Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567782
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin CAPEOX Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient MMRpMicrosatellite Stable MSS Colon Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open Label Randomized Study of Neoadjuvant Dostarlimab Plus CAPEOX Versus CAPEOX in Participants With Previously Untreated T4N0 or Stage III MMRp MSS Colon Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AZUR-4
Brief Summary:
The main goal of this study is to test a new treatment approach for colon cancer The treatment involves dostarlimab along with a specific type of chemotherapy called CAPEOX short for capecitabine oxaliplatin to check if using these two together works better than using just CAPEOX by itself This treatment is given before any surgery takes place a method referred to as neoadjuvant therapy The aim is to see if this new approach can show early signs of effectiveness in treating participants with a specific type of colon cancer known as mismatch repair proficient microsatellite stable MMRpMSS where the cells have normal repair systems and stable DNA sequences This study will also look at specific signs in the blood and tumor to see if they can help predict how well the treatment is working This could help better understand how dostarlimab contributes to the response of the disease to treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None