At a glance
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Novel Exploratory Study to Test Combination of Botensilimab and Balstilimab Immunotherapy in Resectable Colorectal Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Botensilimab and Balstilimab for Colorectal Neoplasms. Active but no longer recruiting, targeting 26 participants across 3 sites.
Detailed Summary
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. This study has 3 cohorts. Participants in Cohort A will receive a total of 2 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort B and C will receive a total of 4 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort C must have dMMR/MSI-High colorectal cancer.
Study Details
Timeline
Interventions
Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description.
Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description.