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Combination Immunotherapy in Colorectal Cancer
Sponsor: Weill Medical College of Cornell University
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.
Official title: Novel Exploratory Study to Test Combination of Botensilimab and Balstilimab Immunotherapy in Resectable Colorectal Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2023-03-17
Completion Date
2024-11-14
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Botensilimab
Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description.
Balstilimab
Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description.
Locations (3)
Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Weill Cornell Medicine/NewYork Presbyterian - Queens
Flushing, New York, United States
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, United States