RecruitingPhase 2NCT05961709

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

50 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called the Phoenix Trial — is testing whether cemiplimab (an immunotherapy drug) can treat localized colon cancer that has a genetic feature called mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) without requiring surgery. This approach could allow some patients to avoid major colon surgery. **You may be eligible if...** - You are 18 or older with a confirmed colon adenocarcinoma (at least 10 cm from the anal canal) that is dMMR or MSI-H - Your cancer is localized (Stage II or III) or locally recurrent - Your overall health is good (ECOG 0–1) and the tumor is accessible by colonoscopy **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You have an active autoimmune disease requiring systemic treatment in the past year - You have previously received immunotherapy (checkpoint inhibitor) for your colon cancer - You are currently receiving chemotherapy or other cancer treatment - You are pregnant or breastfeeding - You have a history of severe lung inflammation requiring steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab

Given by IV (vein)


Locations(5)

Banner - MD Anderson Cancer

Gilbert, Arizona, United States

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, United States

Ochsner

New Orleans, Louisiana, United States

Cooper University Medical Center

Camden, New Jersey, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05961709


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