Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05510895
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2022-08-17
Brief Title:
Neoadjuvant Encorafenib Binimetinib and Cetuximab for Patients With BRAF V600E MutatedpMMR Localized Colorectal Cancer
Sponsor:
AIO-Studien-gGmbH
Organization:
AIO-Studien-gGmbH
Study Overview
Official Title:
Neoadjuvant Encorafenib Binimetinib and Cetuximab for Patients With BRAF V600E MutatedpMMR Localized Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2023-06
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:
NeoBRAF
Brief Summary:
AIO-KRK-0420 NeoBRAF is a single arm multicenter phase II trial with neoadjuvant encorafenib binimetinib and cetuximab for patients with BRAF V600E mutatedpMMR localized colorectal cancer
Detailed Description:
This is a single arm multicenter phase II trial for patients with unresected BRAF V600E mutatedpMMR localized colorectal cancer CRC Patients enrolled will be treated with neoadjuvant encorafenib 300mg QD binimetinib 45mg BID and cetuximab 500mgm² biweekly for 8 weeks Neoadjuvant treatment will be followed by surgery First Endpoint is TRG Tumor-Regression-Grade which will be analyzed centrally Patients with TRG1 will receive adjuvant treatment with encorafenib 300mg QD binimetinib 45mg BID and cetuximab 500mgm² biweekly for up to 16 weeks For patients with TRG2 EOT will be reached 4-6 weeks after last dosage of encorafenib binimetinib and cetuximab and further treatment is at investigator discretion CAPOX recommended All subjects will be followed every 3 months after surgery for up to 4 years after start of recruitment
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