BRAF-positive Metastatic MelanomaNCT06251934
Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma
An observational study of BRAF-positive Metastatic Melanoma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BRAF-positive Metastatic Melanoma
- How many people
- 785 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 24 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: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Diagnosis of melanoma (ICD-9 172x \& ICD-10 C43 or D03x)
- ≥2 documented clinical encounters on different days in the Flatiron network on or after 01 January 2011
- Pathologic unresectable stage III or IV at initial diagnosis after 01 January 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 January 2011
- Diagnosis of MM after 01 January 2011
- Evidence of a BRAF-positive result at any point in time
- Treatment with one of the following 1L therapies on or after 01 January 2014:
Show all 10Show fewer
- IO (nivolumab, pembrolizumab, or ipilimumab + nivolumab)
- TT (dab/tram)
- At least 18 years of age at the time of initiation of 1L therapy
- At least 6-months of continuous follow-up from the time of initiation of 1L therapy
Who cannot join
- Lacking relevant unstructured documents (i.e., information such as free text from a physician note or pathology report that is captured systematically during the data abstraction process) in the Flatiron Health database
- Evidence of non-skin melanoma (ocular, subungual, mucosal, palmar, plantar)
- Documented receipt of a clinical study drug, defined as any uncancelled order, administration, or oral episode for a clinical study drug for cancer at any time prior to or during 1L treatment
- Presence of leptomeningeal disease (ICD-9 198.4 \& ICD-10 C79.32 or C79.49)
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. All included patients were aged ≥18 years and required to have a diagnosis of melanoma (International Classification of Diseases (ICD)-9 172.x \& ICD-10 C43 or D03x), a pathologic unresectable stage III or IV diagnosis, subsequent first-line (1L) treatment with either immunotherapy (IO) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (TT) dafratenib + trametinib (dab/tram) on or after 01 January 2014, and evidence of a BRAF-positive result at any point in time.
- Conditions
- BRAF-positive 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 |
|---|---|---|
| Patients with high tumor burden (HTB) | Not described | |
| Patients with low tumor burden (LTB) | Not described | |
| Patients with central nervous system (CNS) metastases | Not described | |
| Patients with without CNS metastases | Not described | |
| 1L IO-refractory patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean age of 1L dab/tram-treated BRAF+ MM patients
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, 2, 3, or 4
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site
Measured: Baseline
Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients
Measured: Baseline
Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients
Measured: Baseline
Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients
Measured: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy
Measured: Up to approximately 2 years
Time from the start of 1L dab/tram therapy until the start of 2L therapy
Measured: Up to approximately 2 years
Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients
rwPFS was defined as the time from the start of 1L dab/tram therapy until first progression or death from any cause.
Measured: Up to approximately 2 years
Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients
OS was defined as the time from the start of 1L dab/tram therapy until death from any cause.
Measured: Up to approximately 2 years
Secondary outcomes (20)
Mean age of 1L IO-refractory patients with BRAF+ MM
Measured: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex
Measured: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per race category
Measured: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per ethnicity category
Measured: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per geographic region
Measured: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per type of medical practice
Measured: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per insurance type
Measured: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM with an ECOG score of 0, 1, 2, 3, or 4
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Measured: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site
Measured: Baseline
Alanine aminotransferase (ALT) levels in 1L IO-refractory patients with BRAF+ MM
Measured: Baseline
Aspartate aminotransferase (AST) levels in 1L IO-refractory patients with BRAF+ MM
Measured: Baseline
Lactate dehydrogenase (LDH) levels in 1L IO-refractory patients with BRAF+ MM
Measured: Baseline
Time from the first disease progression until next disease progression in 1L IO-refractory patients with BRAF+ MM
Measured: Up to approximately 2 years
Number and proportion of patients remaining on 1L IO therapy following disease progression
Measured: Up to approximately 2 years
Time patients remained on 1L IO therapy following disease progression
Measured: Up to approximately 2 years
Number and percentage of patients treated with 2L therapy, overall and by therapy type
Measured: Up to approximately 2 years
Time from the start of 1L IO until the start of 2L therapy
Measured: Up to approximately 2 years
Time from the first disease progression until the start of 2L therapy
Measured: Up to approximately 2 years
rwPFS for 1L IO-refractory patients with BRAF+ MM
rwPFS was defined as the time from the first disease progression until next progression or death from any cause.
Measured: Up to approximately 2 years
OS for 1L IO-refractory patients with BRAF+ MM
OS was defined as the time from the first disease progression until death from any cause.
