Clinical trial · Observational
Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
- 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 real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. All included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage III or IV melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 June 2018, and evidence of a BRAF-positive result prior to or up to 30 days after therapy initiation. No quota of centers was established a priori. Given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the NOBLE dataset were included.
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 v600 Mutated Metastatic Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Dab/tram
- description
- Patients received dabrafenib and trametinib treatment
- label
- Enco/bini
- description
- Patients received encorafenib and binimetenib treatment
Primary outcomes (1)
- measure
- Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini
- timeFrame
- Up to approximately 2 years
Secondary outcomes (4)
- measure
- Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy
- timeFrame
- Up to approximately 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x) * Pathologic stage III (unresectable) or IV at initial diagnosis on or after 01 January 2011 * 1L treatment with enco/bini or dab/tram on or after 01 June 2018 * Evidence of a BRAF test * Evidence of a BRAF-positive result prior to or up to 30 days after 1L therapy initiation * At least 18 years of age at the time of initiation of 1L treatment Exclusion criteria * Documented receipt of a clinical trial treatment for cancer at any time on or after September 2015 * Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment
References
Publications (0)
Data not yet available