BRAF v600 Mutated Metastatic MelanomaNCT05806268
Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
An observational study of BRAF v600 Mutated Metastatic Melanoma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BRAF v600 Mutated Metastatic Melanoma
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2021to 28 Mar 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: This was a retrospective, noninterventional cohort study
Who may be able to join
- Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x)
- Pathologic stage III (unresectable) or IV at initial diagnosis on or after 01 January 2011
- 1L treatment with enco/bini or dab/tram on or after 01 June 2018
- Evidence of a BRAF test
- Evidence of a BRAF-positive result prior to or up to 30 days after 1L therapy initiation
- At least 18 years of age at the time of initiation of 1L treatment Exclusion criteria
- Documented receipt of a clinical trial treatment for cancer at any time on or after September 2015
- Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. All included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage III or IV melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 June 2018, and evidence of a BRAF-positive result prior to or up to 30 days after therapy initiation.
No quota of centers was established a priori. Given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the NOBLE dataset were included.
- Conditions
- BRAF v600 Mutated Metastatic 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 |
|---|---|---|
| Dab/tram | Patients received dabrafenib and trametinib treatment | |
| Enco/bini | Patients received encorafenib and binimetenib treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini
Measured: Up to approximately 2 years
Secondary outcomes (4)
Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy
Measured: Up to approximately 2 years
Percentage of patients switching from 1L enco/bini therapy to either another targeted therapy (TT) or second-line (2L) immunotherapy (IO)
Measured: Up to approximately 2 years
Percentage of patients switching from 1L dab/tram therapy to either another TT or IO 2L therapy
Measured: Up to approximately 2 years
Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start30 Jul 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRAF v600 Mutated Metastatic 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
- 214 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
- NCT05806268
- Sponsor's protocol ID
- CTMT212AUS58
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
- ClinicalTrials.gov ID
- NCT05806268
- Acronym / sponsor ID
- CTMT212AUS58
- Conditions
- BRAF v600 Mutated Metastatic Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 10 Apr 2023 (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.
This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. All included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage III or IV melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 June 2018, and evidence of a BRAF-positive result prior to or up to 30 days after therapy initiation.
No quota of centers was established a priori. Given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the NOBLE dataset were included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dab/tram | – | –Patients received dabrafenib and trametinib treatment |
| Enco/bini | – | –Patients received encorafenib and binimetenib treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (8 listed)
- Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x)
- Pathologic stage III (unresectable) or IV at initial diagnosis on or after 01 January 2011
- 1L treatment with enco/bini or dab/tram on or after 01 June 2018
- Evidence of a BRAF test
- Evidence of a BRAF-positive result prior to or up to 30 days after 1L therapy initiation
Key exclusion criteria (0 listed)
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
Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini
Time frame: Up to approximately 2 years
4 secondary outcomes
Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy
Time frame: Up to approximately 2 years
Percentage of patients switching from 1L enco/bini therapy to either another targeted therapy (TT) or second-line (2L) immunotherapy (IO)
Time frame: Up to approximately 2 years
Percentage of patients switching from 1L dab/tram therapy to either another TT or IO 2L therapy
Time frame: Up to approximately 2 years
Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort
Time frame: Up to approximately 2 years
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 10 Apr 2023.
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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 BRAF v600 Mutated Metastatic Melanoma, run by Novartis Pharmaceuticals at 1 site in United States.
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 8 inclusion and 0 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 10 Apr 2023. 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 United States. 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?
Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini (time frame: Up to approximately 2 years). 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 10 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.