Metastatic MelanomaNCT05611229
Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden
An observational study of Metastatic Melanoma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was an observational study utilizing electronic health record (EHR)-derived data collected retrospectively during routine care of real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Nivolumab, Pembrolizumab and Dabrafenib+Trametinib
- Type of treatment
- Injection or infusion
- How many people
- 1,975 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 3 Dec 2021
- 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: Real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset
Who may be able to join
- Population 1(patients treated in the adjuvant setting)
- Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x)
- Pathologic stage III on or after 2011
- Evidence of resection
- Adjuvant treatment with IO (nivo, pembro) or TT (dab+tram) on or after 1/1/2014 and prior to 8/31/2020
- At least 6 months of follow-up time (until death, end of data cut-off, loss-of-follow-up, or progressed to stage IV diagnosis) from the initiation of therapy
Show all 18Show fewer
- Evidence of a BRAF+ result ≤30 days after therapy initiation in the adjuvant setting
- At least 18 years of age at the time of initiation of treatment
- No documented receipt of a clinical trial treatment for cancer at any time on or after January 1, 2014
- Population 2 (patients with LTB treated in the metastatic setting)
- Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x)
- Pathologic stage IV at initial diagnosis on or after 1/1/2011, or earlier stage disease accompanied by development of a first locoregional recurrence on or after 1/1/2011
- 1L treatment with IO (ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vemu+cobi, enco+bini) on or after 1/1/2014 and prior to 5/31/2020
- At least 6 months of follow-up time (until death, loss of follow-up, or end of data cut-off) from the initiation of therapy
- Evidence of a BRAF+ result ≤30 days after 1L therapy initiation
- LTB, defined as having <3 involved organ sites and normal LDH test (less than upper limit of normal) at the time of receiving MM diagnosis
- At least 18 years of age at the time of initiation of 1L treatment
- No documented receipt of a clinical trial treatment for cancer at any time on or after 1/1/2014
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
Official title: Real-World Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden: An Observational Study
This was an observational study utilizing electronic health record (EHR)-derived data collected retrospectively during routine care of real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset.
Read the detailed description
The NOBLE database was built from the harmonization of two customized oncology specific EHR databases: Flatiron Health Spotlight and Concerto Custom Patient360. BRAF v600 mutated advanced (i.e., stage III or IV) patients treated at oncology practices across the US were identified in these two databases for potential inclusion. Both the Flatiron Health EHR-derived database and the Concerto Patient360 database contain clinical, demographic, treatment, and mortality information for melanoma patients from the time of initial diagnosis until death or the most recent data cut-off, which is August 31, 2020 (for population 1), and May 31, 2020 (for population 2).
For population 1 (patients treated in the adjuvant setting): included patients were aged more than or equal to 18 years, were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x), pathologic stage III disease, evidence of resection, adjuvant treatment with Immunotherapy (IO) (e.g., Nivolumab (nivo) or Pembrolizumab (pembro)) or Targeted Therapy (TT) (e.g., Dabrafenib+ Trametinib (dab+tram)) on or after January 1, 2014 and prior to August 30,2020 (data cut-off), and any evidence of a BRAF+ result. Patients were required to have at least 6 months of follow-up after initiation of adjuvant treatment. Patients were followed until the earlier of death, data cut-off, loss of follow-up, or received MM diagnosis. While the first systemic therapy approved for use in the adjuvant melanoma setting occurred in 2015, the study period of interest begins on January 1, 2014, to include any potential off-label use of these therapies as adjuvant therapies.
For population 2 (patients with Low tumor burden (LTB) treated in the metastatic setting): included patients were aged more than or equal to 18 years, and were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), a pathologic stage IV diagnosis, treatment with IO (e.g. Ipilimumab (ipi), nivo, pembro, ipi+nivo) or TT (dab+tram, Vemurafenib+Cobimetinib, Encorafenib+Binimetinib (vem+cobi, enco+bini) on or after January 1, 2014 and prior to May 31, 2020 (data cut-off), and evidence of a BRAF+ result after therapy initiation. Patients were required to be classified as LTB at the time of stage IV diagnosis. LTB was defined as having normal LDH and <3 metastatic sites at the time of stage IV diagnosis. To align with recent FDA approvals for combination therapies use in the MM setting, the study period of interest began on January 1, 2014. Furthermore, this sampling interval allowed for a maximum of 6 years of follow-up from the start of study period.
