Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes

• Women of childbearing potential (WOCBP), or anyone with a uterus, must not be pregnant or breastfeeding. All participants of childbearing potential must agree to use highly effective contraception during this study

• Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment.

Locations
United States
New York
Weill Cornell Medicine/NewYork-Presbyterian Hospital
RECRUITING
New York
Contact Information
Primary
Casey Owens
cdo4001@med.cornell.edu
646-962-6046
Backup
Myriam Elizaire-Williams
mye4001@med.cornell.edu
Time Frame
Start Date: 2024-03-26
Estimated Completion Date: 2027-03
Participants
Target number of participants: 24
Treatments
Experimental: Botensilimab and Balstilimab
Two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.
Experimental: Botensilimab, Balstilimab, and AGEN1423
Two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. On the same day as each balstilimab infusion, participants will also receive AGEN1423 infusions, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab + AGEN1423 infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.
Experimental: Botensilimab, Balstilimab, and Radiation
Participants will receive 3 doses of radiation prior to surgery. Additionally, two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: Agenus Inc.

This content was sourced from clinicaltrials.gov