Phase II Study of Botensilimab and Balstilimab Before Surgery for Advanced Resectable Colorectal Cancer

What this Trial Is About

Researchers are evaluating the use of botensilimab and balstilimab as neoadjuvant immunotherapy treatments for adults with advanced resectable colorectal cancer that may have spread locally or to nearby lymph nodes but can still be surgically removed. This phase II trial focuses on patients with mismatch repair proficient or microsatellite stable tumors. The study aims to estimate disease-free survival rates and assess tumor responses and safety when these treatments are given before surgery. Participants receive botensilimab intravenously on day 1 and balstilimab intravenously on days 1, 15, 29, and 43, provided there is no disease progression or unacceptable side effects. Surgery to remove the tumor is performed 5 to 16 weeks after starting treatment. Throughout the study, participants undergo CT or MRI scans and blood sample collections to monitor their condition. After completing treatment and surgery, participants are followed up at 2 weeks, 4 weeks, then every 3 months for 2 years, followed by every 6 months for 1 year. Researchers will evaluate outcomes including disease-free survival at 2 and 3 years, pathologic response rates, recurrence-free survival, safety, quality of life, and time to surgery. Exploratory studies include analyzing tumor microenvironment changes and circulating tumor DNA levels to understand treatment effects and disease recurrence.

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