The Phoenix Trial: Cemiplimab for Patients with Localized dMMR Colon Cancer

About the Study

This study will examine the effectiveness and safety of cemiplimab, a treatment given prior to surgery. Participants will undergo endoscopy after the therapy and take CT scans to assess the effects of the therapy. The study also will compare genes of pretreatment cancer samples between patients who responded well to the therapy and patients who did not.

What the Study Involves

Participants will receive Cemiplimab injected into the vein over 30 minutes on the first day of each 3-week cycle of the study, for up to 8 cycles.

Study Site

Texas

MD Anderson Cancer Center
Houston, Texas 77030

Lead Investigator

Dr. Michael Overman

People, 18 years old and older, who meet all the following criteria.

• Have colon cancer that is deficient in mismatch repair (dMMR) or microsatellite instability high (MSI-H)
• Have localized colon cancer (cancer that has not spread to other parts of the body)
• Have tumor that is evaluated by endoscopic test
• Are willing to undergo repeated endoscopic tests
• (Women who are potential childbearing) have negative pregnancy tests within 7 days prior to the study enrollment  
• Use contraception prior to study enrollment, duration of study and 4 months after taking the last cemiplimab
• Are willing to visit an enrolling hospital for follow-up
• Are willing to provide blood samples
• Give informed consent
• Are able to follow study instructions

People under 18 years old who:

• Do not recover from side effects of prior therapy
• Have other severe diseases including heart diseases, active infection and respiratory disease that require oxygen therapy
• Have HIV infection and currently take medication
• Are receiving other medication of clinical trial, or other therapy including chemotherapy for colon cancer
• People who are pregnant or breastfeeding
• Are willing to have children during the study or within 120 days after the last treatment
• Undergo surgery within 3 weeks prior to the study treatment
• Receive chemotherapy within 2 weeks prior to the study treatment
• Undergo radiation therapy 2 weeks prior to the study treatment
• Receive prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD L2 agent
• Have a prior or concurrent cancer that interfere with the assessment of safety and effectiveness for the study treatment
• Have metastatic cancer excluding lymph nodes metastasis
• Have active autoimmune disease that required treatment within one year
• Have a history of pneumonitis that required steroids