NCT05571293CompletedPhase 2
Combination Immunotherapy in Colorectal Cancer
Novel Exploratory Study to Test Combination of Botensilimab and Balstilimab Immunotherapy in Resectable Colorectal Cancer Patients
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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. This study has 3 cohorts. Participants in Cohort A will receive a total of 2 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort B and C will receive a total of 4 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort C must have dMMR/MSI-High colorectal cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 4 Oct 2022
- Start date
- 17 Mar 2023
- Primary completion date
- 14 Nov 2024
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Colorectal cancer
- NCT number
- NCT05571293
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 26
- From 17 Mar 2023 to the primary completion date, 14 Nov 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1
- Currently participating in another study and receiving a study drug
- On immunosuppressive medications
Other illness
- Metastatic cancer (cancer that has spread to other parts of the body)
- History of severe allergic reactions to immunotherapies
- Active infection requiring treatment
- 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
- Participants in Cohort C must be dMMR/MSI-High.
Other
- Pregnant or breastfeeding
Who the study is looking for
- 18 years of age or older
- Histologically, cytologically, or clinically confirmed adenocarcinoma of the colon or rectal cancer as long as there is no plans for neoadjuvant radiation for the patients with rectal cancer. Note: patients can enroll in cohort B while awaiting mismatch repair testing results. If noted to be dMMR/MSI-High, they would be still considered evaluable and moved to cohort C.
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Weill Cornell Medicine/NewYork Presbyterian - Queens Coordinator of this site? Confirm its status | Flushing | United States | Unknown status |
| Weill Cornell Medicine/NewYork-Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.