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

March 28, 2023 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dab/tram
Patients received dabrafenib and trametinib treatment
Enco/bini
Patients received encorafenib and binimetenib treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy
Time Frame: Up to approximately 2 years
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)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of patients switching from 1L dab/tram therapy to either another TT or IO 2L therapy
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2021

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

March 28, 2022

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMT212AUS58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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