Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353854
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-03-28
Brief Title:
Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSIdMMR Metastatic Colorectal Cancer CORESIM
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Federation Francophone de Cancerologie Digestive
Study Overview
Official Title:
National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
CORESIM
Brief Summary:
The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab anti-PD1 monoclonal antibody versus chemotherapy - targeted therapy in first-line treatment of dMMRMSI metastatic colorectal cancer mCRC However primary resistance to pembrolizumab was observed in approximately 20-30 of patients treated in the Keynote 177 study Therefore the identification of biomarkers predictive of resistance to immunotherapy for dMMRMSI mCRC is necessary to better select patients who benefit the most from immunotherapy and those for whom other therapeutic approaches should be favored
Detailed Description:
The primary endpoint is the identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI andor dMMR metastatic colorectal cancer
CORESIM is a retrospective and prospective multicenter national French cohort National recruitment will be carried out in all French centers including the FFCD AGEO GERCOR and UNICANCER representing more than 150 centers and most French sites public and private hospitals
In France pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021 then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study ie on February 2024 patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected The theoretical duration of inclusion is set at 2 years All patients will be followed up for 3 years
CORESIM is a retrospective and prospective multicenter national French cohort National recruitment will be carried out in all French centers including the FFCD AGEO GERCOR and UNICANCER representing more than 150 centers and most French sites public and private hospitals
In France pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021 then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study ie on February 2024 patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected The theoretical duration of inclusion is set at 2 years All patients will be followed up for 3 years
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