Clinical trial NCT04547946: Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Keywords: Malignant melanoma
Tafinlar
Mekinist
dabrafenib
trametinib
FACT-M questionnaire
generic EQ-5D-3L questionnaire
adjuvant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility 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

  * 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.

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).

Primary outcomes:
measure: Change from baseline in FACT-M score
timeFrame: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16
measure: Change from baseline in EQ-5D-3L score
timeFrame: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16
Secondary outcomes:
measure: Total duration of treatment
timeFrame: months 12
measure: Proportion of patients on treatment in each visit
timeFrame: Baseline, months 3-4, months 6-8, months 9-12, month 12
measure: Rate of permanent study drug discontinuation due to any reason
timeFrame: month 12
measure: Rate of permanent drug discontinuation due to pirexia
timeFrame: month 12
measure: Rate of permanent drug discontinuation due to AEs
timeFrame: month 12
measure: Reason of treatment discontinuation
timeFrame: month 12
measure: Average dose of dabrafenib and trametinib used during the treatment
timeFrame: month 12
measure: Proportion of patients who had dose reduction
timeFrame: month 12
measure: Relapse Free Survival rate
timeFrame: month 12
measure: distant-metastasis-free survival rate
timeFrame: month 12
measure: Overall Survival rate
timeFrame: month 12
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
state: Center
city: Oporto
country: Portugal
facility: Novartis Investigative Site
state: North
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: