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New treatment option for Colorectal Cancer Metastatic
Official title Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
ClinicalTrials.gov ID: NCT06300463
What this study is testing
What is Botensilimab?
Botensilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer metastatic.
Also referred to as AGEN1181.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Not eligible for surgery
- Any medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating...
- 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...
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.