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CompletedNCT06251934Updated Feb 9, 2024

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

An observational study in BRAF-positive Metastatic Melanoma, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Novartis Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
785
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • BRAF-positive Metastatic Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 785 is above the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This was a retrospective, noninterventional cohort study.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
785 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with high tumor burden (HTB)
  • Patients with low tumor burden (LTB)
  • Patients with central nervous system (CNS) metastases
  • Patients with without CNS metastases
  • 1L IO-refractory patients
06

What researchers measure

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

    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).

    Time frame: Baseline

  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

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

    Time frame: Up to approximately 2 years

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

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

    Time frame: Up to approximately 2 years

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

    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).

    Time frame: Baseline

  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

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

    Time frame: Up to approximately 2 years

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

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

    Time frame: Up to approximately 2 years

07

Study locations

1 site
  • Novartis
    East Hanover, New Jersey 07936, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06251934
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Feb 9, 2024
Start date
Sep 28, 2022
Primary completion
Nov 1, 2022
Completion
Nov 24, 2022
Last update
Feb 9, 2024

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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