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Cemiplimab With or Without Fianlimab for Colorectal Cancer

This study is looking at two different treatments for localized or locally advanced colorectal cancer that has a specific biomarker (a measurable indicator of a disease), called MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient). You may be eligible if you are 70 or older, or if you are 18 or older and cannot or choose not to have surgery. The study will test cemiplimab alone, or cemiplimab combined with fianlimab. Both drugs are given through an IV (intravenous, into a vein) every 21 days for a total of 4 cycles. Researchers want to see how many patients have a complete response (meaning the cancer disappears) after 6 months. The study is currently recruiting patients.

Study design
This study is an interventional trial, meaning participants will receive a specific treatment. It plans to enroll 44 participants.
What's involved
Participants will receive study drugs through an IV on Day 1 of each 21-day cycle, for a total of 4 cycles of treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 months, indicating follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06205836

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~44 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:CemiplimabFianlimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Response Rate
Measured over 6 Months

Conditions

Colorectal Cancer

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Colorectal CarcinomaMRC1 wt AlleleMSI1 Gene

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Eric Christenson, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution

Who to contact

Colleen Apostal, RN
[email protected]
410-614-3644
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥70 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
Must not have received any prior systemic treatment or radiation.
Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
Patient's acceptance to have a tumor biopsy.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
LVEF assessment with documented LVEF ≥ 45% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.
For both Women and Men, must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 -3.
Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
Patient deemed a poor surgical candidate after evaluation by a surgeon or unwilling to undergo surgery.
Must not have received any prior systemic treatment or radiation.
Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
Patient's acceptance to have a tumor biopsy.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
For both Women and Men, must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.

Exclusion

Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
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.
Currently using any chronic systemic steroids.
Patient has received a live vaccine within 30 days of the first dose of study drug.
History of severe hypersensitivity reaction to any monoclonal antibody.
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
Active autoimmune disease.
Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
Patient has a pulse oximetry of \<92% on room air.
Patient is on supplemental home oxygen.
Has clinically significant heart disease.
Cohort B Only: Troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline.
Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
Unwilling or unable to follow the study schedule for any reason
Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
Currently using any chronic systemic steroids.
Patient has received a live vaccine within 30 days of the first dose of study drug.
History of severe hypersensitivity reaction to any monoclonal antibody.
Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
Patient is pregnant or breastfeeding.
Cohort D Only: Troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline.
Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
Participation deemed not in the best interest of the patient.
Unwilling or unable to follow the study schedule for any reason.

What this trial measures

  • Complete Response Rate6 Months

    Proportion of subjects with either a pathologic complete response (pCR) at the time of surgery OR a clinical complete response (cCR) at 6 months for those subjects who do not undergo surgery. pCR is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen. cCR is defined as an absence of visible disease on CT imaging by RECIST 1.1 and endoscopic evaluation.