Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater or in patients age 18 or greater considered poor candidates for surgery or unwilling to undergo surgery.
Inclusion Criteria for Cohort A and B: * Age ≥70 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 * Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer. * Must not have received any prior systemic treatment or radiation. * Must be agreeable to endoscopic, and CT surveillance for a total of 24 months. * Patient's acceptance to have a tumor biopsy. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures. * LVEF assessment…
Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.
Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.
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