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
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Melanoma
In brief
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.
Key facts
- Study ID
- NCT05608291
- Run by
- Regeneron Pharmaceuticals
- People needed
- 1564
- Starts
- 2023-01-16
- Expected to finish
- 2030-04-03
- Last updated by the study team
- 2026-07-06
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCSF Medical Center at Mission Bay — San Francisco, California, United States
- John Wayne Cancer Institute (JWCI) — Santa Monica, California, United States
- The Melanoma And Skin Cancer Institute — Englewood, Colorado, United States
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
- Orlando Health — Orlando, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
- Columbia University — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- Duke Cancer Institute, University Hospital — Durham, North Carolina, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- The Ohio State University James Comprehensive Cancer Center — Columbus, Ohio, United States
- St Lukes University Health Network — Easton, Pennsylvania, United States
- University Of Pittsburgh — Pittsburgh, Pennsylvania, United States
- University of Tennessee Medical Center — Knoxville, Tennessee, United States
- Tennessee Oncology - Centennial Clinic Location — Nashville, Tennessee, United States
- Verdi Oncology — Nashville, Tennessee, United States
- UC San Diego — La Jolla, California, United States
Full record on ClinicalTrials.gov
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