National Cancer Institute (NCI)
This phase II trial tests the effect of the botensilimab in combination with balstilimab in treating patients with stage II/III colorectal adenocarcinoma with detectable circulating tumor (ct) deoxyribonucleic acid (DNA) in the blood. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab may be an effective combination to remove any remaining microscopic cancer cells in the bloodstream in patients with stage II/III colorectal adenocarcinoma. In addition, clearing the ctDNA from the blood may serve as an early indicator of treatment response.
PRIMARY OBJECTIVE: I. To determine the 6-month circulating tumor DNA (ctDNA) clearance rate following 6 months of therapy with botensilimab (AGEN1181) and balstilimab (AGEN2034) 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: I. To determine the 3-month ctDNA clearance rate following botensilimab (AGEN1181) and balstilimab (AGEN2034) treatment. II. To determine recurrence-free survival (RFS) at 1-year following 6 months of botensilimab (AG…
Inclusion Criteria: * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of botensilimab (AGEN1181) in combination with balstilimab (AGEN2034) in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 (or Karnofsky ≥ 60%) * Absolute neutrophil count ≥ 1,000/mcL * Platelets ≥ 100,000/mcL * Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN) * Patients with documented Gilbert's syndrome may be included if total bilirubin is ≤ 3 x ULN * Aspartate aminotra…
Given IV
Undergo tumor tissue biopsy
Undergo urine and blood sample collection
Given IV
Undergo imaging
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