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 (NCT05608291)
A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk 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 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.
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 (211 Sites)
Showing the first 25 of 211 sites.
- UC San Diego — La Jolla, California
- UCSF Medical Center at Mission Bay — San Francisco, California
- John Wayne Cancer Institute (JWCI) — Santa Monica, California
- The Melanoma And Skin Cancer Institute — Englewood, Colorado
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida
- Orlando Health — Orlando, Florida
- Moffitt Cancer Center — Tampa, Florida
- Northwestern University — Chicago, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Karmanos Cancer Institute — Detroit, Michigan
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
- Columbia University — New York, New York
- University of Rochester — Rochester, New York
- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- Duke Cancer Institute, University Hospital — Durham, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio
- The Ohio State University James Comprehensive Cancer Center — Columbus, Ohio
- St Lukes University Health Network — Easton, Pennsylvania
- University Of Pittsburgh — Pittsburgh, Pennsylvania
- University of Tennessee Medical Center — Knoxville, Tennessee
- Tennessee Oncology - Centennial Clinic Location — Nashville, Tennessee
- Verdi Oncology — Nashville, Tennessee
💰 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.