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Monoclonal Antibodies
Fianlimab + Cemiplimab vs Pembrolizumab for Melanoma
Phase 3
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 year
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new drug combination in patients at high risk of melanoma coming back after surgery. The drugs aim to help the immune system fight any remaining cancer cells better than the current treatment.
Who is the study for?
This trial is for adults who've had melanoma surgically removed recently and are disease-free. They must have been stage IIC, III, or IV at diagnosis per AJCC 8th edition criteria. Excluded are those with uveal melanoma, any remaining disease post-surgery, significant autoimmune diseases in the past 2 years needing immunosuppressants, adolescents under 40 kg, and uncontrolled HIV/HBV/HCV infections.
What is being tested?
The study aims to see if fianlimab combined with cemiplimab increases the time patients remain free from melanoma relapse compared to pembrolizumab alone. It will also compare overall survival rates, specific survival rates for melanoma, effects on metastasis-free survival after surgery, quality of life impacts and safety between the two treatments.
What are the potential side effects?
Potential side effects may include immune system reactions that can affect organs like lungs or intestines (inflammation), skin reactions at injection sites, fatigue or weakness; however individual experiences may vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Relapse free survival (RSF)
Secondary study objectives
Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
Antibodies, Blocking
Serum
+16 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Fianlimab LD + CemiplimabExperimental Treatment2 Interventions
Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab
Group II: Fianlimab HD + CemiplimabExperimental Treatment2 Interventions
Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab
Group III: PembrolizumabActive Control2 Interventions
Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo
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?
Regeneron PharmaceuticalsLead Sponsor
668 Previous Clinical Trials
384,543 Total Patients Enrolled
16 Trials studying Melanoma
3,815 Patients Enrolled for Melanoma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
283 Previous Clinical Trials
253,552 Total Patients Enrolled
8 Trials studying Melanoma
3,075 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma is stage IIB to IV and has been fully removed by surgery.I still have signs of cancer after surgery.I have been treated for an autoimmune disease in the last 2 years.I am a teenager between 12 and 18 years old and weigh less than 40 kg.I have had myocarditis in the past.I have been diagnosed with uveal melanoma.I had surgery to remove my cancer and healed well within the last 12 weeks.My recent tests show no signs of cancer.I do not have an uncontrolled HIV, HBV, or HCV infection or a related immunodeficiency.I have not had any other cancer that is getting worse or needed treatment in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Fianlimab HD + Cemiplimab
- Group 2: Fianlimab LD + Cemiplimab
- Group 3: Pembrolizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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