Clinical trial · Interventional
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGEN1423 | Drug | — | UNRESOLVED |
| Balstilimab | Drug | — | UNRESOLVED |
| Botensilimab | Drug | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Botensilimab and Balstilimab
- description
- 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.
- interventionNames
- Drug: Botensilimab
- Drug: Balstilimab
- type
- EXPERIMENTAL
- label
- Botensilimab, Balstilimab, and AGEN1423
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available