Combination immunotherapy for colorectal cancer treatment
Novel Exploratory Study to Test Combination of Botensilimab and Balstilimab Immunotherapy in Resectable Colorectal Cancer Patients
This study is testing a new combination of two drugs to see if they can safely help people with colorectal cancer before they have surgery to remove their tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | radiation, balstilimab, botensilimab |
| Locations | 3 sites (Brooklyn, New York and 2 other locations) |
| Trial ID | NCT05571293 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and efficacy of a combination of two investigational drugs, balstilimab and botensilimab, in patients with colorectal cancer before surgical tumor removal. Participants will receive either 2 or 4 doses of balstilimab and a single dose of botensilimab intravenously. The study aims to assess the feasibility of this neoadjuvant treatment approach and monitor any side effects. It includes three cohorts, with specific eligibility criteria for each, particularly focusing on patients with dMMR/MSI-High colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed adenocarcinoma of the colon or rectal cancer who are not planning to undergo neoadjuvant radiation.
Not a fit: Patients with metastatic cancer or those who have previously received immune checkpoint inhibitors targeting CTLA-4 or PD-1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with colorectal cancer by enhancing the immune response against tumors.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in colorectal cancer, suggesting potential for success in this pilot study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 Participants in Cohort C must be dMMR/MSI-High.
Where this trial is running
Brooklyn, New York and 2 other locations
- Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (Not_yet_recruiting)
- Weill Cornell Medicine/NewYork Presbyterian - Queens — Flushing, New York, United States (Not_yet_recruiting)
- Weill Cornell Medicine/NewYork-Presbyterian Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Manish Shah, M.D. — Weill Medical College of Cornell University
- Study coordinator: Casey Owens
- Email: cdo4001@med.cornell.edu
- Phone: 646-962-8189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.