Malignant MelanomaNCT04547946
Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)
An observational study of Malignant Melanoma, run by Novartis Pharmaceuticals at 2 sites in Portugal.
Trial summary
The primary objective for this non-interventional study was to assess the quality of life of melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world setting in Portugal through disease specific FACT-M questionnaire and generic EQ-5D-3L questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- dabrafenib + trametinib
- How many people
- 3 participants
- Where
- 2 sitesPortugal
- Study dates
- 15 Oct 2021to 7 Jun 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were recruited from participating centers in the routine setting. This was done only if the decision about starting treatment with darbafenib and trametinib has already been made. All patients that complied with the inclusion criteria and that start treatment with dabrafenib+ trametinib in the participating centers were considered to participate in the study, at investigator discretion.
Who may be able to join
- Patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study
- V600E/K mutation-positive cutaneous melanoma
- Adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) as indicated in the SmPC and by prescription, that has been started before inclusion of the patient into the study;
- ≥ 18 years of age
- Written informed consent signed.
Who cannot join
- Lack of basic demographic (gender, age, age at diagnosis) and staging data (Stage at diagnosis; Breslow index; Clark level; BRAF mutation; BRAF test date; Surgery date).
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Novartis Investigative Site
Coimbra, Center, 3000-075
Novartis Investigative Site
Porto, North, 4200-319
About this study
Official title: Impact of Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib) on Patients Quality of Life (QoL) and Clinical Outcomes in Portuguese Real World Setting
The primary objective for this non-interventional study was to assess the quality of life of melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world setting in Portugal through disease specific FACT-M questionnaire and generic EQ-5D-3L questionnaire. The secondary study objectives were to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that started adjuvant treatment with dabrafenib and trametinib. In addition, this study aimed to explore if treatment discontinuation affects clinical outcomes in real-world practice.
Read the detailed description
The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting was planned to be based on collaboration with 8 centers of excellence on melanoma patients treatment, according to their expertise and experience.
Patients were recruited from participating centers in the routine setting. This was done only if the decision about starting treatment with dabrafenib and trametinib had already been made. All patients that complied with the inclusion criteria and that started treatment with dabrafenib+ trametinib during the recruitment period were considered to participate in the study, at investigator discretion.
Health related quality of life had to be assessed by FACT-M and EQ-5D-3L questionnaires after treatment initiation in a quarterly base, according to clinical practice, including the first visit after treatment completion.
- Conditions
- Malignant Melanoma
- Being tested
- dabrafenib + trametinib
- Keywords
- Malignant melanoma, Tafinlar, Mekinist, dabrafenib, trametinib, FACT-M questionnaire, generic EQ-5D-3L questionnaire, adjuvant
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabrafenib + trametinibDrug
There was no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that had started before inclusion of the patient into the study could be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| dabrafenib + trametinib | Patients administered dabrafenib and trametinib Receives: Drug: dabrafenib + trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in FACT-M score
Health-related quality of life in melanoma patients defined as the mean difference in FACT-M (Functional Assessment of Cancer Therapy - Melanoma ) score.
FACT-M is a specific version of FACT questionnaire validated for patients with any stage of melanoma and includes items related to physical, functional, social and emotional well-being, and specific concerns of melanoma patients and melanoma patients undergoing surgery. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172. Higher scores represent a better quality of life.
Measured: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16
Change from baseline in EQ-5D-3L score
Health-related quality of life in melanoma patients defined as the mean difference in EQ-5D-3L score.
EQ-5D-3L is a descriptive questionnaire comprising five dimensions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels of severity: no problems, some problems, extreme problems. The respondent was asked to indicate his/her health state by checking the box next to the most appropriate response level of each of the five dimensions.
Measured: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16
Secondary outcomes (11)
Total duration of treatment
Total duration of treatment defined as median time on adjuvant treatment (from start to end of treatment/permanent treatment discontinuation).
Measured: months 12
Proportion of patients on treatment in each visit
Proportion of patients on treatment in each visit
Measured: Baseline, months 3-4, months 6-8, months 9-12, month 12
Rate of permanent study drug discontinuation due to any reason
Rate of permanent study drug discontinuation due to any reason.
Measured: month 12
Rate of permanent drug discontinuation due to pirexia
Rate of permanent drug discontinuation due to pirexia over the course of adjuvant treatment.
Measured: month 12
Rate of permanent drug discontinuation due to AEs
Rate of permanent drug discontinuation due to AEs over the course of adjuvant treatment
Measured: month 12
Reason of treatment discontinuation
Reason of treatment discontinuation (death, relapse, AEs, significant change in FACT-M, significant change in EQ-5D-3L , withdrawal of consent, other).
Measured: month 12
Average dose of dabrafenib and trametinib used during the treatment
Average dose of dabrafenib and trametinib used during the treatment, including dose reductions.
