City of Hope Medical Center
This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.
PRIMARY OBJECTIVE: I. To estimate the two-year disease-free survival (DFS) rate when treating advanced mismatch repair proficient (pMMR)/microsatellite stable (MSS) colorectal cancer with botensilimab (BOT)/balstilimab (BAL) followed by surgery. SECONDARY OBJECTIVES: I. To determine the major pathologic response rate for patients with advanced mismatch repair proficient or microsatellite stable (pMMR or MSS) colorectal cancer treated with botensilimab (BOT) + balstilimab (BAL) followed by surgery. II. To evaluate the safety of treating advanced pMMR/MSS colorectal cancer with BOT/BAL follo…
Inclusion Criteria: * Documented informed consent of the participant and Legally Authorized Representative (when applicable) * Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines * Agreement to allow the use of tissue from past and future surgery and standard of care biopsies * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed or cytologically confirmed colorectal adenocarcinoma. Patients with high grade dysplasia on histology plus unequivocal endoscopic or radiological evidence of invas…
Given IV
Undergo blood sample collection
Given IV
Undergo CT scan
Undergo MRI