Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)
Study Details
Study Description
Brief Summary
The primary objective for this non-interventional study is 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 are to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that start adjuvant treatment with dabrafenib and trametinib. In addition, this study aims to explore if treatment discontinuation affects clinical outcomes in real-world practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting will be based on collaboration with 8 centers of excellence on melanoma patients treatment, according to their expertise and experience.
Patients will be recruited from participating centers in the routine setting. This will be done only if the decision about starting treatment with dabrafenib and trametinib has already been made. All patients that comply with the inclusion criteria and that start treatment with dabrafenib+ trametinib during the recruitment period will be considered to participate in the study, at investigator discretion.
Health related quality of life will be assessed by FACT-M and EQ-5D-3L questionnaire after treatment initiation in a quarterly base, according to clinical practice, including the first visit after treatment completion.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| dabrafenib + trametinib Patients administered dabrafenib and trametinib |
Drug: dabrafenib + trametinib
There is no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that have started before inclusion of the patient into the study will be enrolled.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in FACT-M score [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 [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 is asked to indicate his/her health state by checking the box next to the most appropriate response level of each of the five dimensions.
Secondary Outcome Measures
- Total duration of treatment [months 12]
Total duration of treatment defined as median time on adjuvant treatment (from start to end of treatment/permanent treatment discontinuation).
- Proportion of patients on treatment in each visit [Baseline, months 3-4, months 6-8, months 9-12, month 12]
Proportion of patients on treatment in each visit
- Rate of permanent study drug discontinuation due to any reason [month 12]
Rate of permanent study drug discontinuation due to any reason.
- Rate of permanent drug discontinuation due to pirexia [month 12]
Rate of permanent drug discontinuation due to pirexia over the course of adjuvant treatment.
- Rate of permanent drug discontinuation due to AEs [month 12]
Rate of permanent drug discontinuation due to AEs over the course of adjuvant treatment
- Reason of treatment discontinuation [month 12]
Reason of treatment discontinuation (death, relapse, AEs, significant change in FACT-M, significant change in EQ-5D-3L , withdrawal of consent, other).
- Average dose of dabrafenib and trametinib used during the treatment [month 12]
Average dose of dabrafenib and trametinib used during the treatment, including dose reductions.
- Proportion of patients who had dose reduction [month 12]
Percentage of patients with dose reduction during treatment, and in this case, reason for dose reduction
- Relapse Free Survival rate [month 12]
RFS (Relapse Free Survival)
- distant-metastasis-free survival rate [month 12]
DMFS (distant-metastasis-free survival) rate
- Overall Survival rate [month 12]
OS (Overall Survival) rate
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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V600E/K mutation-positive cutaneous melanoma
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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;
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≥ 18 years of age
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Written informed consent signed.
Exclusion Criteria:
- 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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Coimbra | Center | Portugal | 3000-075 |
| 2 | Novartis Investigative Site | Lisbon | Lisbon And Tagus Valley | Portugal | 1649-035 |
| 3 | Novartis Investigative Site | Oporto | North | Portugal | 4200-319 |
| 4 | Novartis Investigative Site | Funchal | Região Autónoma Da Madeira | Portugal | 9000-177 |
| 5 | Novartis Investigative Site | Setúbal | South | Portugal | 2900-722 |
| 6 | Novartis Investigative Site | Évora | South | Portugal | 7000-811 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTMT212APT02