A Prospective Observational Study on Targeted Therapy for Unresectable or Metastatic BRAFV600E Mutant Melanoma Patients

NCT04911998 | Completed DMC

• 1 other identifier: NIS-PFO-2020-3501
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

• To assess the use of TavieSkin app in patients with unresectable or metastatic BRAF-mutated melanoma treated with BRAFi/MEKi combination;
• To assess the treatment adherence of patients using TavieSkin app including treatment interruption or permanent discontinuation;
• To assess the health-related quality of life of patients using TavieSkin app (FACT-M);
• To assess work productivity and activity impairment over the treatment duration
• To assess the patient satisfaction toward the TavieSkin application;
• To assess the patient satisfaction toward the treatment.
• Research methods

Conditions

Melanoma (Skin); Metastatic Melanoma; BRAF V600 Mutation

Keywords

Melanoma; BRAFV600; Targeted therapy; BRAFi/MEKi; Non-interventional study; Metastatic

Outcome Measures

Primary Outcomes (13)

• Description of age

  Age will be assessed in years (date of the initiation of targeted therapy - date of birth)

  Baseline

• Description of Sex

  Sex will be described in percentage of Male and Female among the participants

  Baseline

• Description of BMI

  Weight (in kg) and height (in m) will be combined to report BMI in kg/m2

  Baseline

• Description of sociodemographic status: country

  The country will be described in number of participants included in each country (France, Portugal, Spain, Belgium, Germany, Italy)

  Baseline

• Description of sociodemographic status: education level

  The education level will be described by the following distribution of participants: with no degree/Primary education, High school level or equivalent and with college degree (i.e. Bachelor, Master or Doctorate)

  Baseline

• Description of sociodemographic status: employment status

  The employment status will be described by the following distribution of participants: employed, unemployed, retired and student

  Baseline

• Description of sociodemographic status: living place

  The living place will be described by the following distribution of participants: living in urban/suburban and in rural

  Baseline

• Description of sociodemographic status: family situation

  The family situation will be described by the following distribution of participants: living alone, cohabiting or living with family members and other

  Baseline

• Description of clinical characteristics of patients: time since initial diagnostic of melanoma

  The time since initial diagnostic of melanoma will be assessed in number of years (date of the initiation of targeted therapy - date of initial diagnostic of melanoma)

  Baseline

• Description of clinical characteristics of patients: time since metastatic diagnosis

  The time since metastatic diagnosis will be assessed in number of years (date of the initiation of targeted therapy - date of metastatic diagnosis)

  Baseline

• Description of clinical characteristics of patients: initial/primary site of tumor

  The Initial/primary site of tumor will be described by the following distribution of participants: with localization in the upper extremities, head and neck, trunk, lower extremities, mucosal or uvea, unknown localization

  Baseline

• Description of clinical characteristics of patients: comorbidities

  The comorbidities will be described by the following distribution of participants: with diabetes, hypertension, renal failure, cardiovascular disease, other cancer, autoimmune disease, …

  Baseline

• Description of clinical characteristics of patients: prior therapies for melanoma

  The prior therapies for melanoma will be described by the following distribution of participants: treated with surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, other

  Baseline

Secondary Outcomes (9)

• Assessment of the use of TavieSkin application:number of subscribers who frequently use the application

  Every day during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first

• Assessment of the use of TavieSkin application: duration of usage per day

  Every day during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first

• Assessment of the use of TavieSkin application: rate of completed data and completed questionnaires

  Every day during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first

• Assessment of the adherence to treatment

  Every day during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first

• Assessment of health-related quality of life.

  Baseline, then every 6 weeks during targeted therapy until targeted therapy discontinuation or study completion, an average of 1 year, whichever comes first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with BRAF-mutant (documented as per routine practice) unresectable or metastatic melanoma in the target countries (France, Portugal, Belgium, Spain, Germany, Italy) and initiating BRAFi/MEKi combination therapy will be invited by its healthcare provider (i.e. oncologist, dermatologist, nurse…) to use the TavieSkin app during a routine visit.

