Study on Botensilimab and Balstilimab Before Surgery for Advanced Colorectal Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT07595874
This clinical trial is testing whether giving two immunotherapy drugs, botensilimab and balstilimab, before surgery can help treat advanced colorectal cancer that can be surgically removed. The study aims to see if this approach can shrink tumors and improve outcomes for patients.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of using two immunotherapy drugs, botensilimab and balstilimab, before surgery to treat advanced colorectal cancer that can be removed by surgery. These drugs may help the immune system attack cancer cells and prevent them from growing and spreading. By administering these drugs before surgery, researchers hope to reduce the size of the tumor and improve treatment success.
Description
The main goal of this study is to find out if using botensilimab and balstilimab before surgery can help patients with advanced colorectal cancer live longer without the disease returning. Researchers will also look at how well the treatment works in shrinking the tumor and how safe it is for patients.
Participants will receive botensilimab and balstilimab through an IV on specific days before undergoing surgery to remove the cancer. Throughout the study, patients will have CT or MRI scans and blood tests to monitor their progress.
After completing the treatment, patients will have follow-up visits at 2 weeks, 4 weeks, and then every 3 months for 2 years, followed by every 6 months for an additional year.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of colorectal cancer that can be surgically removed.
- Must be in good overall health with an ECOG performance status of 0 to 2.
- Must have specific types of colorectal cancer that are suitable for this treatment.
- Must have adequate blood cell counts and organ function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified time after treatment.
- Men must agree to use effective birth control or abstain from sexual activity during the study and for a specified time after treatment.
Exclusion Criteria
- Have received any prior treatment for colorectal cancer, including chemotherapy, surgery, or radiation.
- Have a condition requiring high doses of steroids or other immunosuppressive medications.
- Have had an organ transplant.
- Have another active cancer that could interfere with the study.
- Have an uncontrolled illness or infection, including HIV or hepatitis.
- Women who are pregnant or breastfeeding.
- Have a history of severe allergic reactions to the study drugs.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have any condition that might interfere with the study or the patient's ability to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| City of Hope Corona | 92882 | Corona | California |
| City of Hope Medical Center | 91010 | Duarte | California |
| City of Hope Seacliff | 92648 | Huntington Beach | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| City of Hope at Long Beach Elm | 90813 | Long Beach | California |
| City of Hope South Pasadena | 91030 | South Pasadena | California |
| City of Hope Upland | 91786 | Upland | California |
| City of Hope Atlanta Cancer Center | 30265 | Newnan | Georgia |
| City of Hope at Illinois Chicago Downtown | 60611 | Chicago | Illinois |
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