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Completed

NCT Number: NCT07649252

A Study of Patient Characteristics and Treatment Patterns in Real-world Melanoma Patients Treated With Dabrafenib and Trametinib or Encorafenib and Binimetinib in Japan

The aim of this study was to describe the patient profile and treatment patterns of adult melanoma patients that were treated with either dabrafenib and trametinib (Dab+Tram) or encorafenib and binimetinib (Enco+Bini) between 01 January 2012 and 30 November 2021 in Japan.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharma K.K.

Tokyo, 105-6333, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients who met all of the following criteria were included:

  • Had a confirmed diagnosis of melanoma recorded during the identification period, and
  • Had at least 6 months of enrollment before the index date A, where index date A was defined as the first date of a confirmed diagnosis of melanoma recorded during the identification period, and
  • Were at least 18 years old at the time of initiation of the first line of treatment (LoT).

The Adjuvant Dab+Tram Cohort included all patients who met all of the following criteria:

  • Satisfied all of the general inclusion criteria, and
  • Had a dabrafenib prescription claim and a trametinib prescription claim recorded after or at the index date A, and
  • Had at least 6 months of follow-up after the index date B, where index B was defined as the first date of a prescription recorded at or after index date A, and
  • Had the first dabrafenib or trametinib prescription claim recorded within 12 weeks of an excision surgery, and
  • Did not have a confirmed metastasis diagnosis recorded within 1 month before, at, or within 12 weeks after the index date A.

The Non-adjuvant Dab+Tram Cohort included all patients that met all of the following criteria:

  • Satisfied all of the general inclusion criteria, and
  • Had a dabrafenib prescription claim and a trametinib prescription claim recorded after or at the index date A, and
  • Had at least 6 months of follow-up after the index date B, and
  • Not included in the Adjuvant Dab+Tram Cohort.

The Cohort Enco+Bini included all patients that met all of the following criteria:

  • Satisfied all of the general inclusion criteria, and
  • Had an encorafenib prescription claim and a binimetinib prescription claim recorded after or at the index date A, and
  • Had at least 6 months of follow-up after the index date B.

The Overall Cohort included all patients that met all of the following criteria:

  • Included in either the Adjuvant Dab+Tram Cohort, the Non-adjuvant Dab+Tram Cohort, or the Enco+Bini Cohort. A patient could be considered in multiple cohorts and was considered once only in analysis of the Overall Cohort.

Exclusion criteria

  • Had a prescription claim with a melanoma treatment recorded within 6 months before the index date A, or
  • Had a confirmed diagnosis of a non-small cell lung cancer recorded any time before the index date A for the Adjuvant Dab+Tram Cohort and the Non-adjuvant Dab+Tram Cohort, or
  • Had a confirmed diagnosis of a colorectal cancer recorded any time before the index date A for the Enco+Bini Cohort.

Treatment and study plan

Primary outcomes

  1. Age at Date of Treatment Initiation

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Age at date of treatment initiation (index date B) stratified by LoT.

  2. Number of Patients by Clinical Characteristics at the Date of Treatment Initiation

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Clinical characteristics at the date of treatment initiation (index date B) stratified by LoT. Clinical Characteristics included:

    • Index calendar year
    • Age group
    • Body mass index (BMI) category
    • Charlson comorbidity index (CCI) category
    • Tumor, Node, Metastases (TNM) stage
    • Type of surgery before treatment initiation

  3. Weight at Date of Treatment Initiation

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Weight at the date of treatment initiation (index date B) stratified by LoT.

  4. Height at Date of Treatment Initiation

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Height at the date of treatment initiation (index date B) stratified by LoT.

  5. BMI at Date of Treatment Initiation

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    BMI at the date of treatment initiation (index date B) stratified by LoT.

  6. CCI Score at Date of Treatment Initiation

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    CCI score at the date of treatment initiation (index date B) stratified by LoT. CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be classified as low (0-1) and high (≥2).

  7. Time From Diagnosis to First Targeted Therapy Initiation

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Time from diagnosis to treatment initiation stratified by LoT.

  8. Time From Diagnosis to First Surgery

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Time from diagnosis to first surgery stratified by LoT.

Secondary outcomes

  1. Age at Date of Melanoma Diagnosis

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Age at the date of melanoma diagnosis (index date A).

  2. Number of Patients by Gender at Date of Melanoma Diagnosis

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Gender at the date of melanoma diagnosis (index date A).

  3. Number of Patients by Clinical Characteristics at the Date of Melanoma Diagnosis

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Clinical characteristics at the date of melanoma diagnosis (index date A). Clinical Characteristics included:

    • Index calendar year
    • Age group
    • BMI category
    • CCI category
    • TNM stage

  4. Weight at Date of Melanoma Diagnosis

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Weight at the date of melanoma diagnosis (index date A).

  5. Height at Date of Melanoma Diagnosis

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Height at the date of melanoma diagnosis (index date A).

  6. BMI at Date of Melanoma Diagnosis

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    BMI at the date of melanoma diagnosis (index date A).

  7. CCI Score at Date of Melanoma Diagnosis

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    CCI score at the date of melanoma diagnosis (index date A). CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be classified as low (0-1) and high (≥2).

  8. Number of Patients by Hospital Size at Date of Melanoma Diagnosis

    Time frame: Throughout the study identification period, approximately 9 years, 6 months

    Number of patients by hospital size at the date of melanoma diagnosis (index date A).

  9. Proportion of Patients by Most Common Treatment Regimens (Top 5) in Each LoT

    Time frame: Up to approximately 10 years, 5 months

  10. Among Patients who Initiatied Dab+Tram at the First LoT, Proportion of Patients Switching to Either Another Targeted Therapy or Immunotherapy

    Time frame: Up to approximately 10 years, 5 months

  11. Among Patients who Initiatied Enco+Bini at the First LoT, Proportion of Patients Switching to Either Another Targeted Therapy or Immunotherapy

    Time frame: Up to approximately 10 years, 5 months

  12. Proportion of Patients who Discontinued Treatment

    Time frame: Up to approximately 10 years, 5 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Non-interventional and Retrospective Study Describing the Patient Profile and Treatment Patterns in Real-world Melanoma Patients Prescribed With Dab+Tram or Enco+Bini in Japan

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2026
Registry last updated
Jun 17, 2026

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.

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