Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411600
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-24
Brief Title:
Combination Therapy for BRAF-V600E Metastatic CRCm
Sponsor:
Vall dHebron Institute of Oncology
Organization:
Vall dHebron Institute of Oncology
Study Overview
Official Title:
Bevacizumab Plus encoRAfenib-cetuximab in BRAF-V600E Mutated Metastatic Colorectal Cancer a Phase II Study With a Safety lead-in Cohort the BRAVE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
BRAVE
Brief Summary:
The BRAVE is a phase II clinical trial aimed at evaluating the efficacy of the combination therapy of encorafenib cetuximab and bevacizumab in patients with metastatic colorectal cancer CRC harboring the BRAF-V600E mutation This mutation is present in about 8-10 of CRC cases and is associated with poor prognosis and limited treatment options The rationale behind this trial stems from preclinical studies suggesting that the overexpression and activation of vascular endothelial growth factor A VEGFA may contribute to resistance to BRAF inhibitors BRAFi in CRC Thus the trial hypothesizes that adding bevacizumab an anti-angiogenic agent targeting VEGFA to the combination of encorafenib and cetuximab may delay acquired resistance leading to improved progression-free survival
The primary objective of the BRAVE is to evaluate the antitumor activity of the encorafenib-cetuximab-bevacizumab combination in patients who have experienced disease progression after one or two chemotherapy regimens for BRAF V600E-mutant metastatic CRC This activity will be assessed based on the confirmed progression-free survival rate according to Response Evaluation Criteria in Solid Tumors RECIST version 11 criteria
The primary objective of the BRAVE is to evaluate the antitumor activity of the encorafenib-cetuximab-bevacizumab combination in patients who have experienced disease progression after one or two chemotherapy regimens for BRAF V600E-mutant metastatic CRC This activity will be assessed based on the confirmed progression-free survival rate according to Response Evaluation Criteria in Solid Tumors RECIST version 11 criteria
Detailed Description:
Study Design The study adopts a multicenter open-label phase II design Patients with metastatic CRC harboring the BRAF-V600E mutation who have experienced disease progression after one or two prior chemotherapy regimens are eligible for enrollment The treatment regimen consists of daily oral encorafenib 300 mg biweekly intravenous cetuximab 500 mgm2 and biweekly intravenous bevacizumab 5 mgkg Treatment will be administered in 28-day cycles until disease progression unacceptable toxicity consent withdrawal initiation of other anticancer therapy or death
Secondary Objectives Secondary objectives include evaluating the safety and tolerability of the combination therapy assessing objective response rate time to response duration of response overall survival and patient-reported outcomes Exploratory objectives involve evaluating potential biomarkers predictive of treatment response and resistance as well as generating functional models to assess novel drug combinations targeting resistance mechanisms
Secondary Objectives Secondary objectives include evaluating the safety and tolerability of the combination therapy assessing objective response rate time to response duration of response overall survival and patient-reported outcomes Exploratory objectives involve evaluating potential biomarkers predictive of treatment response and resistance as well as generating functional models to assess novel drug combinations targeting resistance mechanisms
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