This is a pilot study to assess the feasibility, safety, and efficacy of using a combination of a programmed cell death protein 1 (PD-1) inhibitor (balstilimab) and cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor (botensilimab) in the neoadjuvant setting in patients with colorectal cancer, prior to resection. This is a single-center, single-arm, open-label, pilot study in which patients will receive 2 doses of intravenous (IV) balstilimab (each dose approximately 2 weeks apart), and a single dose of botensilimab IV, within 8 weeks prior to resection in patients with colon cancer. Following surgical resection, participants will return to the clinic for 2 follow-up visits. Follow-up visit 1 will occur 1-3 weeks post-op (+/- 7 days), and follow-up visit 2 (+/- 7 days) will occur 4-6 weeks post-op.
This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they have on colorectal cancer. The two monoclonal antibodies are balstilimab, a programmed cell death protein 1 (PD-1) inhibitor, and botensilimab, a cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor. Participants will receive a dose of balstilimab and botensilimab, both given intravenously (IV), followed by a second dose of balstilimab approximately 2 weeks after the first dose. Both doses of balstilimab and the single dose of botensilimab will be given during an 8 weeks period before surgery.