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]

NCT07071961 | Suspended Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-1853NCI-2025-05156
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

High Risk Patients; Colorectal Cancer; Regorafenib

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

RELO in ctDNA+ mCRC

EXPERIMENTAL

receive regorafenib and lorigerlimab for up to 6 months

Drug: Regorafenib (CT); Drug: Lorigerlimab

Interventions

Regorafenib (CT) DRUG

Given by po

RELO in ctDNA+ mCRC

Lorigerlimab DRUG

Given by IV

RELO in ctDNA+ mCRC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Concurrent treatment with drug with which the interactions are considered clinically significant by investigator (as outlined in section 0). Major surgical procedure or significant traumatic injury within 21 days before start of study medication. Note: If participants received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
• Grade 2 or higher peripheral neuropathy per CTCAE v5.0.
• Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment except for participants who may be receiving low dose prednisone (specifically receiving ≤10 mg prednisone or equivalent within 7 days of treatment initiation).
• Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy for mCRC.
• Previous malignant disease (other than the target malignancy to be investigated in this trial) within 3 years prior to study treatment initiation.
• Receipt of any organ transplantation, including allogeneic stem cell transplantation (exception: transplants that do not require immunosuppression, such as hair transplant).
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. The study will allow replacement therapy with thyroxine, insulin or physiologic corticosteroid replacement therapy for autoimmune conditions that are well-controlled.
• Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCICTCAE v5.0), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma.
• Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \>II), myocarditis, or serious cardiac arrhythmia.
• Clinically relevant diseases (for example, inflammatory bowel disease) and / or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.
• Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2 per CTCAE v5.0.
• Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted). Patient should refrain to receive live-virus vaccines for 120 days following the last dose of lorigerlimab.
• Evidence of any serious bacterial, viral (active HIV, HCV or HBV), parasitic, or systemic fungal infections within the 30 days prior to the first dose of study drug.
• Subject is pregnant or breast feeding or planning to become pregnant while enrolled in the study, up to the final EOT visit.
• History of (non-infectious) pneumonitis that required steroids, ongoing pneumonitis, or history of interstitial lung disease.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bayer: collaborator
• MacroGenics: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Kanwal Raghav, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 18, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)