Melanoma Clinical Trial

Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma

Summary

This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. All included patients were aged ≥18 years and required to have a diagnosis of melanoma (International Classification of Diseases (ICD)-9 172.x & ICD-10 C43 or D03x), a pathologic unresectable stage III or IV diagnosis, subsequent first-line (1L) treatment with either immunotherapy (IO) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (TT) dafratenib + trametinib (dab/tram) on or after 01 January 2014, and evidence of a BRAF-positive result at any point in time.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Diagnosis of melanoma (ICD-9 172x & ICD-10 C43 or D03x)
≥2 documented clinical encounters on different days in the Flatiron network on or after 01 January 2011
Pathologic unresectable stage III or IV at initial diagnosis after 01 January 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 January 2011
Diagnosis of MM after 01 January 2011
Evidence of a BRAF-positive result at any point in time

Treatment with one of the following 1L therapies on or after 01 January 2014:

IO (nivolumab, pembrolizumab, or ipilimumab + nivolumab)
TT (dab/tram)
At least 18 years of age at the time of initiation of 1L therapy
At least 6-months of continuous follow-up from the time of initiation of 1L therapy

Exclusion Criteria:

Lacking relevant unstructured documents (i.e., information such as free text from a physician note or pathology report that is captured systematically during the data abstraction process) in the Flatiron Health database
Evidence of non-skin melanoma (ocular, subungual, mucosal, palmar, plantar)
Documented receipt of a clinical study drug, defined as any uncancelled order, administration, or oral episode for a clinical study drug for cancer at any time prior to or during 1L treatment
Presence of leptomeningeal disease (ICD-9 198.4 & ICD-10 C79.32 or C79.49)

Study is for people with:

Melanoma

Estimated Enrollment:

785

Study ID:

NCT06251934

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There is 1 Location for this study

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Novartis
East Hanover New Jersey, 07936, United States

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Study is for people with:

Melanoma

Estimated Enrollment:

785

Study ID:

NCT06251934

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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