- Conditions
- Metastatic Melanoma
- Being tested
- Nivolumab, Pembrolizumab, Dabrafenib+Trametinib, Ipilimumab+Nivolumab, Vemurafenib+Cobimetinib
- Keywords
- Adjuvant melanoma,, advanced melanoma,, treatment patterns and outcomes
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Nivolumab
PembrolizumabDrug
Pembrolizumab
Dabrafenib+TrametinibCombination product
Dabrafenib+Trametinib
Ipilimumab+NivolumabCombination product
Ipilimumab+Nivolumab
Vemurafenib+CobimetinibCombination product
Vemurafenib+Cobimetinib
Encorafenib+BinimetinibCombination product
Encorafenib+Binimetinib
| Study group | Role | What they receive |
|---|---|---|
| Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting | Included patients were aged more than or equal to 18 years, were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x), pathologic stage III disease, evidence of resection, adjuvant treatment with IO (e.g., nivo or pembro) or TT (e.g., dab+tram) on or after January 1, 2014, and prior to August 30,2020 (data cut-off), and any evidence of a BRAF+ result. Receives: Drug: Nivolumab; Drug: Pembrolizumab; Combination Product: Dabrafenib+Trametinib | |
| Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting | Included patients were aged more than or equal to 18 years, and were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), a pathologic stage IV diagnosis, treatment with IO (e.g. ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vem+cobi, enco+bini) on or after January 1, 2014 and prior to May 31, 2020 (data cut-off), and evidence of a BRAF+ result after therapy initiation. Patients were required to be classified as LTB at the time of stage IV diagnosis. LTB was defined as having normal LDH and <3 metastatic sites at the time of stage IV diagnosis. Receives: Drug: Nivolumab; Drug: Pembrolizumab; Combination Product: Dabrafenib+Trametinib; Combination Product: Ipilimumab+Nivolumab; Combination Product: Vemurafenib+Cobimetinib; Combination Product: Encorafenib+Binimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients receiving TT and IO therapy in the first-, and second-line
To describe treatment patterns among patients prescribed with TT versus IO in both the populations.
Measured: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Proportion of patients switching from TT 1L therapy to IO 2L therapy
To describe treatment patterns among patients prescribed with TT versus IO in both the populations.
Measured: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Proportion of patients switching from IO 1L therapy to TT 2L therapy
To describe treatment patterns among patients prescribed with TT versus IO in both the populations.
Measured: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Secondary outcomes (5)
Proportion of patients who discontinued treatment in 1L
To evaluate discontinuation of 1L treatment among patients receiving TT or IO.
Measured: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Reasons for discontinuation of treatment in 1L
To evaluate discontinuation of 1L treatment among patients receiving TT or IO.
Measured: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Time from initiation of 1L therapy to death for any reason
To estimate OS from initiation of 1L treatment among patients receiving TT or IO.
Measured: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Time from initiation of 1L therapy to recurrence (for population 1)
To estimate Recurrence Free Survival (RFS) (for population 1) from initiation of 1L treatment among patients receiving TT or IO.
Measured: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020)
Time from initiation of 1L therapy to progression or death (for population 2)
To estimate Progression Free Survival (PFS) (for population 2) from initiation of 1L treatment among patients receiving TT or IO.
Measured: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 31 May 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start16 Jun 2020
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,975 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
- NCT05611229
- Sponsor's protocol ID
- CTMT212AUS55
- Status last verified
- Apr 2023
- First submitted
- 4 Nov 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden: An Observational Study
- ClinicalTrials.gov ID
- NCT05611229
- Acronym / sponsor ID
- CTMT212AUS55
- Conditions
- Metastatic Melanoma
- Keywords
- Adjuvant melanoma,, advanced melanoma,, treatment patterns and outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,975 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 9 Nov 2022 (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 an observational study utilizing electronic health record (EHR)-derived data collected retrospectively during routine care of real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset.
Detailed description
The NOBLE database was built from the harmonization of two customized oncology specific EHR databases: Flatiron Health Spotlight and Concerto Custom Patient360. BRAF v600 mutated advanced (i.e., stage III or IV) patients treated at oncology practices across the US were identified in these two databases for potential inclusion. Both the Flatiron Health EHR-derived database and the Concerto Patient360 database contain clinical, demographic, treatment, and mortality information for melanoma patients from the time of initial diagnosis until death or the most recent data cut-off, which is August 31, 2020 (for population 1), and May 31, 2020 (for population 2).
