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

NCT07649252

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Melanoma

Countries: 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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (1)
  • Tokyo, Japan