Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Feb 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new combinations of immunotherapy treatments for patients with colorectal cancer that has spread to the liver. The main goal is to see if these treatments can help change the environment around the tumors in the liver and to find out if they are safe and effective before surgery to remove the tumors. Participants in the trial will be randomly assigned to receive one of three treatment combinations, which include different drugs and possibly radiation therapy. They will receive these treatments before and after their surgery and will be followed for up to two years to monitor their progress.

To be eligible for this trial, participants must have a specific type of colorectal cancer with liver metastases and must be planning to have surgery to remove those tumors. They should not have any serious medical conditions that could make the treatment risky, and they must agree to use effective birth control during the study if they can become pregnant. Participants will need to come in for drug infusions, and some may also receive radiation treatment. This trial is currently recruiting patients of all genders, aged 65 and older, who meet the necessary criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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
• • Participants must not have any contraindications to immune checkpoint inhibitors
• • Participants must not have active autoimmune disease that has required systemic treatment within 2 years prior to registration. Some exceptions are allowed