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

August 19, 2022 updated by: University Hospital, Montpellier

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.

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Marie Louise Jeanne, resident

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between intra and extra cerebral metastasis
Time Frame: day 1
comparison between intra and extra cerebral metastasis
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Marie Louise Jeanne, resident, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

February 20, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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