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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: Active Phase 3 study of Melanoma, sponsored by Regeneron Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)
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 |
What the registry record for NCT05352672 still lists
NCT05352672 is an interventional study that assigns participants to a tested intervention. Its 1,546 participants enrollment target places it among the larger protocols in the corpus, above the 701-participant average among 266 other Melanoma trials with a reported enrollment target (121% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05352672's enrollment target sits among peer trials
1,546 13th of 266 higher than 254 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
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A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
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A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
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A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
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Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
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