Measured: month 12
Proportion of patients who had dose reduction
Percentage of patients with dose reduction during treatment, and in this case, reason for dose reduction
Measured: month 12
Relapse Free Survival rate
RFS (Relapse Free Survival)
Measured: month 12
distant-metastasis-free survival rate
DMFS (distant-metastasis-free survival) rate
Measured: month 12
Overall Survival rate
OS (Overall Survival) rate
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start15 Oct 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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
- Prospective
- Enrolment
- 3 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
- NCT04547946
- Sponsor's protocol ID
- CTMT212APT02
- Status last verified
- May 2023
- First submitted
- 8 Sep 2020
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib) on Patients Quality of Life (QoL) and Clinical Outcomes in Portuguese Real World Setting
- ClinicalTrials.gov ID
- NCT04547946
- Acronym / sponsor ID
- CTMT212APT02
- Conditions
- Malignant Melanoma
- Keywords
- Malignant melanoma, Tafinlar, Mekinist, dabrafenib, trametinib, FACT-M questionnaire, generic EQ-5D-3L questionnaire, adjuvant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 14 Sep 2020 (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 primary objective for this non-interventional study was to assess the quality of life of melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world setting in Portugal through disease specific FACT-M questionnaire and generic EQ-5D-3L questionnaire. The secondary study objectives were to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that started adjuvant treatment with dabrafenib and trametinib. In addition, this study aimed to explore if treatment discontinuation affects clinical outcomes in real-world practice.
Detailed description
The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting was planned to be based on collaboration with 8 centers of excellence on melanoma patients treatment, according to their expertise and experience.
Patients were recruited from participating centers in the routine setting. This was done only if the decision about starting treatment with dabrafenib and trametinib had already been made. All patients that complied with the inclusion criteria and that started treatment with dabrafenib+ trametinib during the recruitment period were considered to participate in the study, at investigator discretion.
Health related quality of life had to be assessed by FACT-M and EQ-5D-3L questionnaires after treatment initiation in a quarterly base, according to clinical practice, including the first visit after treatment completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dabrafenib + trametinib | – | Drug: dabrafenib + trametinibPatients administered dabrafenib and trametinib |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from participating centers in the routine setting. This was done only if the decision about starting treatment with darbafenib and trametinib has already been made. All patients that complied with the inclusion criteria and that start treatment with dabrafenib+ trametinib in the participating centers were considered to participate in the study, at investigator discretion.
Key inclusion criteria (5 listed)
- Patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study
Key exclusion criteria (1 listed)
- Lack of basic demographic (gender, age, age at diagnosis) and staging data (Stage at diagnosis; Breslow index; Clark level; BRAF mutation; BRAF test date; Surgery date).
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 |
|---|---|---|
| dabrafenib + trametinibThere was no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that had started before inclusion of the patient into the study could be enrolled. | Drug | dabrafenib + trametinib |
Primary outcome
Change from baseline in FACT-M score
Time frame: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16
Health-related quality of life in melanoma patients defined as the mean difference in FACT-M (Functional Assessment of Cancer Therapy - Melanoma ) score. FACT-M is a specific version of FACT questionnaire validated for patients with any stage of melanoma and includes items related to physical, functional, social and emotional well-being, and specific concerns of melanoma patients and melanoma patients undergoing surgery. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172. Higher scores represent a better quality of life.
Change from baseline in EQ-5D-3L score
Time frame: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16
Health-related quality of life in melanoma patients defined as the mean difference in EQ-5D-3L score. EQ-5D-3L is a descriptive questionnaire comprising five dimensions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels of severity: no problems, some problems, extreme problems. The respondent was asked to indicate his/her health state by checking the box next to the most appropriate response level of each of the five dimensions.
11 secondary outcomes
Total duration of treatment
Time frame: months 12
Proportion of patients on treatment in each visit
Time frame: Baseline, months 3-4, months 6-8, months 9-12, month 12
Rate of permanent study drug discontinuation due to any reason
Time frame: month 12
Rate of permanent drug discontinuation due to pirexia
Time frame: month 12
Rate of permanent drug discontinuation due to AEs
Time frame: month 12
Reason of treatment discontinuation
Time frame: month 12
Average dose of dabrafenib and trametinib used during the treatment
Time frame: month 12
Proportion of patients who had dose reduction
Time frame: month 12
Relapse Free Survival rate
Time frame: month 12
distant-metastasis-free survival rate
Time frame: month 12
Overall Survival rate
Time frame: month 12
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 30 May 2023.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Melanoma, run by Novartis Pharmaceuticals at 2 sites in Portugal.
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 5 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 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Change from baseline in FACT-M score (time frame: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16). The study lists 2 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 30 May 2023.