The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMM… (NCT05961709) | Clinical Trial Compass
Active — Not RecruitingPhase 2
The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer
United States50 participantsStarted 2024-05-20
Plain-language summary
To learn if cemiplimab can help to control dMMR colon cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 cou…
What they're measuring
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: Through study completion; an average of 1 year