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NCT Number: NCT03155217

Tolerance of Targeted Therapy Used in Metastatic Melanoma in Patients Aged Over 65 and 75-year-old

Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the over-75-year-old age group is becoming larger. These patients are still active but much more vulnerable. Nevertheless, there is no data in the literature for this fragile population except the MM pivotal studies subgroups of those over 65-year-old. The results vary with different regimens. Therefore, there is a wide lack of information that could help make a therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK inhibitors in elderly patients

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Key information

About this study

Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the over-75-year-old age group is becoming larger. These patients are still active but much more vulnerable. Nevertheless, there is no data in the literature for this fragile population except the MM pivotal studies subgroups of those over 65-year-old. The results vary with different regimens. Therefore, there is a wide lack of information that could help make a therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK inhibitors in elderly patients. This work aims to study the targeted therapies tolerance in over 65 or 75-year-old patients with BRAF mutated MM. The French clinical and biological database MELBASE will be analysed to carry out a descriptive retrospective multicentric study. This real-life assessment of the adverse effects in older patients will result in more adapted therapeutic decisions, better informed patients and improved follow-up care in order to increase quality of life and life expectancy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic melanoma

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. grade 3-4 adverse effects

    Time frame: 1 day

    Analyze the relationship between Grade 3 and Level 4 adverse events in subjects older than 65 or 75 years of age compared to patients under 65 years of age

Secondary outcomes

  1. Treatment modification

    Time frame: 1 day

    Analyze treatment changes with progression-free survival and overall follow-up in patients over 65 or 75 years of age compared to patients younger than 65 years.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Saint-Louis Hospital, Paris, France

Registry information

Official study title

Safety of Targeted Therapies in Elderly Patients (Over 5 and 75 Year-old) With Metastatic Melanoma

Acronym: TOLBRIPA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2017
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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