Clinical trial · Observational
A Study of Patient Characteristics and Treatment Patterns in Real-world Melanoma Patients Treated With Dabrafenib and Trametinib or Encorafenib and Binimetinib in Japan
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
NCT07649252CI-TRIAL-00115143completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Non-adjuvant Dab+Tram Cohort
- description
- Adult melanoma patients who were prescribed non-adjuvant Dab+Tram.
- label
- Adjuvant Dab+Tram Cohort
- description
- Adult melanoma patients who were prescribed adjuvant Dab+Tram.
- label
- Enco+Bini Cohort
- description
- Adult melanoma patients who were prescribed Enco+Bini.
- label
- Overall Cohort
- description
- Adult melanoma patients who were prescribed Dab+Tram or Enco+Bini between 01 January 2012 and 30 June 2021.
Primary outcomes (8)
- measure
- Age at Date of Treatment Initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.