NCT06300463 Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
| NCT ID | NCT06300463 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Colorectal Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2024-03-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Manish Shah, M.D.
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06300463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06300463 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06300463 currently recruiting?
Yes, NCT06300463 is actively recruiting participants. Contact the research team at cdo4001@med.cornell.edu for enrollment information.
Where is the NCT06300463 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06300463 clinical trial?
NCT06300463 is sponsored by Weill Medical College of Cornell University. The principal investigator is Manish Shah, M.D. at Weill Medical College of Cornell University. The trial plans to enroll 24 participants.
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