You may qualify if:

• Only patients starting to use the TavieSkin app will be eligible for enrollment in the survey.
• Male or female aged ≥18 years at diagnosis of unresectable or metastatic melanoma;
• Diagnosis of histologically or cytologically confirmed BRAF-mutant melanoma that is metastatic or unresectable, documented as per routine practice
• Patient having an ongoing prescription of one of the three commercially available BRAFi/MEKi combination therapy, at any line of treatment
• Patient using the TavieSkin app and having signed an informed consent (e-consent via the app) for data collection , according to local regulations

You may not qualify if:

• Patients will be excluded from the survey if they fulfil any of the following criteria:
• Patients with other BRAFi/MEKi combination than those available on the market
• Patient receiving a BRAFi/MEKi combination in the adjuvant setting
• Patients under guardianship because of mental illness or any other reason
• Patients treated with a treatment that is not licensed for local use (including approved BRAFi/MEKi combination associated with another product)

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (1)

Hospital Evora

Evora, Portugal

Location

Related Publications (25)

• Miller AJ, Mihm MC Jr. Melanoma. N Engl J Med. 2006 Jul 6;355(1):51-65. doi: 10.1056/NEJMra052166. No abstract available.

  PMID: 16822996 BACKGROUND

• Potrony M, Badenas C, Aguilera P, Puig-Butille JA, Carrera C, Malvehy J, Puig S. Update in genetic susceptibility in melanoma. Ann Transl Med. 2015 Sep;3(15):210. doi: 10.3978/j.issn.2305-5839.2015.08.11.

  PMID: 26488006 BACKGROUND

• Ryu S, Youn C, Moon AR, Howland A, Armstrong CA, Song PI. Therapeutic Inhibitors against Mutated BRAF and MEK for the Treatment of Metastatic Melanoma. Chonnam Med J. 2017 Sep;53(3):173-177. doi: 10.4068/cmj.2017.53.3.173. Epub 2017 Sep 25.

  PMID: 29026704 BACKGROUND

• Moreau S, Saiag P, Aegerter P, Bosset D, Longvert C, Helias-Rodzewicz Z, Marin C, Peschaud F, Chagnon S, Zimmermann U, Clerici T, Emile JF. Prognostic value of BRAF(V(6)(0)(0)) mutations in melanoma patients after resection of metastatic lymph nodes. Ann Surg Oncol. 2012 Dec;19(13):4314-21. doi: 10.1245/s10434-012-2457-5. Epub 2012 Jul 7.

  PMID: 22772867 BACKGROUND

• Rutkowski P, Gos A, Jurkowska M, Switaj T, Dziewirski W, Zdzienicki M, Ptaszynski K, Michej W, Tysarowski A, Siedlecki JA. Molecular alterations in clinical stage III cutaneous melanoma: Correlation with clinicopathological features and patient outcome. Oncol Lett. 2014 Jul;8(1):47-54. doi: 10.3892/ol.2014.2122. Epub 2014 May 8.

  PMID: 24959217 BACKGROUND

• Arance Fernández, A. M. et al. Epidemiological study to evaluate the prevalence of BRAF V600 mutation in patients (pts) diagnosed with advanced melanoma (AM) in routine clinical practice in Spain. J. Clin. Oncol. 33, e20115-e20115 (2015). DOI:10.1200/jco.2015.33.15_suppl.e20115

  BACKGROUND

• Picard M, Pham Dang N, D'Incan M, Mansard S, Dechelotte P, Pereira B, Mondie JM, Barthelemy I. Is BRAF a prognostic factor in stage III skin melanoma? A retrospective study of 72 patients after positive sentinel lymph node dissection. Br J Dermatol. 2014 Jul;171(1):108-14. doi: 10.1111/bjd.12939. Epub 2014 Jul 7.

