The Phoenix Trial: Phase II Study of Cemiplimab for Non-Surgical Treatment of Localized dMMR Colon Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05961709

Provider View

This clinical trial is exploring whether the drug cemiplimab can effectively manage colon cancer that is dMMR, without the need for surgery. The study aims to see if this approach can help control the cancer and improve patient outcomes.

Patient Parameters

Program Overview

The purpose of this study is to find out if cemiplimab can help control colon cancer that is deficient in mismatch repair (dMMR). Researchers are looking at whether this drug can be used as a non-surgical treatment option for patients with localized colon cancer. The study will measure how well the cancer responds to the treatment and whether it can help patients avoid surgery.

Description

The main goal of this study is to see if using cemiplimab can help patients with localized dMMR colon cancer avoid surgery. Researchers will look at how many patients have no signs of cancer in their colon after six months of treatment. They will also explore other outcomes, such as how many patients can avoid surgery after one year and how the cancer responds to the treatment on scans and endoscopy.

The study will also assess the safety of cemiplimab and how it affects patients' symptoms. Researchers will collect blood samples to study changes in DNA and immune cells to see if they can predict how well the treatment works. They will also compare gene expression in cancer cells before and after treatment to understand how the drug affects the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of colon cancer that is dMMR or MSI-H.
  • Cancer must be localized and meet specific staging criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Tumor must be accessible for endoscopic evaluation.
  • Have measurable or non-measurable disease on scans.
  • Meet specific blood test criteria for neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, and creatinine.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception during the study and for four months after.
  • Willing to return for follow-up visits and provide blood samples for research.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Not fully recovered from previous treatments.
  • Have serious health conditions that could interfere with the study.
  • Have an active infection or require continuous oxygen therapy.
  • Be immunocompromised or have uncontrolled HIV.
  • Be receiving other cancer treatments.
  • Be pregnant, breastfeeding, or planning to conceive during the study.
  • Have had recent surgery, chemotherapy, or radiation therapy.
  • Have received certain immune therapies for colon cancer.
  • Have other cancers that could affect the study.
  • Have known metastatic disease.
  • Have active autoimmune disease requiring treatment in the past year.
  • Have a history of lung inflammation requiring steroids.

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