Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patien... | NCT05510466

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

NCT05510466

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Aug 22, 2022Actual

Enrollment

18Estimated

Phase

Not provided

Conditions

Metastatic Melanoma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Feb 20, 2023Estimated

Completion Date

Mar 1, 2023Estimated

First Submitted Date

Jan 25, 2022

First Submission Date that Met QC Criteria

Aug 19, 2022

First Posted Date

Aug 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2022

Last Update Posted Date

Aug 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olivier DEREURE, MD, PhD	Contact	467336906	33	o-dereure@chu-montpellier.fr
Marie Louise Jeanne, resident	Contact

Overall Officials

Name	Affiliation	Role
Marie Louise Jeanne, resident	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided