
- Conditions
- BRAF Positive Metastatic Melanoma
- Registration Number
- NCT05984615
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This was a retrospective real-world evidence cohort study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1961
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of metastatic sites Baseline Mean age Baseline Number of male patients Baseline Race Baseline Eastern Cooperative Oncology Group performance status (ECOG PS) Baseline The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled.
Mean Charlson comorbidity index (CCI) score Baseline Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.
Number of patients with study-related biomarkers Baseline Study-related biomarkers included BRAF and PD1/PDL1 test dates and results.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 6 months and 1, 1.5, and 2 years PFS was defined as the time from the initiation of a line of therapy until the date of progression or death.
Overall survival (OS) 6 months and 1, 1.5, and 2 years OS was defined as the time from the initiation of a line of therapy until death from any cause.
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States