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: BRAF v600 Mutated Metastatic Melanoma

• Registration Number: NCT05806268
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Primary Completion: 2022-03-28
• Study Completion: 2022-03-28
• Status Verified: 2023-03
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort	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 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 receiving enco/bini or dab/tram in the 1L of therapy	Up to approximately 2 years

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States