Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207656
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-12-27
Brief Title:
Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer
Sponsor:
Spanish Cooperative Group for the Treatment of Digestive Tumours TTD
Organization:
Spanish Cooperative Group for the Treatment of Digestive Tumours TTD
Study Overview
Official Title:
Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
CEBBRA
Brief Summary:
As a result of the little benefit obtained from standard treatments and the poor prognosis of these patients the BRAF-V600E mutant MSS aCRC represents an unmet medical need requiring clinical research
The combination of encorafenib cetuximab and binimetinib as second- or third-line treatment for mCRC resulted in significantly better outcomes than standard therapy in a phase 3 clinical trial which also revealed treatment safety and tolerability to be acceptable Compared to the control group cetuximab and irinotecan or cetuximab and FOLFIRI the triplet therapy cohort showed higher median overall survival 93 vs 59 months and response rates 268 vs 18 Grade 3 adverse events occurred in 658 and 642 of patients for triple-therapy and control groups respectively
Based on these results the investigators speculated that the combination of encorafenib cetuximab and binimetinib could be used as induction therapy to improve treatment outcomes in BRAF-V600E-mutated MSS aCRC locally advanced initially unresectable but potentially resectable initially resectable or initially unresectable but potentially resectable oligometastatic disease and in patients with stage II-IV who have relapsed after chemotherapy neo andor adjuvant or surgery if the shorter time after resection or from treatment end to relapse is longer than 6 months
The combination of encorafenib cetuximab and binimetinib as second- or third-line treatment for mCRC resulted in significantly better outcomes than standard therapy in a phase 3 clinical trial which also revealed treatment safety and tolerability to be acceptable Compared to the control group cetuximab and irinotecan or cetuximab and FOLFIRI the triplet therapy cohort showed higher median overall survival 93 vs 59 months and response rates 268 vs 18 Grade 3 adverse events occurred in 658 and 642 of patients for triple-therapy and control groups respectively
Based on these results the investigators speculated that the combination of encorafenib cetuximab and binimetinib could be used as induction therapy to improve treatment outcomes in BRAF-V600E-mutated MSS aCRC locally advanced initially unresectable but potentially resectable initially resectable or initially unresectable but potentially resectable oligometastatic disease and in patients with stage II-IV who have relapsed after chemotherapy neo andor adjuvant or surgery if the shorter time after resection or from treatment end to relapse is longer than 6 months
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