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RECRUITING
NCT06300463
PHASE2

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-03-26

Completion Date

2027-12

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DRUG

Botensilimab

75 mg IV Q6W

DRUG

Balstilimab

450 mg IV Q3W

DRUG

AGEN1423

30 mg/kg IV Q3W

RADIATION

Radiation

8Gy x 3 between Day 0 - 18; Allowed techniques for radiation are 3D conformal, intensity modulated radiotherapy (IMRT), or SBRT

Locations (1)

Weill Cornell Medicine/NewYork-Presbyterian Hospital

New York, New York, United States