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Monoclonal Antibodies

Fianlimab + Cemiplimab 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
Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 months
Awards & highlights

Summary

"This trial is testing a new drug, fianlimab, combined with another medication, cemiplimab, to treat melanoma. They are comparing this combination with another approved treatment for melanoma

Who is the study for?
This trial is for adults with advanced or metastatic melanoma who haven't had systemic therapy for this condition. They should have a performance status indicating they can carry out light activity, and their major organs must be functioning well.
What is being tested?
The study compares the safety and effectiveness of two treatments: fianlimab combined with cemiplimab versus relatlimab plus nivolumab (Opdualag™). It also examines side effects, drug levels in blood over time, and potential immune responses to the drugs.
What are the potential side effects?
Possible side effects include reactions where the drugs are injected, fatigue, skin issues like rash or itchiness, changes in liver enzymes which may indicate liver injury, flu-like symptoms such as fever or chills, and possibly developing antibodies against the study drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My melanoma is at an advanced stage and cannot be surgically removed.
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I have not had systemic therapy for my advanced melanoma.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of laboratory abnormalities

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: fianlimab+cemiplimabExperimental Treatment2 Interventions
Randomized 1:1
Group II: relatlimab+nivolumabActive Control1 Intervention
Randomized 1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cemiplimab
2016
Completed Phase 2
~910

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
647 Previous Clinical Trials
383,658 Total Patients Enrolled
15 Trials studying Melanoma
4,752 Patients Enrolled for Melanoma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
276 Previous Clinical Trials
253,657 Total Patients Enrolled
8 Trials studying Melanoma
4,100 Patients Enrolled for Melanoma
~373 spots leftby Mar 2027
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