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NCT05608291 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Melanoma, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 1,564
- Enrollment target
- 20
- Study locations
NCT05608291 is a Phase 3 study of Melanoma that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,564 participants, above the 701-participant average among 266 other Melanoma trials with a reported enrollment target (123% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT05608291, 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
- 1,564 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 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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,564 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 (123% 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.
NCT05608291 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, New York.
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.
What interventions are being tested in trial NCT05608291?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Cemiplimab (DRUG), Fianlimab (DRUG).
Who is sponsoring clinical trial NCT05608291?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
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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.