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]

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer; Regorafenib; High Risk Patients
• Interventions: Drug: Regorafenib (CT); Drug: Lorigerlimab

• Registration Number: NCT07071961
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2026-01-01
• Primary Completion: 2027-05-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RELO in ctDNA+ mCRC	Regorafenib (CT)	receive regorafenib and lorigerlimab for up to 6 months
RELO in ctDNA+ mCRC	Lorigerlimab	receive regorafenib and lorigerlimab for up to 6 months

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States