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 posted9 Feb 2024
- Study start28 Sep 2022
- Primary completion1 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRAF-positive 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
- 785 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
- NCT06251934
- Sponsor's protocol ID
- CTMT212AUS66
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT06251934
- Acronym / sponsor ID
- CTMT212AUS66
- Conditions
- BRAF-positive Metastatic Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 785 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 9 Feb 2024 (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, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. All included patients were aged ≥18 years and required to have a diagnosis of melanoma (International Classification of Diseases (ICD)-9 172.x \& ICD-10 C43 or D03x), a pathologic unresectable stage III or IV diagnosis, subsequent first-line (1L) treatment with either immunotherapy (IO) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (TT) dafratenib + trametinib (dab/tram) on or after 01 January 2014, and evidence of a BRAF-positive result at any point in time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with high tumor burden (HTB) | – | – |
| Patients with low tumor burden (LTB) | – | – |
| Patients with central nervous system (CNS) metastases | – | – |
| Patients with without CNS metastases | – | – |
| 1L IO-refractory patients | – | – |
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 (10 listed)
- Diagnosis of melanoma (ICD-9 172x \& ICD-10 C43 or D03x)
- ≥2 documented clinical encounters on different days in the Flatiron network on or after 01 January 2011
- Pathologic unresectable stage III or IV at initial diagnosis after 01 January 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 January 2011
- Diagnosis of MM after 01 January 2011
- Evidence of a BRAF-positive result at any point in time
Key exclusion criteria (4 listed)
- Lacking relevant unstructured documents (i.e., information such as free text from a physician note or pathology report that is captured systematically during the data abstraction process) in the Flatiron Health database
- Evidence of non-skin melanoma (ocular, subungual, mucosal, palmar, plantar)
- Documented receipt of a clinical study drug, defined as any uncancelled order, administration, or oral episode for a clinical study drug for cancer at any time prior to or during 1L treatment
- Presence of leptomeningeal disease (ICD-9 198.4 \& ICD-10 C79.32 or C79.49)
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
Mean age of 1L dab/tram-treated BRAF+ MM patients
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, 2, 3, or 4
Time frame: Baseline
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site
Time frame: Baseline
Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients
Time frame: Baseline
Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients
Time frame: Baseline
Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy
Time frame: Up to approximately 2 years
Time from the start of 1L dab/tram therapy until the start of 2L therapy
Time frame: Up to approximately 2 years
Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients
Time frame: Up to approximately 2 years
rwPFS was defined as the time from the start of 1L dab/tram therapy until first progression or death from any cause.
Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients
Time frame: Up to approximately 2 years
OS was defined as the time from the start of 1L dab/tram therapy until death from any cause.
20 secondary outcomes
Mean age of 1L IO-refractory patients with BRAF+ MM
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per race category
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per ethnicity category
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per geographic region
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per type of medical practice
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per insurance type
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM with an ECOG score of 0, 1, 2, 3, or 4
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site
Time frame: Baseline
Alanine aminotransferase (ALT) levels in 1L IO-refractory patients with BRAF+ MM
Time frame: Baseline
Aspartate aminotransferase (AST) levels in 1L IO-refractory patients with BRAF+ MM
Time frame: Baseline
Lactate dehydrogenase (LDH) levels in 1L IO-refractory patients with BRAF+ MM
Time frame: Baseline
Time from the first disease progression until next disease progression in 1L IO-refractory patients with BRAF+ MM
Time frame: Up to approximately 2 years
Number and proportion of patients remaining on 1L IO therapy following disease progression
Time frame: Up to approximately 2 years
Time patients remained on 1L IO therapy following disease progression
Time frame: Up to approximately 2 years
Number and percentage of patients treated with 2L therapy, overall and by therapy type
Time frame: Up to approximately 2 years
Time from the start of 1L IO until the start of 2L therapy
Time frame: Up to approximately 2 years
Time from the first disease progression until the start of 2L therapy
Time frame: Up to approximately 2 years
rwPFS for 1L IO-refractory patients with BRAF+ MM
Time frame: Up to approximately 2 years
OS for 1L IO-refractory patients with BRAF+ MM
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 9 Feb 2024.
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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-positive 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 10 inclusion and 4 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 9 Feb 2024. 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?
Mean age of 1L dab/tram-treated BRAF+ MM patients (time frame: Baseline). The study lists 16 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 9 Feb 2024.