OncoMatch/Clinical Trials/NCT05961709
The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer
Is NCT05961709 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cemiplimab for colon cancer.
Treatment: Cemiplimab — To learn if cemiplimab can help to control dMMR colon cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 loss (complete tumor nuclear loss)
Immunohistochemistry-determined dMMR by complete tumor nuclear loss of MLH1, PMS2, MSH2 or MSH6
Required: PMS2 loss (complete tumor nuclear loss)
Immunohistochemistry-determined dMMR by complete tumor nuclear loss of MLH1, PMS2, MSH2 or MSH6
Required: MSH2 loss (complete tumor nuclear loss)
Immunohistochemistry-determined dMMR by complete tumor nuclear loss of MLH1, PMS2, MSH2 or MSH6
Required: MSH6 loss (complete tumor nuclear loss)
Immunohistochemistry-determined dMMR by complete tumor nuclear loss of MLH1, PMS2, MSH2 or MSH6
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Exception: for colon cancer
Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) for colon cancer
Cannot have received: chemotherapy
Exception: ≤2 weeks prior to study treatment
Chemotherapy ≤2 weeks prior to study treatment
Cannot have received: radiation therapy
Exception: ≤2 weeks prior to study treatment
Radiation therapy ≤2 weeks prior to study treatment
Cannot have received: surgery
Exception: ≤3 weeks prior to study treatment
Surgery ≤3 weeks prior to study treatment
Lab requirements
Blood counts
ANC ≥1000/mm3; Platelet count >80,000/mm3; Hemoglobin >8 g/dL
Kidney function
Creatinine <2.0 mg/dL
Liver function
Total bilirubin ≤1.5 x ULN [for patients with Gilberts disease criteria is direct bilirubin ≤1.5 x ULN]; ALT and AST ≤3 x ULN
Laboratory values (obtained within 7 days prior to registration) meeting the following criteria: ANC ≥1000/mm3; Platelet count >80,000/mm3; Hemoglobin >8 g/dL; Total bilirubin ≤1.5 x ULN [for patients with Gilberts disease criteria is direct bilirubin ≤1.5 x ULN]; ALT and AST ≤3 x ULN; Creatinine <2.0 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner - MD Anderson Cancer · Gilbert, Arizona
- Baptist - MD Anderson Cancer Center · Jacksonville, Florida
- Ochsner · New Orleans, Louisiana
- Cooper University Medical Center · Camden, New Jersey
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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