Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3

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.

NCT Number	NCT07595874
Lead Sponsor	City of Hope Medical Center Collaborators: National Cancer Institute (NCI)
Conditions	Advanced Colon Adenocarcinoma, Advanced Colorectal Adenocarcinoma, Advanced Rectal Adenocarcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage IIC Rectal Cancer AJCC v8, Stage IIIA Colon Cancer AJCC v8 +5 more
Enrollment	100 participants
Start Date	2026-12-27
Primary Completion	2027-05-27 (estimated)
Study Completion	2027-05-27 (estimated)
Updated on ClinicalTrials.gov	2026-07-01