Actively Recruiting
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-05-06
44
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The 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.
CONDITIONS
Official Title
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older for Cohorts A and B; age 18 years or older for Cohorts C and D
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 for Cohorts A and B; 0 to 3 for Cohorts C and D
- Histologically confirmed localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer
- No prior systemic treatment or radiation for colorectal cancer
- Agreeable to endoscopic and CT surveillance for a total of 24 months
- Willingness to have a tumor biopsy
- Adequate organ and marrow function based on study laboratory tests
- Left ventricular ejection fraction (LVEF) of 45% or greater documented by TTE or MUGA within 6 months before first study drug
- Use of acceptable birth control methods during the study for both women and men
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Use of investigational agents or devices within 28 days before first study drug dose
- Expected need for other systemic or localized antineoplastic therapy during study
- Surgery within 28 days before dosing except minor procedures
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies within 5 years before colorectal cancer diagnosis
- Current use of chronic systemic steroids
- Receipt of live vaccine within 30 days before first study drug dose
- History of severe hypersensitivity to any monoclonal antibody
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, metastatic cancer, or psychiatric/social conditions limiting compliance
- Active autoimmune disease
- Any tissue or organ allograft including corneal allograft
- Pulse oximetry below 92% on room air
- Use of supplemental home oxygen
- Clinically significant heart disease
- Elevated troponin T or I over 2 times institutional upper limit of normal at baseline (Cohort B and D specific)
- Conditions such as alcohol or drug dependence, intercurrent illness, or insufficient venous access limiting compliance
- Pregnancy or breastfeeding (Cohorts C and D)
- Participation not in patient's best interest
- Unwillingness or inability to follow study schedule
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins SKCCC
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
C
Colleen Apostal, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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