For population 1 (patients treated in the adjuvant setting): included patients were aged more than or equal to 18 years, were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x), pathologic stage III disease, evidence of resection, adjuvant treatment with Immunotherapy (IO) (e.g., Nivolumab (nivo) or Pembrolizumab (pembro)) or Targeted Therapy (TT) (e.g., Dabrafenib+ Trametinib (dab+tram)) on or after January 1, 2014 and prior to August 30,2020 (data cut-off), and any evidence of a BRAF+ result. Patients were required to have at least 6 months of follow-up after initiation of adjuvant treatment. Patients were followed until the earlier of death, data cut-off, loss of follow-up, or received MM diagnosis. While the first systemic therapy approved for use in the adjuvant melanoma setting occurred in 2015, the study period of interest begins on January 1, 2014, to include any potential off-label use of these therapies as adjuvant therapies.
For population 2 (patients with Low tumor burden (LTB) treated in the metastatic setting): included patients were aged more than or equal to 18 years, and were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), a pathologic stage IV diagnosis, treatment with IO (e.g. Ipilimumab (ipi), nivo, pembro, ipi+nivo) or TT (dab+tram, Vemurafenib+Cobimetinib, Encorafenib+Binimetinib (vem+cobi, enco+bini) on or after January 1, 2014 and prior to May 31, 2020 (data cut-off), and evidence of a BRAF+ result after therapy initiation. Patients were required to be classified as LTB at the time of stage IV diagnosis. LTB was defined as having normal LDH and <3 metastatic sites at the time of stage IV diagnosis. To align with recent FDA approvals for combination therapies use in the MM setting, the study period of interest began on January 1, 2014. Furthermore, this sampling interval allowed for a maximum of 6 years of follow-up from the start of study period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting | – | Drug: Nivolumab, Drug: Pembrolizumab, Combination Product: Dabrafenib+TrametinibIncluded patients were aged more than or equal to 18 years, were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x), pathologic stage III disease, evidence of resection, adjuvant treatment with IO (e.g., nivo or pembro) or TT (e.g., dab+tram) on or after January 1, 2014, and prior to August 30,2020 (data cut-off), and any evidence of a BRAF+ result. |
| Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting | – | Drug: Nivolumab, Drug: Pembrolizumab, Combination Product: Dabrafenib+Trametinib, Combination Product: Ipilimumab+Nivolumab, Combination Product: Vemurafenib+Cobimetinib, Combination Product: Encorafenib+BinimetinibIncluded patients were aged more than or equal to 18 years, and were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), a pathologic stage IV diagnosis, treatment with IO (e.g. ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vem+cobi, enco+bini) on or after January 1, 2014 and prior to May 31, 2020 (data cut-off), and evidence of a BRAF+ result after therapy initiation. Patients were required to be classified as LTB at the time of stage IV diagnosis. LTB was defined as having normal LDH and <3 metastatic sites at the time of stage IV diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset
Key inclusion criteria (18 listed)
- Population 1(patients treated in the adjuvant setting)
- Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x)
- Pathologic stage III on or after 2011
- Evidence of resection
- Adjuvant treatment with IO (nivo, pembro) or TT (dab+tram) on or after 1/1/2014 and prior to 8/31/2020
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabNivolumab | Drug | Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting, Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting |
| PembrolizumabPembrolizumab | Drug | Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting, Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting |
| Dabrafenib+TrametinibDabrafenib+Trametinib | Combination product | Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting, Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting |
| Ipilimumab+NivolumabIpilimumab+Nivolumab | Combination product | Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting |
| Vemurafenib+CobimetinibVemurafenib+Cobimetinib | Combination product | Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting |
| Encorafenib+BinimetinibEncorafenib+Binimetinib | Combination product | Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting |
Primary outcome
Proportion of patients receiving TT and IO therapy in the first-, and second-line
Time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
To describe treatment patterns among patients prescribed with TT versus IO in both the populations.
Proportion of patients switching from TT 1L therapy to IO 2L therapy
Time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
To describe treatment patterns among patients prescribed with TT versus IO in both the populations.
Proportion of patients switching from IO 1L therapy to TT 2L therapy
Time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
To describe treatment patterns among patients prescribed with TT versus IO in both the populations.
5 secondary outcomes
Proportion of patients who discontinued treatment in 1L
Time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Reasons for discontinuation of treatment in 1L
Time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Time from initiation of 1L therapy to death for any reason
Time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2
Time from initiation of 1L therapy to recurrence (for population 1)
Time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020)
Time from initiation of 1L therapy to progression or death (for population 2)
Time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 31 May 2020)
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 6 Apr 2023.
- Results for CTMT212AUS55 from the Novartis Clinical Trials WebsiteLink 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 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 18 inclusion and 1 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 6 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?
Proportion of patients receiving TT and IO therapy in the first-, and second-line (time frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2). The study lists 3 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 6 Apr 2023.