Phase
Condition
N/ATreatment
Botensilimab
Balstilimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years of age or older
Histologically, cytologically, or clinically confirmed adenocarcinoma of the colonor rectal cancer as long as there is no plans for neoadjuvant radiation for thepatients with rectal cancer. Note: patients can enroll in cohort B while awaitingmismatch repair testing results. If noted to be dMMR/MSI-High, they would be stillconsidered evaluable and moved to cohort C.
If capable of becoming pregnant, or getting someone else pregnant, must be willingto use highly effective contraception from Screening period through 90 daysfollowing the last dose of study drug
Exclusion
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 6months of enrollment, unstable angina, congestive heart failure, or seriousuncontrolled cardiac arrhythmia requiring medication that may prevent surgery
Participants in Cohort C must be dMMR/MSI-High.
Study Design
Study Description
Connect with a study center
Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York 11215
United StatesSite Not Available
Weill Cornell Medicine/NewYork Presbyterian - Queens
Flushing, New York 11355
United StatesSite Not Available
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York 10021
United StatesSite Not Available

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