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

NCT05961709 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0228NCI-2023-05749
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Cemiplimab

EXPERIMENTAL

Participants will receive cemiplimab by vein over about 30 minutes on Day 1 of each 3-week study cycle, up to 8 cycles.

Drug: Cemiplimab

Interventions

Cemiplimab DRUG

Given by IV (vein)

Cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Age ≥18 years
• Histological confirmation of colon adenocarcinoma, as determined by pathology review (inferior colon margin defined as \>10 cm from anal verge).
• Colon cancer that is deficient in mismatch repair (dMMR) or microsatellite Instability high (MSI-H) as determined by one of three methods:
• Immunohistochemistry-determined dMMR by complete tumor nuclear loss of MLH1, PMS2, MSH2 or MSH6
• PCR-determined MSI at \>30% of tested microsatellites
• Next-generation-determined MSI-H based upon instability at multiple microsatellites as determined by the specific next generation sequencing panel
• Localized colon cancer with (1) radiological staging of T3 or T4 or lymph node positive (stage II or III) OR (2) locally recurrent with luminal component OR (3) stage I with a surgical mortality defined as \>5% by American College of Surgeons (ACS) National Surgery Quality Improvement Program
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Primary tumor that is deemed to be accessible by endoscopic intervention and willingness to undergo repeated endoscopic evaluations
• Measurable or non-measurable disease by cross-sectional imaging per RECIST v1.1 criteria
• Laboratory values (obtained within 7 days prior to registration) meeting the following criteria:
• Absolute neutrophil count (ANC) ≥1000/mme
• Platelet count \>80,000/mm3
• Hemoglobin \>8 g/dL

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 1 or 2 peripheral (sensory) neuropathy or alopecia
• Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens; conditions including but not limited to:
• symptomatic congestive heart failure
• unstable angina pectoris
• cardiac arrhythmia
• ongoing or active infection
• psychiatric illness/social situations
• dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
• any other conditions that would limit compliance with study requirements
• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy without undetectable viral load. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
• Receiving any other investigational agent, chemotherapy or other targeted therapy that would be considered as a treatment for the colon cancer.
• Because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown, the following are not eligible for participation in this trial:
• Pregnant persons
• Nursing persons

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (5)

Banner - MD Anderson Cancer

Gilbert, Arizona, 85234, United States

Location

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Ochsner

New Orleans, Louisiana, 70121, United States

Location

Cooper University Medical Center

Camden, New Jersey, 08103, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Michael Overman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: May 20, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (5)