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OpenTrials
Completed

NCT Number: NCT06251934

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Mean age of 1L dab/tram-treated BRAF+ MM patients

    Time frame: Baseline

  2. Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex

    Time frame: Baseline

  3. Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category

    Time frame: Baseline

  4. Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category

    Time frame: Baseline

  5. Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region

    Time frame: Baseline

  6. Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice

    Time frame: Baseline

  7. Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type

    Time frame: Baseline

  8. Number and percentage of 1L dab/tram-treated BRAF+ MM patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, 2, 3, or 4

    Time frame: Baseline

    ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).

  9. Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site

    Time frame: Baseline

  10. Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients

    Time frame: Baseline

  11. Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients

    Time frame: Baseline

  12. Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients

    Time frame: Baseline

  13. Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy

    Time frame: Up to approximately 2 years

  14. Time from the start of 1L dab/tram therapy until the start of 2L therapy

    Time frame: Up to approximately 2 years

  15. Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients

    Time frame: Up to approximately 2 years

    rwPFS was defined as the time from the start of 1L dab/tram therapy until first progression or death from any cause.

  16. Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients

    Time frame: Up to approximately 2 years

    OS was defined as the time from the start of 1L dab/tram therapy until death from any cause.

Secondary outcomes

  1. Mean age of 1L IO-refractory patients with BRAF+ MM

    Time frame: Baseline

  2. Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex

    Time frame: Baseline

  3. Number and percentage of 1L IO-refractory patients with BRAF+ MM per race category

    Time frame: Baseline

  4. Number and percentage of 1L IO-refractory patients with BRAF+ MM per ethnicity category

    Time frame: Baseline

  5. Number and percentage of 1L IO-refractory patients with BRAF+ MM per geographic region

    Time frame: Baseline

  6. Number and percentage of 1L IO-refractory patients with BRAF+ MM per type of medical practice

    Time frame: Baseline

  7. Number and percentage of 1L IO-refractory patients with BRAF+ MM per insurance type

    Time frame: Baseline

  8. Number and percentage of 1L IO-refractory patients with BRAF+ MM with an ECOG score of 0, 1, 2, 3, or 4

    Time frame: Baseline

    ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).

  9. Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site

    Time frame: Baseline

  10. Alanine aminotransferase (ALT) levels in 1L IO-refractory patients with BRAF+ MM

    Time frame: Baseline

  11. Aspartate aminotransferase (AST) levels in 1L IO-refractory patients with BRAF+ MM

    Time frame: Baseline

  12. Lactate dehydrogenase (LDH) levels in 1L IO-refractory patients with BRAF+ MM

    Time frame: Baseline

  13. Time from the first disease progression until next disease progression in 1L IO-refractory patients with BRAF+ MM

    Time frame: Up to approximately 2 years

  14. Number and proportion of patients remaining on 1L IO therapy following disease progression

    Time frame: Up to approximately 2 years

  15. Time patients remained on 1L IO therapy following disease progression

    Time frame: Up to approximately 2 years

  16. Number and percentage of patients treated with 2L therapy, overall and by therapy type

    Time frame: Up to approximately 2 years

  17. Time from the start of 1L IO until the start of 2L therapy

    Time frame: Up to approximately 2 years

  18. Time from the first disease progression until the start of 2L therapy

    Time frame: Up to approximately 2 years

  19. rwPFS for 1L IO-refractory patients with BRAF+ MM

    Time frame: Up to approximately 2 years

    rwPFS was defined as the time from the first disease progression until next progression or death from any cause.

  20. OS for 1L IO-refractory patients with BRAF+ MM

    Time frame: Up to approximately 2 years

    OS was defined as the time from the first disease progression until death from any cause.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.