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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
Study Summary
This trial compares two drugs' success in treating melanoma, looking at relapse free, overall, and melanoma-specific survival, as well as safety, quality of life, and other factors.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relapse free survival (RSF)
Secondary outcome measures
Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
Antibodies, Blocking
Serum
+19 moreTrial 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
~1340
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
617 Previous Clinical Trials
378,675 Total Patients Enrolled
13 Trials studying Melanoma
3,660 Patients Enrolled for Melanoma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
260 Previous Clinical Trials
249,512 Total Patients Enrolled
7 Trials studying Melanoma
3,155 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the combination of Fianlimab HD and Cemiplimab been granted regulatory authorization by the FDA?
"Our Power team assigned Fianlimab HD + Cemiplimab a score of 3, due to the prior evidence establishing its efficacy and multiple studies affirming its safety."
Answered by AI
Is this research group still recruiting applicants?
"Affirmative. Clinicaltrials.gov reveals that this experiment is still accepting participants, with the original posting date being January 25th 2023 and the latest update occurring on December 20th 2022. 1530 people are required for enrolment at 1 site."
Answered by AI
How many individuals are currently involved in this clinical trial?
"That is correct. The information on clinicaltrials.gov suggests that this trial, which was initially posted in late January of 2023, is now accepting participants. 1530 individuals are targeted to be recruited at a single medical centre."
Answered by AI
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