Immunotherapy Combinations for Colorectal Cancer Liver Metastases
This study is for people with colorectal cancer that has spread to their liver and who are planning surgery to remove these liver metastases. It aims to see how different combinations of immunotherapies affect the tumor and if they are safe and effective. You would receive combinations of Botensilimab, Balstilimab, and/or AGEN1423, with some participants also receiving radiation. The main goal is to see if these treatments change the tumor environment, specifically by looking at certain immune cells (CD8:Treg ratio) in the tumor tissue removed during surgery. You must have non-MSI-H/dMMR colorectal cancer (meaning your tumor does not have a specific genetic marker) and measurable disease to join. The study is currently unclear about its recruitment status.
- Study design
- This is a single-center, randomized, open-label study with three treatment arms, planning to enroll 24 participants. It is a Phase II screening study.
- What's involved
- You would have four treatment visits for immunotherapy infusions, two before surgery and two after. Surgery will be scheduled between Day 28-42.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the last dose of immunotherapy, you will have follow-up visits approximately 3 weeks and 3 months later.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Manish Shah, M.D. · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment armAt surgical resection
Preliminary immunological response to treatment will be assessed by comparison of the CD8:Treg ratios in tumor tissue obtained during standard of care surgical resection between treatment arms. CD8:Treg ratio will be assessed by flow cytometry