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ReLOAD: Regorafenib and Lorigerlimab

RecruitingPhase 2InterventionalNCT07071961 ↗

This is a study to assess 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.

Sponsor
M.D. Anderson Cancer Center
Planned enrollment
16 participants
Start date
February 11, 2026
Primary completion
May 1, 2027 (est.)
Minimum age
18 Years
Interventions
Regorafenib (CT), Lorigerlimab

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]

This is a Phase 2 study to assess the effects of Regorafenib and Lorigerlimab on ctDNA in CRC patient with MRD after completing standard-of-care therapy.

Key Eligibility Criteria

  • Patients with confirmed stage II-IV colon or rectal cancer
  • Patients must:
    • have completed all planned adjuvant therapies
    • have no radiographic evidence of disease within 28 days of positive ctDNA assay
    • have confirmed ctDNA positive assay prior to starting study therapy

Treatment

Drug: Regorafenib, a kinase inhibitor

Drug: Lorigerlimab, a PD-1 and CTLA-4 inhibitor

ClinicalTrials.gov ID NCT07071961

Where this trial is offered

  • MD Anderson Cancer CenterHouston, Texas
    Recruiting

Status, sites, and study facts from ClinicalTrials.gov, last posted August 27, 2026 and refreshed here September 5, 2026.View the full record for NCT07071961.