Clinical trial · Observational
Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF-positive Metastatic Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (5)
- label
- Patients with high tumor burden (HTB)
- label
- Patients with low tumor burden (LTB)
- label
- Patients with central nervous system (CNS) metastases
- label
- Patients with without CNS metastases
- label
- 1L IO-refractory patients
Primary outcomes (16)
- measure
- Mean age of 1L dab/tram-treated BRAF+ MM patients
- timeFrame
- Baseline
- measure
- Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Diagnosis of melanoma (ICD-9 172x \& ICD-10 C43 or D03x) * ≥2 documented clinical encounters on different days in the Flatiron network on or after 01 January 2011 * Pathologic unresectable stage III or IV at initial diagnosis after 01 January 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 January 2011 * Diagnosis of MM after 01 January 2011 * Evidence of a BRAF-positive result at any point in time * Treatment with one of the following 1L therapies on or after 01 January 2014: * IO (nivolumab, pembrolizumab, or ipilimumab + nivolumab) * TT (dab/tram) * At least 18 years of age at the time of initiation of 1L therapy * At least 6-months of continuous follow-up from the time of initiation of 1L therapy Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available