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Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Clinical Trial Details

This clinical trial is for men and women who have been diagnosed with colorectal cancer that has spread to their liver and are eligible for standard of care surgery to remove tumors in their liver.
   
The purpose of this study is to evaluate the safety and effectiveness of investigational treatments that enhance a participant’s immune system (immunotherapy) given before and after surgery to remove the tumor in their liver. There are three treatment arms in this research study. Each treatment arm examines a new way to activate a participant’s immune system against their cancer. Investigators hope to learn whether giving different combinations of immunotherapy shortly before and after surgery to remove a participant’s cancer will improve their own immune system’s response to the cancer.
   
Participants will be randomly assigned to one of these three treatments. The treatments include: 
   • A combination of two investigational drugs, botensilimab and balstilimab 
   • A combination of three investigational drugs, AGEN-1423, botensilimab and balstilimab 
   • A combination of two investigational drugs, botensilimab and balstilimab, with radiation 
   
Botensilimab, balstilimab, and AGEN-1423 are experimental which means that they are being tested and are not approved by the United States Food and Drug Administration (FDA). Combining radiation with any of these experimental drugs is also considered experimental.
   
Participants will come to the study clinic four times for intravenous infusions of two or three investigational drugs, depending on which study arm they are assigned to. Two treatment visits will occur before a participant’s scheduled surgery and two will occur after their surgery. If a participant is assigned to receive radiation, they will also receive 3 doses of radiation before surgery.
   
Participants will be followed by the research team for up to 2 years. Participants will be asked to come into the study clinic for in-person visits and procedures for approximately the first 6 months, but after about 90 days following their surgery, they will not need to come to the study clinic for any study-specific procedures.

Key Eligibility: 
  1. Adults with histologically confirmed diagnosis of metastatic colorectal adenocarcinoma who are planning to undergo a resection of their hepatic metastases.
  2. Must be eligible for surgery.
  3. Must not have any contraindications to immune checkpoint inhibitors 

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Marie Stefania
646-962-3541
mgs4003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2306026214

ClinicalTrials.gov:

NCT06300463

Sponsor:

IIT CRC Immunotherapy Platform

Status

Open to Enrollment

Age Group

Adult

Sponsor