Ignite Creation Date:
2024-05-06 @ 4:31 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05019534
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2021-08-05
Brief Title:
Tolerability and Safety of Vemurafenib Cetuximab Combined With Camrelizumab for BRAF V600E-mutated MSS Metastatic Colorectal Cancer
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
A Phase I Study on Tolerance and Safety of Vemurafenib Film-coated Tablets Cetuximab Solution for Infusion and Camrelizumab ProtocolVCC in the After Line Therapy of BRAF V600E MutationMSS Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
BRAF mutation exists in about 10-12 of colorectal cancer among which BRAF V600E mutation is the most common type which is an important biomarker for predicting the prognosis and precise treatment efficacy of metastatic colorectal cancer mCRC The prognosis of metastatic colorectal cancer with BRAF V600E mutation is very poor with OS of about 6-9 months Previous studies have shown that single anti-BRAF inhibitor are ineffective while multi-target inhibitions of Ras-Raf -MEK pathway is a possible effective strategy for BRAF V600E-mutant mCRC Currently the proven effective regimens include the VIC regimen Vemurafenib cetuximab Irinotecan and BEACON regimen Encorafenib cetuximab - Binimetinib from the SWOGS1406 study Furthermore BRAF inhibitor MEK inhibitor combined with PD-1 monoclonal antibody has been shown to be an effective strategy in BRAF V600E-mutant malignant melanoma which promote the study of the regimens for the treatment of BRAF V600E-mutant mCRC Increasing basic and clinical studies have shown that cetuximab has ADCC effect induces immunogenic cell death promotes immune cell infiltration and other immunomodulatory effects and has a synergistic effect with PD-1 monoclonal antibody in colorectal cancer Based on those theories we conducted the phase I study to explore the safety and preliminary efficacy of the regimen of Vemurafenib BRAFi plus cetuximab EGFRi combined with PD-1 monoclonal antibody in BRAF V600E-mutant MSS type mCRC
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