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
Histological confirmation of CRC
Post-R0 resection of stages II, III, or IV CRC and all planned adjuvant therapies have been completed.
No evidence of radiographic disease within 28 days (before or after) of a positive ctDNA assay
Evident MRD as defined by positive ctDNA assay. Participants may be identified for enrollment with any Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay for MRD. MRD status will be confirmed with the Signatera assay prior to initiation of therapy (unless the prior testing was also done with Signatera in which case this test would not require confirmation)
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.
Single group
Regorafenib (CT)
DrugGiven by po
Lorigerlimab
DrugGiven by IV
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
Click on the lead sponsor to view all of their trials.
