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NCT05510466 Clinical Trial

Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis

Metastatic Melanoma Clinical Trial

Official title:
Analysis of Efficiency and Tolerance of Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis Occuring During First-line BRAFinh/MEKinh Therapy.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05510466
Other study ID # RECHMPL22_0016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date March 1, 2023

Study information
Verified date January 2022
Source University Hospital, Montpellier
Contact Olivier DEREURE, MD, PhD
Phone 467336906
Email o-dereure@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Currently, therapeutic options in BRAF mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (TT) are limited. In this setting, the addition of an anti PD1 agent to TT may be proposed as a second line strategy. This observational survey aims at investigating the benefit/risk ratio of this triple combination in a small cohort of patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date March 1, 2023
Est. primary completion date February 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Metastatic melanoma BRAF mutated - Initially treated by a doubled targeted therapy anti BRAF/anti MEK - With an intra cerebral progression of the tumor - Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy - between 01/2019 et 01/2022 Exclusion criteria: - Other condition

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary comparison between intra and extra cerebral metastasis comparison between intra and extra cerebral metastasis day 1
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