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

Metastatic Melanoma Clinical Trial

— TOLBRIPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155217
• Other study ID #: RECHMPL17_0048
• Status: Completed
• Start date: May 5, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• Metastatic melanoma

Exclusion Criteria:

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	grade 3-4 adverse effects	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	1 day
Secondary	Treatment modification	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.	1 day