Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Botensilimab
- Balstilimab
- AGEN1423
- Radiation
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Agenus Inc.
Collaborator
Source ClinicalTrials.gov