Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05806268

Enrollment

214

Registered

2023-04-10

Start date

2021-07-30

Completion date

2022-03-28

Last updated

2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRAF v600 Mutated Metastatic Melanoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini	Up to approximately 2 years

Secondary

Measure	Time frame
Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy	Up to approximately 2 years
Percentage of patients switching from 1L enco/bini therapy to either another targeted therapy (TT) or second-line (2L) immunotherapy (IO)	Up to approximately 2 years
Percentage of patients switching from 1L dab/tram therapy to either another TT or IO 2L therapy	Up to approximately 2 years
Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort	Up to approximately 2 years

Countries

United States

Outcome results