Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma (NCT05352672)
A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: UC San Diego — La Jolla, California
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (210 Sites)
Showing the first 25 of 210 sites.
- UC San Diego — La Jolla, California
- The Angeles Clinic and Research Institute — Los Angeles, California
- Orlando Health — Orlando, Florida
- Seidman Cancer Center — Cleveland, Ohio
- University of Tennessee Medical Center — Knoxville, Tennessee
- DIABAID - Instituto de Asistencia Integral en Diabetes — Ciudad Autonoma de Buenos Aires, Buenos Aires
- Centro Medico Austral — Ciudad Autonoma de Buenos Aires, Buenos Aires
- Centro de Investigacion Pergamino — Pergamino, Buenos Aires
- Instituto de Oncologia de Rosario — Rosario, Santa Fe Province
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion) — Buenos Aires,
- Exelsus — San Miguel de Tucumán,
- Gold Coast Hospital and Health Service — Southport, Queensland
- Townsville University Hospital — Townsville, Queensland
- Calvary North Adelaide Hospital — North Adelaide, South Australia
- Icon Cancer Centre Hobart — Hobart, Tasmania
- Andrew Love Cancer Centre — Geelong, Victoria
- Alfred Hospital — Melbourne, Victoria
- University Hospital Saint Poelten — Sankt Pölten, Lower Austria
- Medical University of Graz — Graz, Styria
- Medical University Innsbruck — Innsbruck, Tyrol
- Medical University Vienna — Vienna,
- AZ Groeninge — Kortrijk, West-Vlaanderen
- AZ Nikolaas — Sint-Niklaas, West-Vlaanderen
- Cliniques Universitaires Saint-Luc — Brussels,
- Centre Hospitalier Universitaire Universite Catholique de Louvain Namur Site Sainte Elisabeth — Namur,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma
- Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy — San Francisco, California
- An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) — Tucson, Arizona
- Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. — CABA, Buenos Aires
- Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients — Santa Monica, California
- NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma — Boston, Massachusetts
- A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma — Orlando, Florida
Explore by condition: All Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.