Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
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 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
Key facts
- Study ID
- NCT05352672
- Run by
- Regeneron Pharmaceuticals
- People needed
- 1546
- Starts
- 2022-07-14
- Expected to finish
- 2031-09-16
- Last updated by the study team
- 2026-04-22
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Angeles Clinic and Research Institute — Los Angeles, California, United States
- Orlando Health — Orlando, Florida, United States
- Seidman Cancer Center — Cleveland, Ohio, United States
- University of Tennessee Medical Center — Knoxville, Tennessee, United States
- DIABAID - Instituto de Asistencia Integral en Diabetes — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Centro Medico Austral — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Centro de Investigacion Pergamino — Pergamino, Buenos Aires, Argentina
- Instituto de Oncologia de Rosario — Rosario, Santa Fe Province, Argentina
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion) — Buenos Aires, Argentina
- Exelsus — San Miguel de Tucumán, Argentina
- Gold Coast Hospital and Health Service — Southport, Queensland, Australia
- Townsville University Hospital — Townsville, Queensland, Australia
- Calvary North Adelaide Hospital — North Adelaide, South Australia, Australia
- Icon Cancer Centre Hobart — Hobart, Tasmania, Australia
- Andrew Love Cancer Centre — Geelong, Victoria, Australia
- Alfred Hospital — Melbourne, Victoria, Australia
- University Hospital Saint Poelten — Sankt Pölten, Lower Austria, Austria
- Medical University of Graz — Graz, Styria, Austria
- Medical University Innsbruck — Innsbruck, Tyrol, Austria
- Medical University Vienna — Vienna, Austria
- AZ Groeninge — Kortrijk, West-Vlaanderen, Belgium
- AZ Nikolaas — Sint-Niklaas, West-Vlaanderen, Belgium
- Cliniques Universitaires Saint-Luc — Brussels, Belgium
- Centre Hospitalier Universitaire Universite Catholique de Louvain Namur Site Sainte Elisabeth — Namur, Belgium
- UC San Diego — La Jolla, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.