Stopped: Study is temporarily paused to review safety data.
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.
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Cohort A and B: Pathological overall response (pOR) rate determined by analysis of tissue resected during surgery reported by cohort
Timeframe: 1-6 weeks following the second dose of balstilimab
Cohort A: Number of participants who experience potentially treatment-related SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 days following the last treatment with balstilimab or botensilimab
Timeframe: 90 days post-the last dose of study drug
Cohort A: Number of participants who experience treatment-related complications leading to delays of 12 weeks or more in surgery after treatment initiation (Day 0)
Timeframe: Approximately Day 90
Cohort C: Composite rate of clinical complete response or major pathological response at 6 months
Timeframe: 6 months