Study on Anti-Cancer Drugs Botensilimab and Balstilimab After Standard Treatment for Colorectal Cancer

Program Overview

This study is exploring whether the combination of two immunotherapy drugs, botensilimab and balstilimab, can help the immune system attack and remove any remaining cancer cells in the blood of patients with stage II/III colorectal cancer. The trial aims to see if this treatment can clear circulating tumor DNA (ctDNA) from the blood, which may indicate a positive response to the treatment.

Description

The main goal of this study is to find out how effective the combination of botensilimab and balstilimab is in clearing circulating tumor DNA (ctDNA) from the blood after six months of treatment in patients with colorectal cancer who have no visible signs of cancer but still have molecular residual disease (MRD) after completing standard treatment.

Secondary goals include:

• Checking the ctDNA clearance rate after three months of treatment.
• Evaluating how long patients remain free from cancer recurrence one year after treatment.
• Assessing overall survival one year after treatment.
• Determining the safety and tolerability of the drug combination.
• Investigating if certain genetic markers can predict the treatment's effectiveness.

Patients will receive balstilimab through an IV on specific days of each treatment cycle and botensilimab on other days. The treatment cycles repeat every 42 days for up to four cycles (six months), unless the cancer progresses or side effects become unacceptable. Patients will also have regular blood and urine tests, imaging scans, and may have optional tumor biopsies.

After completing the treatment, patients will be monitored for up to three years with regular follow-up visits to check for cancer recurrence or other health changes.

Eligibility Criteria

Locations