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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05806268
Collaborator
(none)
214
Enrollment
1
Location
7.9
Actual Duration (Months)
27
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    214 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jul 30, 2021
    Actual Primary Completion Date :
    Mar 28, 2022
    Actual Study Completion Date :
    Mar 28, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Dab/tram

    Patients received dabrafenib and trametinib treatment
    Enco/bini

    Patients received encorafenib and binimetenib treatment

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy [Up to approximately 2 years]

    2. 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]

    3. Percentage of patients switching from 1L dab/tram therapy to either another TT or IO 2L therapy [Up to approximately 2 years]

    4. Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort [Up to approximately 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Pharmaceuticals East Hanover New Jersey United States 07936

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05806268
    Other Study ID Numbers:
    • CTMT212AUS58
    First Posted:
    Apr 10, 2023
    Last Update Posted:
    Apr 10, 2023
    Last Verified:
    Mar 1, 2023
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Apr 10, 2023