  PMID: 24602025 BACKGROUND

• Colombino M, Lissia A, Capone M, De Giorgi V, Massi D, Stanganelli I, Fonsatti E, Maio M, Botti G, Caraco C, Mozzillo N, Ascierto PA, Cossu A, Palmieri G. Heterogeneous distribution of BRAF/NRAS mutations among Italian patients with advanced melanoma. J Transl Med. 2013 Aug 29;11:202. doi: 10.1186/1479-5876-11-202.

  PMID: 23987572 BACKGROUND

• Carlino MS, Haydu LE, Kakavand H, Menzies AM, Hamilton AL, Yu B, Ng CC, Cooper WA, Thompson JF, Kefford RF, O'Toole SA, Scolyer RA, Long GV. Correlation of BRAF and NRAS mutation status with outcome, site of distant metastasis and response to chemotherapy in metastatic melanoma. Br J Cancer. 2014 Jul 15;111(2):292-9. doi: 10.1038/bjc.2014.287. Epub 2014 Jun 10.

  PMID: 24918823 BACKGROUND

• Ekedahl H, Cirenajwis H, Harbst K, Carneiro A, Nielsen K, Olsson H, Lundgren L, Ingvar C, Jonsson G. The clinical significance of BRAF and NRAS mutations in a clinic-based metastatic melanoma cohort. Br J Dermatol. 2013 Nov;169(5):1049-55. doi: 10.1111/bjd.12504.

  PMID: 23855428 BACKGROUND

• Long GV, Menzies AM, Nagrial AM, Haydu LE, Hamilton AL, Mann GJ, Hughes TM, Thompson JF, Scolyer RA, Kefford RF. Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma. J Clin Oncol. 2011 Apr 1;29(10):1239-46. doi: 10.1200/JCO.2010.32.4327. Epub 2011 Feb 22.

  PMID: 21343559 BACKGROUND

• Svedman FC, Pillas D, Taylor A, Kaur M, Linder R, Hansson J. Stage-specific survival and recurrence in patients with cutaneous malignant melanoma in Europe - a systematic review of the literature. Clin Epidemiol. 2016 May 26;8:109-22. doi: 10.2147/CLEP.S99021. eCollection 2016.

  PMID: 27307765 BACKGROUND

• Schoffer O, Schulein S, Arand G, Arnholdt H, Baaske D, Bargou RC, Becker N, Beckmann MW, Bodack Y, Bohme B, Bozkurt T, Breitsprecher R, Buchali A, Burger E, Burger U, Dommisch K, Elsner G, Fernschild K, Flintzer U, Funke U, Gerken M, Gobel H, Grobe N, Gumpp V, Heinzerling L, Kempfer LR, Kiani A, Klinkhammer-Schalke M, Klocking S, Kreibich U, Knabner K, Kuhn P, Lutze S, Mader U, Maisel T, Maschke J, Middeke M, Neubauer A, Niedostatek A, Opazo-Saez A, Peters C, Schell B, Schenkirsch G, Schmalenberg H, Schmidt P, Schneider C, Schubotz B, Seide A, Strecker P, Taubenheim S, Wackes M, Weiss S, Welke C, Werner C, Wittekind C, Wulff J, Zettl H, Klug SJ. Tumour stage distribution and survival of malignant melanoma in Germany 2002-2011. BMC Cancer. 2016 Dec 5;16(1):936. doi: 10.1186/s12885-016-2963-0.

  PMID: 27919243 BACKGROUND

• Jochems A, Schouwenburg MG, Leeneman B, Franken MG, van den Eertwegh AJ, Haanen JB, Gelderblom H, Uyl-de Groot CA, Aarts MJ, van den Berkmortel FW, Blokx WA, Cardous-Ubbink MC, Groenewegen G, de Groot JW, Hospers GA, Kapiteijn E, Koornstra RH, Kruit WH, Louwman MW, Piersma D, van Rijn RS, Ten Tije AJ, Vreugdenhil G, Wouters MW, van der Hoeven JJ. Dutch Melanoma Treatment Registry: Quality assurance in the care of patients with metastatic melanoma in the Netherlands. Eur J Cancer. 2017 Feb;72:156-165. doi: 10.1016/j.ejca.2016.11.021. Epub 2016 Dec 25.

