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Checkpoint Inhibitor
Cemiplimab + Fianlimab for Colorectal Cancer
Phase 2
Recruiting
Led By Eric Christenson, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥70 years
Histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to assess the safety and effectiveness of two drugs, cemiplimab and cemiplimab/fianlimab combination, in treating a specific type of colorectal cancer in
Who is the study for?
This trial is for patients aged 70 or older with localized or locally advanced colorectal cancer that's microsatellite instability-high (MSI-H). Specific eligibility details are not provided, but typically participants must be in good health aside from their cancer and meet certain lab criteria.
What is being tested?
The study is testing the effectiveness and safety of cemiplimab alone, versus a combination of cemiplimab with fianlimab. It aims to see how well these treatments work in older adults with a specific type of colorectal cancer.
What are the potential side effects?
While specific side effects aren't listed here, drugs like cemiplimab and fianlimab can cause immune-related reactions, skin issues, fatigue, digestive problems, liver inflammation, hormone gland changes among other potential side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 70 years old or older.
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My colorectal cancer is confirmed to be mismatch repair deficient or has high microsatellite instability.
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I have not had any previous systemic treatment or radiation.
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I agree to have a tumor biopsy.
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I am able to get out of my bed or chair and move around.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with specific immune therapies before my colorectal cancer diagnosis.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I use supplemental oxygen at home.
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I have had an organ or tissue transplant.
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I haven't had major surgery in the last 28 days.
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I have a serious heart condition.
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I am currently taking long-term steroid medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response Rate
Secondary study objectives
Number of participants experiencing grade 3 or above drug-related toxicities requiring treatment discontinuation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B - Cemiplimab with FianlimabExperimental Treatment2 Interventions
Group II: Cohort A - CemiplimabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
571 Previous Clinical Trials
33,331 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,802 Total Patients Enrolled
Eric Christenson, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution
1 Previous Clinical Trials
25 Total Patients Enrolled