NCT07071961

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: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Regorafenib
• High Risk Patients

Interventions

Type	Name	Description
DRUG	Regorafenib (CT)	Given by po
DRUG	Lorigerlimab	Given by IV

Timeline

• Start date: 2026-02-11
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2025-07-18
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study