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Trial Title:
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
NCT ID:
NCT06300463
Condition:
Colorectal Cancer Metastatic
Liver Metastases
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Conditions: Keywords:
Botensilimab
Balstilimab
Immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Botensilimab
Description:
75 mg IV Q6W
Arm group label:
Botensilimab and Balstilimab
Arm group label:
Botensilimab, Balstilimab, and AGEN1423
Arm group label:
Botensilimab, Balstilimab, and Radiation
Other name:
AGEN1181
Intervention type:
Drug
Intervention name:
Balstilimab
Description:
450 mg IV Q3W
Arm group label:
Botensilimab and Balstilimab
Arm group label:
Botensilimab, Balstilimab, and AGEN1423
Arm group label:
Botensilimab, Balstilimab, and Radiation
Other name:
AGEN2034
Intervention type:
Drug
Intervention name:
AGEN1423
Description:
30 mg/kg IV Q3W
Arm group label:
Botensilimab, Balstilimab, and AGEN1423
Intervention type:
Radiation
Intervention name:
Radiation
Description:
8Gy x 3 between Day 0 - 18; Allowed techniques for radiation are 3D conformal, intensity
modulated radiotherapy (IMRT), or SBRT
Arm group label:
Botensilimab, Balstilimab, and Radiation
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.
Detailed description:
This is a single-center, 3-arm, randomized, open-label, phase II, screening study to
assess the initial immunological changes in the tumor microenvironment in response to
treatment with combination immunotherapy (Botensilimab/ Balstilimab), with or without
radiation and/or additional TGFβ-CD73 trap, in patients with colorectal cancer liver
metastases.
Participants who meet eligibility criteria will be randomized to receive one of 3
investigational treatment: botensilimab + balstilimab (Arm 1); botensilimab + balstilimab
+ AGEN1423 (Arm 2); or botensilimab + balstilimab + radiation (Arm 3). The study arms are
not directly or formally compared with each other. It is established that the tumor
infiltrating lymphocytes have been predictive of patient survival following resection of
colorectal cancer liver metastases. Immunotherapy combinations with an increase in the
ratio of CD8+ T cells: Tregs will be considered for further investigation.
All participants will have a total of four treatment visits to receive immunotherapy
infusions. Two visits will occur prior to surgery, each approximately 3 weeks apart.
Surgery will be scheduled between day 28-42. After surgery, you will return for two more
treatment visits. After the last dose of immunotherapy, participants will come to the
clinic approximately 3 weeks and 3 months later for follow-up visits. Participants will
be followed remotely for up to two years.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Weill Cornell Medicine/NewYork-Presbyterian Hospital
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Casey Owens
Phone:
646-962-8189
Email:
cdo4001@med.cornell.edu
Contact backup:
Last name:
Myriam Elizaire-Williams
Email:
mye4001@med.cornell.edu
Start date:
March 26, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Collaborator:
Agency:
Agenus Inc.
Agency class:
Industry
Source:
Weill Medical College of Cornell University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300463
