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Checkpoint Inhibitor
Fianlimab + Cemiplimab + Ipilimumab for Melanoma
Phase 2
Recruiting
Led By James Smithy, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No signs of active coronary ischemia
Calculated creatinine clearance (CrCl) ≥30 mL/min based on the Cockcroft-Gault equation
Must not have
Untreated central nervous system (CNS) metastases or leptomeningeal involvement
Uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new combination of drugs to see if it is safe and effective in treating advanced melanoma with minimal side effects."
Who is the study for?
This trial is for individuals with advanced melanoma that can't be removed by surgery or has spread, and who haven't responded to other treatments. Participants should meet certain health standards but specific inclusion and exclusion criteria are not listed.
What is being tested?
The study is examining the safety and effectiveness of combining three drugs: fianlimab, cemiplimab, and ipilimumab in treating melanoma. It aims to determine if this combination leads to fewer or milder side effects while being effective.
What are the potential side effects?
While specific side effects aren't detailed here, drugs like fianlimab, cemiplimab, and ipilimumab may cause immune-related reactions, fatigue, skin issues, digestive problems, hormonal changes or increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any symptoms of heart problems.
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My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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My side effects from previous immune therapy have mostly gone away.
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My melanoma is advanced or has spread and worsened after PD-1/PD-L1 therapy.
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My partner or I have been medically confirmed successful after a vasectomy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My brain cancer has not been treated yet.
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I do not have an uncontrolled HIV, hepatitis B, or hepatitis C infection.
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I have received specific treatments before.
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I have had heart inflammation from immune therapy before.
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I am taking higher than normal doses of steroids.
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I have not received a live vaccine in the last 30 days.
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I am currently being treated for another cancer besides the one being studied.
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I have experienced severe nerve side effects from previous immunotherapy.
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I do not have any uncontrolled illnesses or organ problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine best objective response rate (ORR) (cohort A)
Determine best objective response rate (ORR) (cohort B)
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: Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B)Experimental Treatment3 Interventions
All patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously.
Group II: Refractory melanoma after PD-1 monotherapy (Cohort A)Experimental Treatment3 Interventions
All patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470
Ipilimumab
2015
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,755 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,736 Total Patients Enrolled
James Smithy, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
43 Total Patients Enrolled