BRAF Positive Metastatic MelanomaNCT05984615
Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients
An observational study of BRAF Positive Metastatic Melanoma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective real-world evidence cohort study. 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
- 1,961 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 24 Aug 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 (The International Classification of Diseases, 9th Revision [ICD-9] 172.x \& 10th revision [ICD-10] C43 or D03x).
- Pathologic stage IV at initial diagnosis on or after 01 January 2011.
- First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014.
- Evidence of a BRAF test.
- Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation.
- At least 18 years of age at the time of initiation of 1L treatment.
Who cannot join
- Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014.
- Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective real-world evidence cohort study.
- 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 |
|---|---|---|
| Immunotherapy (IO) Cohort | Not described | |
| Targeted Therapy (TT) Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean age
Measured: Baseline
Number of male patients
Measured: Baseline
Race
Measured: Baseline
Mean Charlson comorbidity index (CCI) score
Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.
Measured: Baseline
Eastern Cooperative Oncology Group performance status (ECOG PS)
The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled.
Measured: Baseline
Number of patients with study-related biomarkers
Study-related biomarkers included BRAF and PD1/PDL1 test dates and results.
Measured: Baseline
Number of metastatic sites
Measured: Baseline
Secondary outcomes (2)
Progression-free survival (PFS)
PFS was defined as the time from the initiation of a line of therapy until the date of progression or death.
Measured: 6 months and 1, 1.5, and 2 years
Overall survival (OS)
OS was defined as the time from the initiation of a line of therapy until death from any cause.
Measured: 6 months and 1, 1.5, and 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 Aug 2023
- Study start8 Jun 2022
- Primary completion24 Aug 2022
- Study completion24 Aug 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
- 1,961 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
- NCT05984615
- Sponsor's protocol ID
- CTMT212AUS63
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients
- ClinicalTrials.gov ID
- NCT05984615
- Acronym / sponsor ID
- CTMT212AUS63
- Conditions
- BRAF Positive Metastatic Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,961 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 9 Aug 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy (IO) Cohort | – | – |
| Targeted Therapy (TT) Cohort | – | – |
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 (6 listed)
- Diagnosis of melanoma (The International Classification of Diseases, 9th Revision [ICD-9] 172.x \& 10th revision [ICD-10] C43 or D03x).
- Pathologic stage IV at initial diagnosis on or after 01 January 2011.
- First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014.
- Evidence of a BRAF test.
- Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation.
Key exclusion criteria (2 listed)
- Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014.
- Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.
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
Time frame: Baseline
Number of male patients
Time frame: Baseline
Race
Time frame: Baseline
Mean Charlson comorbidity index (CCI) score
Time frame: Baseline
Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.
Eastern Cooperative Oncology Group performance status (ECOG PS)
Time frame: Baseline
The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled.
Number of patients with study-related biomarkers
Time frame: Baseline
Study-related biomarkers included BRAF and PD1/PDL1 test dates and results.
Number of metastatic sites
Time frame: Baseline
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 6 months and 1, 1.5, and 2 years
Overall survival (OS)
Time frame: 6 months and 1, 1.5, and 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 Aug 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 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 6 inclusion and 2 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 Aug 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?
Mean age (time frame: Baseline). The study lists 7 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 Aug 2023.