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 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 age Baseline 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.
Number of metastatic sites Baseline Number of male patients Baseline Race Baseline
- 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
Novartis🇺🇸East Hanover, New Jersey, United States