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NCT05352672 · ClinicalTrials.gov registry record · Phase 3
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
A Phase 3 study of Melanoma, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 1,546
- Enrollment target
- 20
- Study locations
NCT05352672 is a Phase 3 study of Melanoma that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,546 participants, above the 701-participant average among 266 other Melanoma trials with a reported enrollment target (121% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT05352672, a Phase 3 study of Melanoma, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,546 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. 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 drugs (which could make the drugs 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)
Buenos Aires
- DIABAID - Instituto de Asistencia Integral en Diabetes - Ciudad Autonoma de Buenos Aires
- Centro Medico Austral - Ciudad Autonoma de Buenos Aires
- Centro de Investigacion Pergamino - Pergamino
California
- UC San Diego - La Jolla
- The Angeles Clinic and Research Institute - Los Angeles
Other
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion) - Buenos Aires
- Exelsus - San Miguel de Tucumán
Queensland
- Gold Coast Hospital and Health Service - Southport
- Townsville University Hospital - Townsville
Victoria
- Andrew Love Cancer Centre - Geelong
- Alfred Hospital - Melbourne
Florida
- Orlando Health - Orlando
Ohio
- Seidman Cancer Center - Cleveland
Tennessee
- University of Tennessee Medical Center - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,546 participants |
| Start Date | 2022-07-14 |
| Est. Completion | 2031-09-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05352672
The ClinicalTrials.gov registry entry for NCT05352672 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,546 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 701-participant average among 266 other Melanoma trials with a reported enrollment target (121% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
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.
NCT05352672 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Buenos Aires, California, Other.
Frequently Asked Questions
What is clinical trial NCT05352672 about?
NCT05352672 is a clinical study titled "Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma". This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a t...
What is the current status of trial NCT05352672?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,546 participants. The study started on 2022-07-14. Estimated completion is 2031-09-16.
What conditions does trial NCT05352672 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT05352672?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Cemiplimab (DRUG), Fianlimab (DRUG).
Who is sponsoring clinical trial NCT05352672?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05352672 being conducted?
This trial has 20 study locations across California, Florida, Ohio, Tennessee, Buenos Aires. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.