drugset / Trial / NCT06300463

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

NCT06300463

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-03-26
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AGEN1423 Unknown 30 mg/kg Intravenous
Subject Balstilimab Monoclonal antibody 450 mg Intravenous
Subject Botensilimab Monoclonal antibody 75 mg Intravenous