RecruitingPhase 2NCT06300463

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Sponsor

Weill Medical College of Cornell University

Enrollment

24 participants

Start Date

Mar 26, 2024

Study Type

INTERVENTIONAL

Conditions

Liver Metastases Colorectal Cancer Metastatic

Summary

The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are: * whether these combinations of immunotherapy change the tumor microenvironment in the liver * whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastases Participants will be randomly assigned to one of the following: * Botensilimab and balstilimab * Botensilimab, balstilimab, and AGEN1423 * Botensilimab, balstilimab, and radiation Participants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This platform study tests different immunotherapy drug combinations in people with colorectal cancer that has spread to the liver and who are scheduled to have surgery to remove those liver tumors. The goal is to find which immune-activating drug combinations work best before surgery. **You may be eligible if...** - You have been diagnosed with colorectal cancer that has spread to the liver - You are planning to have surgery to remove the liver tumors - Your tumor does not have the MSI-H/dMMR marker (a specific genetic feature) - Your cancer can be measured on imaging - You agree to allow extra tumor tissue samples to be used for research **You may NOT be eligible if...** - You are not a candidate for surgery - You are pregnant or breastfeeding - You received chemotherapy, growth factors, transfusions, or albumin within 14 days before starting treatment - Your tumor has the MSI-H/dMMR marker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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