Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT07223567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2025-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
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:
None
Brief Summary:
This is a prospective single-center, single-arm, open-label, phase II study evaluating the safety, activity, and efficacy of regorafenib in combination with lorigerlimab for the treatment of patients with regrowing or locally recurrent pMMR/MSS localized rectal cancer following TNT.
Detailed Description:
Primary Objective:
To assess the major pathological response (MPR) rate following regorafenib plus lorigerlimab and surgical resection in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy. MPR is defined as residual (viable) invasive cancer cells of 0 - 49% within the resected specimen at the time of surgical resection.
Secondary Objectives:
To estimate overall response rate (ORR) based on RECIST 1.1 following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate immune-related objective response rate (irORR) based on irRECIST following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To describe the R0 resection rate following neoadjuvant regorafenib plus lorigerlimab and surgical resection in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To summarize pathological response (% tumor viability, ypTNM) in surgically resected specimens following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate time to surgical resection following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate permanent ostomy rate following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate clinical complete response rate following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
To assess the major pathological response (MPR) rate following regorafenib plus lorigerlimab and surgical resection in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy. MPR is defined as residual (viable) invasive cancer cells of 0 - 49% within the resected specimen at the time of surgical resection.
Secondary Objectives:
To estimate overall response rate (ORR) based on RECIST 1.1 following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate immune-related objective response rate (irORR) based on irRECIST following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To describe the R0 resection rate following neoadjuvant regorafenib plus lorigerlimab and surgical resection in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To summarize pathological response (% tumor viability, ypTNM) in surgically resected specimens following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate time to surgical resection following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate permanent ostomy rate following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate clinical complete response rate following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-08120 | OTHER | NCI-CTRP Clinical Trials Registry | View |