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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

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 weeks
Treatment ~ Varies
Follow Up ~up to 5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 year for reporting.

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 more

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
~1340

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
647 Previous Clinical Trials
382,688 Total Patients Enrolled
15 Trials studying Melanoma
3,782 Patients Enrolled for Melanoma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
276 Previous Clinical Trials
252,687 Total Patients Enrolled
8 Trials studying Melanoma
3,130 Patients Enrolled for Melanoma

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05608291 — Phase 3
Melanoma Research Study Groups: Fianlimab HD + Cemiplimab, Fianlimab LD + Cemiplimab, Pembrolizumab
Melanoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT05608291 — Phase 3
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608291 — Phase 3
~1020 spots leftby May 2028
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