Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346197
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-08
Brief Title:
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSIdMMR Esogastric Adenocarcinomas
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
A Multicenter Randomised Comparative Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSIdMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors Botensilimab Balstilimab Versus the Standard of Care FOLFOXXELOX Nivolumab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
CIME
Brief Summary:
CIME is a multicenter randomised comparative open-label phase III study aiming to compare the survival of patients suffering from MSI-HdMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy experimental arm versus standard current treatment FOLFOXXELOX nivolumab standard arm
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