Testing immunotherapy combinations for colorectal cancer that has spread to the liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of different combinations of immunotherapy in patients with colorectal cancer that has metastasized to the liver and are scheduled for surgery. Participants will be randomly assigned to receive either Botensilimab and Balstilimab, a combination of these two drugs with AGEN1423, or the same two drugs with radiation. The study will assess changes in the tumor microenvironment and monitor participants for up to two years after treatment. The goal is to identify promising immunotherapy combinations that could improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Weill Cornell Medicine/NewYork-Presbyterian Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Manish Shah, M.D. — Weill Medical College of Cornell University
• Study coordinator: Casey Owens
• Email: cdo4001@med.cornell.edu
• Phone: 646-962-6046

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining radiation therapy and PD-1 antibody for liver metastases from colorectal cancer

  This study is testing if combining a special type of radiation therapy with a new immune treatment can help people with liver cancer from colorectal cancer feel better and live longer.

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• Evaluating a new immuno-adjuvant for colorectal liver metastases after ablation treatments

  This study is testing a new treatment called IP-001 to see if it can boost the immune response and help people with colorectal liver metastases feel better after they have undergone ablation therapies.

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• ctDNA blood tests to guide treatment in colorectal cancer with liver metastases

  A study using blood tests that look for tumor DNA to help decide which patients with colorectal cancer that has spread to the liver need more treatment after surgery.

  Recruiting at 2 sites University Hospital, Montpellier · Montpellier and 1 other locations · NCT06287723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.