Melanoma Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Estimated Enrollment:

214

Study ID:

NCT05806268

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There is 1 Location for this study

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Novartis Pharmaceuticals
East Hanover New Jersey, 07936, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

214

Study ID:

NCT05806268

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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