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.

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NCT06300463

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Recruiting
PHASE2Ages 18+InterventionalTreatment
Weill Medical College of Cornell University
~24 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:BotensilimabBalstilimabAGEN1423Radiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm
Measured over At surgical resection
Colorectal Cancer Metastatic
Liver Metastases
Colorectal Cancer
1 sites across 1 states
New York1
  • Manish Shah, M.D. · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

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Eligibility criteria

Inclusion

Diagnosis of metastatic colorectal adenocarcinoma with liver metastases
Participant must be planning to undergo a surgical resection of their liver metastases.
Tumor is non-MSI-H/dMMR
Presence of measurable disease
Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes
Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study
Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment.

Exclusion

Not eligible for surgery
Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
Previous allogeneic tissue/organ transplant
Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents
Participants must not have any contraindications to immune checkpoint inhibitors
Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed
  • 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