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COMPLETED
NCT05571293
PHASE2

Combination Immunotherapy in Colorectal Cancer

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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

Interventions

DRUG

Botensilimab

Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description.

DRUG

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