Botensilimab + Balstilimab for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests the effect of the botensilimab in combination with balstilimab in treating patients with stage II/III colorectal adenocarcinoma with detectable circulating tumor (ct) deoxyribonucleic acid (DNA) in the blood. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab may be an effective combination to remove any remaining microscopic cancer cells in the bloodstream in patients with stage II/III colorectal adenocarcinoma. In addition, clearing the ctDNA from the blood may serve as an early indicator of treatment response.
Who Is on the Research Team?
Kanwal P Raghav
Principal Investigator
University of Texas MD Anderson Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults (18+) with stage II or III colorectal adenocarcinoma who have cancer DNA detected in their blood after standard treatment. Participants need to be in reasonably good health, with adequate blood counts and organ function.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Balstilimab
- Botensilimab
Trial Overview
The study is testing a combination of two immunotherapy drugs, botensilimab and balstilimab, given after standard treatment to see if they can help the immune system clear remaining cancer cells from the bloodstream. The trial includes regular scans and blood tests.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive balstilimab IV over 30 minutes on days 1 and 22 of cycles 1-4 and botensilimab IV over 30 minutes on days 1 of cycles 1 and 2. Treatment repeats every 42 days for up to 4 cycles (6 months) in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection and imaging throughout the study. Additionally, patients may undergo optional tumor tissue biopsy on study.
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
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