RECRUITING

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Quick Facts

Study Start:2024-03-26
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06300463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of metastatic colorectal adenocarcinoma with liver metastases
  2. * Participant must be planning to undergo a surgical resection of their liver metastases.
  3. * Tumor is non-MSI-H/dMMR
  4. * Presence of measurable disease
  5. * Participants must be willing to consent to additional molecular analyses of tumor samples removed during surgery for research purposes
  6. * 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
  7. * Participants may not receive chemotherapy, growth factor support, transfusions, or albumin administration within 14 days of start of study treatment.
  1. * Not eligible for surgery
  2. * 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.
  3. * Previous allogeneic tissue/organ transplant
  4. * Previously received PD-1, PD-L1, or CTLA-4 therapy including experimental immunologic agents
  5. * Participants must not have any contraindications to immune checkpoint inhibitors
  6. * Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed

Contacts and Locations

Study Contact

Casey Owens
CONTACT
646-962-8189
cdo4001@med.cornell.edu
Myriam Elizaire-Williams
CONTACT
mye4001@med.cornell.edu

Principal Investigator

Manish Shah, M.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Manish Shah, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-26
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-03-26
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Botensilimab
  • Balstilimab
  • Immunotherapy

Additional Relevant MeSH Terms

  • Colorectal Cancer Metastatic
  • Liver Metastases
  • Colorectal Cancer