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Status unknownNCT05510466Updated Aug 22, 2022

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

An observational study in Metastatic Melanoma, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-22.

Sponsored by University Hospital, Montpellier · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
18
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metastatic Melanoma

Keywords

  • Initially treated by a doubled targeted therapy anti BRAF/anti MEK
  • immunotherapy
  • combined tritherapy
  • melanoma's brain metastasis
  • With an intra cerebral progression of the tumor
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 18 is below the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion criteria:

  • Other condition
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
18 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. comparison between intra and extra cerebral metastasis

    comparison between intra and extra cerebral metastasis

    Time frame: day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05510466
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Aug 22, 2022
Start date
Jan 1, 2019
Primary completion
Feb 20, 2023 (estimated)
Completion
Mar 1, 2023 (estimated)
Last update
Aug 22, 2022

Study contacts

Olivier DEREURE, MD, PhD
Contact
o-dereure@chu-montpellier.fr
467336906 ext. 33
Marie Louise Jeanne, resident
Contact
Marie Louise Jeanne, resident
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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