Actively Recruiting
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Led by Weill Medical College of Cornell University · Updated on 2026-04-01
24
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of metastatic colorectal adenocarcinoma with liver metastases
- Planning to undergo surgical resection of liver metastases
- Tumor is non-MSI-H/dMMR
- Presence of measurable disease
- Willing to consent to additional molecular analyses of tumor samples removed during surgery
- Women of childbearing potential or anyone with a uterus must not be pregnant or breastfeeding and agree to use highly effective contraception during the study
- No chemotherapy, growth factor support, transfusions, or albumin administration within 14 days before starting study treatment
You will not qualify if you...
- Not eligible for surgery
- Any uncontrolled medical condition such as infection, diabetes, or heart disease making the study hazardous in the opinion of the treating physician
- Previous allogeneic tissue or organ transplant
- Prior treatment with PD-1, PD-L1, or CTLA-4 therapies including experimental immunologic agents
- Contraindications to immune checkpoint inhibitors
- Active autoimmune disease requiring systemic treatment within 2 years prior to registration, with some exceptions allowed
AI-Screening
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Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
Research Team
C
Casey Owens
CONTACT
M
Myriam Elizaire-Williams
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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