To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have "positive" ctDNA tests for MRD (meaning there is evidence of MRD based on this test).
Participants must have histologically or cytologically confirmed microsatellite stable (MSS) colorectal adenocarcinoma.
Participants must have completed curative intent treatments of stages II, III, or IV colorectal cancer that must include ≥ 3 months of oxaliplatin containing chemotherapy.
No evidence of radiographic disease within 28 days (before or after) a positive ctDNA assay.
Participants must have minimal residual disease as defined by positive ctDNA assay by Signatera MRD assay.
Has other concomitant active, invasive malignancies that may interfere with ctDNA analysis (known clonal hematopoesis of unknown potential allowed).
Has serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range which are clinically significant in the investigator's judgment.
Has significant concomitant health conditions including but not limited to severe autoimmune or cardiovascular disorders that may interfere with participation in the study.
Active autoimmune diseases or history of autoimmune diseases that may worsen or relapse per treating providers' evaluation.
Single group
Tislelizumab
DrugGiven by IV
Fruquintinib
DrugGive by PO
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.
M.D. Anderson Cancer Center
Lead sponsor
BeiGene
Collaborator
Takeda Pharmaceutical Co. Limited
Collaborator
