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.
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.
Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason in the 5 years proceeding their colorectal cancer diagnosis.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Regeneron Pharmaceuticals
Collaborator