Testing immunotherapy combinations for colorectal cancer that has spread to the liver
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
PHASE2 · Weill Medical College of Cornell University · NCT06300463
This study is testing different combinations of immunotherapy treatments for people with colorectal cancer that has spread to the liver to see if they can improve treatment results before surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University (other) |
| Drugs / interventions | chemotherapy, Botensilimab, balstilimab, immunotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06300463 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of different combinations of immunotherapy in patients with colorectal cancer that has metastasized to the liver and are scheduled for surgery. Participants will be randomly assigned to receive either Botensilimab and Balstilimab, a combination of these two drugs with AGEN1423, or the same two drugs with radiation. The study will assess changes in the tumor microenvironment and monitor participants for up to two years after treatment. The goal is to identify promising immunotherapy combinations that could improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with metastatic colorectal adenocarcinoma with liver metastases who are planning to undergo surgical resection.
Not a fit: Patients who are not eligible for surgery or have uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with colorectal cancer liver metastases.
How similar studies have performed: Other studies have shown promise with immunotherapy approaches in similar contexts, but this specific combination is being tested for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Weill Cornell Medicine/NewYork-Presbyterian Hospital — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Manish Shah, M.D. — Weill Medical College of Cornell University
- Study coordinator: Casey Owens
- Email: cdo4001@med.cornell.edu
- Phone: 646-962-6046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer Metastatic, Liver Metastases, Colorectal Cancer, Botensilimab, Balstilimab, Immunotherapy