MelanomaNCT07649252
A Study of Patient Characteristics and Treatment Patterns in Real-world Melanoma Patients Treated With Dabrafenib and Trametinib or Encorafenib and Binimetinib in Japan
An observational study of Melanoma, run by Novartis Pharmaceuticals at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 82 participants
- Where
- 1 siteJapan
- Study dates
- 1 Aug 2022to 20 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult melanoma patients prescribed dabrafenib and trametinib or encorafenib and binimetinib between 01 January 2012 and 30 June 2021 in Japan.
Who may be able to join
- 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
Show all 21Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Melanoma
- Keywords
- Melanoma, Dab+Tram, Enco+Bini, Patient profile, Treatment patterns
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-adjuvant Dab+Tram Cohort | Adult melanoma patients who were prescribed non-adjuvant Dab+Tram. | |
| Adjuvant Dab+Tram Cohort | Adult melanoma patients who were prescribed adjuvant Dab+Tram. | |
| Enco+Bini Cohort | Adult melanoma patients who were prescribed Enco+Bini. | |
| Overall Cohort | Adult melanoma patients who were prescribed Dab+Tram or Enco+Bini between 01 January 2012 and 30 June 2021. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at Date of Treatment Initiation
Age at date of treatment initiation (index date B) stratified by LoT.
Measured: Throughout the study identification period, approximately 9 years, 6 months
Number of Patients by Clinical Characteristics at the Date of Treatment Initiation
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
Measured: Throughout the study identification period, approximately 9 years, 6 months
Weight at Date of Treatment Initiation
Weight at the date of treatment initiation (index date B) stratified by LoT.
Measured: Throughout the study identification period, approximately 9 years, 6 months
Height at Date of Treatment Initiation
Height at the date of treatment initiation (index date B) stratified by LoT.
Measured: Throughout the study identification period, approximately 9 years, 6 months
BMI at Date of Treatment Initiation
BMI at the date of treatment initiation (index date B) stratified by LoT.
Measured: Throughout the study identification period, approximately 9 years, 6 months
CCI Score at Date of Treatment Initiation
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).
Measured: Throughout the study identification period, approximately 9 years, 6 months
Time From Diagnosis to First Targeted Therapy Initiation
Time from diagnosis to treatment initiation stratified by LoT.
Measured: Throughout the study identification period, approximately 9 years, 6 months
Time From Diagnosis to First Surgery
Time from diagnosis to first surgery stratified by LoT.
Measured: Throughout the study identification period, approximately 9 years, 6 months
Secondary outcomes (12)
Age at Date of Melanoma Diagnosis
Age at the date of melanoma diagnosis (index date A).
Measured: Throughout the study identification period, approximately 9 years, 6 months
Number of Patients by Gender at Date of Melanoma Diagnosis
Gender at the date of melanoma diagnosis (index date A).
Measured: Throughout the study identification period, approximately 9 years, 6 months
Number of Patients by Clinical Characteristics at the Date of Melanoma Diagnosis
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
Measured: Throughout the study identification period, approximately 9 years, 6 months
Weight at Date of Melanoma Diagnosis
Weight at the date of melanoma diagnosis (index date A).
Measured: Throughout the study identification period, approximately 9 years, 6 months
Height at Date of Melanoma Diagnosis
Height at the date of melanoma diagnosis (index date A).
Measured: Throughout the study identification period, approximately 9 years, 6 months
BMI at Date of Melanoma Diagnosis
BMI at the date of melanoma diagnosis (index date A).
Measured: Throughout the study identification period, approximately 9 years, 6 months
CCI Score at Date of Melanoma Diagnosis
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).
Measured: Throughout the study identification period, approximately 9 years, 6 months
Number of Patients by Hospital Size at Date of Melanoma Diagnosis
Number of patients by hospital size at the date of melanoma diagnosis (index date A).
Measured: Throughout the study identification period, approximately 9 years, 6 months
Proportion of Patients by Most Common Treatment Regimens (Top 5) in Each LoT
Measured: Up to approximately 10 years, 5 months
Among Patients who Initiatied Dab+Tram at the First LoT, Proportion of Patients Switching to Either Another Targeted Therapy or Immunotherapy
Measured: Up to approximately 10 years, 5 months
Among Patients who Initiatied Enco+Bini at the First LoT, Proportion of Patients Switching to Either Another Targeted Therapy or Immunotherapy
Measured: Up to approximately 10 years, 5 months
Proportion of Patients who Discontinued Treatment
Measured: Up to approximately 10 years, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Aug 2022
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649252
- Sponsor's protocol ID
- CDRB436BJP01
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07649252
- Acronym / sponsor ID
- CDRB436BJP01
- Conditions
- Melanoma
- Keywords
- Melanoma, Dab+Tram, Enco+Bini, Patient profile, Treatment patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-adjuvant Dab+Tram Cohort | – | –Adult melanoma patients who were prescribed non-adjuvant Dab+Tram. |
| Adjuvant Dab+Tram Cohort | – | –Adult melanoma patients who were prescribed adjuvant Dab+Tram. |
| Enco+Bini Cohort | – | –Adult melanoma patients who were prescribed Enco+Bini. |
| Overall Cohort | – | –Adult melanoma patients who were prescribed Dab+Tram or Enco+Bini between 01 January 2012 and 30 June 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult melanoma patients prescribed dabrafenib and trametinib or encorafenib and binimetinib between 01 January 2012 and 30 June 2021 in Japan.
Key inclusion criteria (21 listed)
- 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).
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
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.
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.
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).
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.
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.
12 secondary outcomes
Age at Date of Melanoma Diagnosis
Time frame: Throughout the study identification period, approximately 9 years, 6 months
Number of Patients by Gender at Date of Melanoma Diagnosis
Time frame: Throughout the study identification period, approximately 9 years, 6 months
Number of Patients by Clinical Characteristics at the Date of Melanoma Diagnosis
Time frame: Throughout the study identification period, approximately 9 years, 6 months
Weight at Date of Melanoma Diagnosis
Time frame: Throughout the study identification period, approximately 9 years, 6 months
Height at Date of Melanoma Diagnosis
Time frame: Throughout the study identification period, approximately 9 years, 6 months
BMI at Date of Melanoma Diagnosis
Time frame: Throughout the study identification period, approximately 9 years, 6 months
CCI Score at Date of Melanoma Diagnosis
Time frame: Throughout the study identification period, approximately 9 years, 6 months
Number of Patients by Hospital Size at Date of Melanoma Diagnosis
Time frame: Throughout the study identification period, approximately 9 years, 6 months
Proportion of Patients by Most Common Treatment Regimens (Top 5) in Each LoT
Time frame: Up to approximately 10 years, 5 months
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
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
Proportion of Patients who Discontinued Treatment
Time frame: Up to approximately 10 years, 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Novartis Pharmaceuticals at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at Date of Treatment Initiation (time frame: Throughout the study identification period, approximately 9 years, 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.