Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Botensilimab
  • Balstilimab
  • AGEN1423
  • Radiation

Treatment groups

24 Participants
are divided into 3 treatment groups

Locations

1
Weill Cornell Medicine/NewYork-Presbyterian Hospital10065, New YorkNew York, United States

Sponsors and collaborators

Weill Medical College of Cornell University

Lead sponsor

Agenus Inc.

Collaborator

Source ClinicalTrials.gov