Colon Cancer Clinical Trial
Official title:
The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer
To learn if cemiplimab can help to control dMMR colon cancer.
Primary Objective: •To assess feasibility and success of an organ-sparing strategy in patients with localized dMMR colorectal cancer receiving neoadjuvant cemiplimab. The primary endpoint is rate of endoCR by 6 months. Exploratory Objectives: - To quantify organ-sparing rate at 1 year for all patients treated with one dose of cemiplimab (intent to treat) - To quantify the composite rate of either non-operative management at 1 year or pathological complete response for all patients treated with one dose of cemiplimab (intent to treat) - To quantify the composite rate of either endoCR by 6 months or pathologic complete response for all patients treated with one dose of cemiplimab (intent to treat) - To assess and describe features observed on endoscopy after neoadjuvant cemiplimab - To assess radiographic response to neoadjuvant cemiplimab - To estimate the relapse-free survival, progression-free survival and overall survival in all enrolled participants - To determine the overall rates of pathological response to neoadjuvant cemiplimab in patients who undergo resection after receiving at least one dose of cemiplimab - To determine overall safety of cemiplimab for patients with localized colon cancer - To determine the change in patient-reported symptoms with cemiplimab - To explore the predictive ability of changes in ctDNA for efficacy endpoints - To determine if total mutational burden and genomic alterations correlate with response and extent of benefit from cemiplimab - To correlate tumor-immune microenvironment (for example T-effector cell populations; CD4 subsets; T-regulatory populations; B cell populations; dendritic and macrophage populations) in pre-treatment tumor samples with efficacy endpoints - To compare targeted gene expression profiles of immune-related genes and genes pertaining to common cancer signaling pathways in pre-treatment samples as well as the change in these factors (for cases with both pre-treatment and on-treatment tumor samples) between responders and non-responders ;
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