Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery
NCT05608291 · View on ClinicalTrials.gov ↗
Study Summary
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG Cemiplimab
- DRUG Fianlimab
Study Locations (20)
California
- UC San Diego — La Jolla
- UCSF Medical Center at Mission Bay — San Francisco
- John Wayne Cancer Institute (JWCI) — Santa Monica
Florida
- Miami Cancer Institute at Baptist Health, Inc. — Miami
- Orlando Health — Orlando
- Moffitt Cancer Center — Tampa
New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York
- Columbia University — New York
- University of Rochester — Rochester
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
- Cleveland Clinic Foundation — Cleveland
- The Ohio State University James Comprehensive Cancer Center — Columbus
Massachusetts
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
North Carolina
- Lineberger Comprehensive Cancer Center — Chapel Hill
- Duke Cancer Institute, University Hospital — Durham
Colorado
- The Melanoma And Skin Cancer Institute — Englewood
Illinois
- Northwestern University — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,564 participants |
| Start Date | 2023-01-16 |
| Est. Completion | 2030-02-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05608291
The ClinicalTrials.gov registry entry for NCT05608291 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,564 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05608291 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05608291 about?
NCT05608291 is a clinical study titled "A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery". This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The obj...
What is the current status of trial NCT05608291?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,564 participants. The study started on 2023-01-16. Estimated completion is 2030-02-15.
What conditions does trial NCT05608291 study?
This clinical trial studies the following conditions: Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05608291?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Cemiplimab (DRUG), Fianlimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05608291?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05608291 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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