Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-27 @ 9:23 PM
Study NCT ID:
NCT07071961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial]
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial]
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
None
Brief Summary:
To learn about the effects of the drugs regorafenib and lorigerlimab on circulating tumor DNA (ctDNA) in patients with CRC and who have radiographic occult minimal residual disease (MRD) after completing standard-of-care therapy
Detailed Description:
Primary Objectives
• To determine the 6-month circulating tumor (ctDNA) clearance rate following 6 months of therapy with RELO regimen in patients with colorectal cancer (CRC) who present with radiographic occult molecular residual disease (MRD) after completing definitive standard-of-care (SOC) therapy.
Secondary Objectives
* To determine the 3-month ctDNA clearance rate following RELO treatment.
* To determine disease-free survival (DFS) following 6 months of RELO treatment.
* To determine overall survival (OS) following 6 months of RELO treatment.
* To determine the safety and tolerability of RELO.
• To determine the 6-month circulating tumor (ctDNA) clearance rate following 6 months of therapy with RELO regimen in patients with colorectal cancer (CRC) who present with radiographic occult molecular residual disease (MRD) after completing definitive standard-of-care (SOC) therapy.
Secondary Objectives
* To determine the 3-month ctDNA clearance rate following RELO treatment.
* To determine disease-free survival (DFS) following 6 months of RELO treatment.
* To determine overall survival (OS) following 6 months of RELO treatment.
* To determine the safety and tolerability of RELO.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-05156 | OTHER | NCI-CTRP Clinical Registry | View |