Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)

NCT04547946 | Completed

• 1 other identifier: CTMT212APT02
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Melanoma

Keywords

Malignant melanoma; Tafinlar; Mekinist; dabrafenib; trametinib; FACT-M questionnaire; generic EQ-5D-3L questionnaire; adjuvant

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16

Secondary Outcomes (11)

• Total duration of treatment

  months 12

• Proportion of patients on treatment in each visit

  Baseline, months 3-4, months 6-8, months 9-12, month 12

• Rate of permanent study drug discontinuation due to any reason

  month 12

• Rate of permanent drug discontinuation due to pirexia

  month 12

• Rate of permanent drug discontinuation due to AEs

  month 12

Study Arms (1)

dabrafenib + trametinib

Patients administered dabrafenib and trametinib

Drug: dabrafenib + trametinib

Interventions

dabrafenib + trametinib DRUG

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.

dabrafenib + trametinib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• ≥ 18 years of age
• Written informed consent signed.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Coimbra, Center, 3000-075, Portugal

Location

Novartis Investigative Site

Porto, North, 4200-319, Portugal

Location

MeSH Terms

Conditions

Melanoma

Interventions

dabrafenib; trametinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: October 15, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)