Clinical trial NCT05806268: Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
Official title: Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRAF v600 Mutated Metastatic Melanoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-04-10
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
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:
measure: Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy
timeFrame: Up to approximately 2 years
measure: Percentage of patients switching from 1L enco/bini therapy to either another targeted therapy (TT) or second-line (2L) immunotherapy (IO)
timeFrame: Up to approximately 2 years
measure: Percentage of patients switching from 1L dab/tram therapy to either another TT or IO 2L therapy
timeFrame: Up to approximately 2 years
measure: Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: