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OncoMatch/Clinical Trials/NCT06205836

Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Is NCT06205836 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cemiplimab and Fianlimab for colorectal cancer.

Phase 2RecruitingSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNCT06205836Data as of May 2026

Treatment: Cemiplimab · FianlimabThe purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater or in patients age 18 or greater considered poor candidates for surgery or unwilling to undergo surgery.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Must not have received any prior systemic treatment

Cannot have received: radiation therapy

Must not have received any prior...radiation

Cannot have received: anti-PD-1 therapy

History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason in the 5 years proceeding their colorectal cancer diagnosis

Lab requirements

Blood counts

adequate organ and marrow function defined by study-specified laboratory tests and procedures

Kidney function

adequate organ and marrow function defined by study-specified laboratory tests and procedures

Liver function

adequate organ and marrow function defined by study-specified laboratory tests and procedures

Cardiac function

lvef assessment with documented lvef ≥ 45% by either tte or muga (tte preferred) within 6 months from first study drug administration

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Johns Hopkins SKCCC · Baltimore, Maryland

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