NCT05510466

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 22, 2022

Status Verified

January 1, 2022

Enrollment Period

4.1 years

First QC Date

January 25, 2022

Last Update Submit

August 19, 2022

Conditions

Metastatic Melanoma

Keywords

Initially treated by a doubled targeted therapy anti BRAF/anti MEKimmunotherapycombined tritherapymelanoma's brain metastasisWith an intra cerebral progression of the tumor

Outcome Measures

Primary Outcomes (1)

  • comparison between intra and extra cerebral metastasis

    comparison between intra and extra cerebral metastasis

    day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • \- Other condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Marie Louise Jeanne, resident

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier DEREURE, MD, PhD

CONTACT

467336906o-dereure@chu-montpellier.fr

Marie Louise Jeanne, resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

August 22, 2022

Study Start

January 1, 2019

Primary Completion

February 20, 2023

Study Completion

March 1, 2023

Last Updated

August 22, 2022

Record last verified: 2022-01

Locations

FR(1)