NCT05961709

The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if cemiplimab can help to control dMMR colon cancer.

Detailed description

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

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	Given by IV (vein)

Timeline

• Start date: 2024-05-20
• Primary completion: 2026-04-30
• Completion: 2028-04-30
• First posted: 2023-07-27
• Last updated: 2025-10-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study