Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300463
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-29
Brief Title:
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None