  PMID: 28030784 BACKGROUND

• Gershenwald JE, Scolyer RA, Hess KR, Sondak VK, Long GV, Ross MI, Lazar AJ, Faries MB, Kirkwood JM, McArthur GA, Haydu LE, Eggermont AMM, Flaherty KT, Balch CM, Thompson JF; for members of the American Joint Committee on Cancer Melanoma Expert Panel and the International Melanoma Database and Discovery Platform. Melanoma staging: Evidence-based changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017 Nov;67(6):472-492. doi: 10.3322/caac.21409. Epub 2017 Oct 13.

  PMID: 29028110 BACKGROUND

• Hinz A, Singer S, Brahler E. European reference values for the quality of life questionnaire EORTC QLQ-C30: Results of a German investigation and a summarizing analysis of six European general population normative studies. Acta Oncol. 2014 Jul;53(7):958-65. doi: 10.3109/0284186X.2013.879998. Epub 2014 Jan 23.

  PMID: 24456505 BACKGROUND

• Michielin O, van Akkooi ACJ, Ascierto PA, Dummer R, Keilholz U; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-updagger. Ann Oncol. 2019 Dec 1;30(12):1884-1901. doi: 10.1093/annonc/mdz411. No abstract available.

  PMID: 31566661 BACKGROUND

• Osborn J, Ajakaiye A, Cooksley T, Subbe CP. Do mHealth applications improve clinical outcomes of patients with cancer? A critical appraisal of the peer-reviewed literature. Support Care Cancer. 2020 Mar;28(3):1469-1479. doi: 10.1007/s00520-019-04945-4. Epub 2019 Jul 4.

  PMID: 31273501 BACKGROUND

• McKay FH, Cheng C, Wright A, Shill J, Stephens H, Uccellini M. Evaluating mobile phone applications for health behaviour change: A systematic review. J Telemed Telecare. 2018 Jan;24(1):22-30. doi: 10.1177/1357633X16673538. Epub 2016 Oct 18.

  PMID: 27760883 BACKGROUND

• Haase J, Farris KB, Dorsch MP. Mobile Applications to Improve Medication Adherence. Telemed J E Health. 2017 Feb;23(2):75-79. doi: 10.1089/tmj.2015.0227. Epub 2016 Jun 1.

  PMID: 27248315 BACKGROUND

• Iribarren SJ, Cato K, Falzon L, Stone PW. What is the economic evidence for mHealth? A systematic review of economic evaluations of mHealth solutions. PLoS One. 2017 Feb 2;12(2):e0170581. doi: 10.1371/journal.pone.0170581. eCollection 2017.

  PMID: 28152012 BACKGROUND

• Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.

  PMID: 10146874 BACKGROUND

• Henshall C, Davey Z, Jacelon C, Martin C. A usability study to test the effectiveness, efficiency and simplicity of a newly developed Internet-based Exercise-focused Health App for Lung cancer survivors (iEXHALE): Protocol paper. Health Informatics J. 2020 Jun;26(2):1431-1442. doi: 10.1177/1460458219882268. Epub 2019 Oct 21.

  PMID: 31631739 BACKGROUND

• Sauro, J. A practical guide to the system usability scale: background, benchmarks & best practices. Denver, CO: Measuring Usability LLC, 2011

  BACKGROUND

• Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004 Feb 26;2:12. doi: 10.1186/1477-7525-2-12.

  PMID: 14987333 BACKGROUND

Related Links

• Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Meyer, MD, PhD

  Head of Skin Cancer Unit, Toulouse University Cancer Institute, CHU Larrey et Oncopôle, France

  STUDY CHAIR

• Peter Mohr, MD

  Department of Dermatology, Elbe Kliniken, Buxtehude, Germany

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: June 3, 2021
• Study Start: February 2, 2021
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

PT (1)