Ignite Creation Date:
2024-05-06 @ 12:58 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03898908
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-18
First Post:
2019-03-27
Brief Title:
Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain
Sponsor:
Grupo Español Multidisciplinar de Melanoma
Organization:
Grupo Español Multidisciplinar de Melanoma
Study Overview
Official Title:
Phase II Multicentre Clinical Trial to Evaluate the Activity of Encorafenib and Binimetinib Administered Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EBRAIN-MEL
Brief Summary:
Phase II clinical trial with two cohorts of patients included in parallel all with melanoma BRAF mutated and brain metastases without previous local treatment in the brain Cohort 1 will include patients with asymptomatic brain metastases and cohort 2 will include patients with symptomatic brain metastasis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002530-20 | EUDRACT_NUMBER | None | None |