M.D. Anderson Cancer Center
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
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 tolerabili…
Eligibility Criteria * 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 t…
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