Combination Immunotherapy in Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they have on colorectal cancer. The two monoclonal antibodies are balstilimab, a programmed cell death protein 1 (PD-1) inhibitor, and botensilimab, a cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor. Participants will receive a dose of balstilimab and botensilimab, both given intravenously (IV), followed by a second dose of balstilimab approximately 2 weeks after the first dose. Both doses of balstilimab and the single dose of botensilimab will be given during an 8 weeks period before surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Agenus Inc.

Criteria

Inclusion Criteria:

• 18 years of age or older

• Stage 1-3 adenocarcinoma of the colon with plans to have a surgical resection

• If capable of becoming pregnant, or getting someone else pregnant, must be willing to use highly effective contraception from Screening period through 90 days following the last dose of study drug

Exclusion Criteria:

• Metastatic cancer (cancer that has spread to other parts of the body)

• Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1

• Currently participating in another study and receiving a study drug

• History of severe allergic reactions to immunotherapies

• Pregnant or breastfeeding

• Active infection requiring treatment

• On immunosuppressive medications

• Active cardiovascular disease, such as stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure, or serious uncontrolled cardiac arrhythmia requiring medication that may prevent surgery