Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646445
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Neoadjuvant Pembrolizumab with a Watch-and-wait Strategy for Patients with DMMRMSI-H Localized Colon Cancer GERCOR G-109 PRODIGE 84 PREMICES Phase II Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Pembrolizumab with a Watch-and-wait Strategy for Patients with Mismatch Repair-deficient or Microsatellite Instability-high dMMRMSI-H Localized Colon Cancer a Randomized GERCOR G-109 PRODIGE 84 PREMICES Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
PREMICES
Brief Summary:
The goal of this investigational study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach for localized dMMRMSI-H CRC patients The PREMICES trial is based on the hypothesis that non-operative management is efficient for dMMRMSI-H localized CRC patients treated with neoadjuvant pembrolizumab
Eligible patients will be randomized to receive pembrolizumab with a watch-and-wait approach experimental arm or standard strategy surgical resection adjuvant chemotherapy control arm in a 11 ratio
Eligible patients will be randomized to receive pembrolizumab with a watch-and-wait approach experimental arm or standard strategy surgical resection adjuvant chemotherapy control arm in a 11 ratio
Detailed Description:
dMMRMSI-H is a key biomarker for predicting the success of immune checkpoint inhibitors in colorectal cancer CRC Pembrolizumab has shown improved outcomes for patients with metastatic CRC becoming the new standard of care Neoadjuvant immunotherapy has demonstrated high rates of complete pathological responses in both metastatic and localized CRC with promising results in non-surgical approaches Studies support using a watch-and-wait strategy after immunotherapy potentially avoiding surgery These findings are reshaping treatment strategies for dMMRMSI-H CRC particularly regarding organ preservation and non-operative management
The PREMICES study evaluates the efficacy of neoadjuvant pembrolizumab combined with a watch-and-wait approach for treating localized dMMRMSI-H CRC patients It explores non-operative management as a potential strategy for achieving complete clinical response in dMMRMSI-H localized CRC without surgery
The PREMICES study evaluates the efficacy of neoadjuvant pembrolizumab combined with a watch-and-wait approach for treating localized dMMRMSI-H CRC patients It explores non-operative management as a potential strategy for achieving complete clinical response in dMMRMSI-H localized CRC without surgery
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