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Melanoma treatment patterns in japan: what Real-World data reveals

NCT ID NCT07649252

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study examines the patient profiles and treatment patterns of adults with melanoma in Japan who were prescribed either dabrafenib with trametinib or encorafenib with binimetinib. Researchers are looking at data from 2012 to 2021 to understand patient characteristics and how these targeted therapies are used in everyday practice. The goal is to gather real-world evidence that may inform future treatment approaches.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand how melanoma patients in Japan respond to targeted therapies, potentially improving treatment decisions.
What could go wrong
This is an observational study that does not test a new treatment, so it cannot prove what works best. Results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

82 people

The number who actually took part.

Started

Aug 2022

Finished

Nov 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult melanoma patients prescribed dabrafenib and trametinib or encorafenib and binimetinib between 01 January 2012 and 30 June 2021 in Japan.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Novartis Pharma K.K.

    Tokyo, 105-6333, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.