Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
Completed
Conditions studied: BRAF v600 Mutated Metastatic Melanoma
In brief
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.
Key facts
- Study ID
- NCT05806268
- Run by
- Novartis Pharmaceuticals
- People needed
- 214
- Starts
- 2021-07-30
- Expected to finish
- 2022-03-28
- Last updated by the study team
- 2023-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Novartis Pharmaceuticals — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.