A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) (NCT06246916)
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma
🩺 Plain-English Summary (8th-Grade Level)
This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. The study is looking at several other research questions, including: * What side effects may happen from taking 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 drug less effective or could lead to side effects)
Who can join: Review the eligibility criteria below.
Location: Ironwood Cancer & Research Centers — Chandler, Arizona
Age range: 18 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 (111 Sites)
Showing the first 25 of 111 sites.
- Ironwood Cancer & Research Centers — Chandler, Arizona
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Arizona Oncology Associates — Tucson, Arizona
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Providence Medical Foundation — Fullerton, California
- Cancer and Blood Specialty Clinic — Los Alamitos, California
- University of California Los Angeles — Los Angeles, California
- St. Joseph Hospital Orange — Orange, California
- University of California Irvine, UCI Medical Center — Orange, California
- Eisenhower Medical Center — Rancho Mirage, California
- Emad Ibrahim, MD, Inc. — Redlands, California
- Sutter Health — Sacramento, California
- University of California San Francisco (UCSF) — San Francisco, California
- Sansum Clinic — Santa Barbara, California
- St John's Cancer Institute — Santa Monica, California
- Rocky Mountain Regional VA Medical Center — Aurora, Colorado
- University of Colorado Cancer Center — Aurora, Colorado
- The Melanoma And Skin Cancer Institute — Englewood, Colorado
- UCHealth — Fort Collins, Colorado
- Yale Cancer Center — New Haven, Connecticut
- Clermont Oncology Center — Clermont, Florida
- Mayo Clinic Florida — Jacksonville, Florida
- Cancer Specialist of North Florida — Jacksonville, Florida
- Boca Raton Clinical Research (BRCR) Global — Tamarac, Florida
- H. Lee Moffitt Cancer Center — Tampa, Florida
📞 Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Intervention to Improve Side Effect Management for Patients With Melanoma Receiving an Immune Checkpoint Inhibitor — Portland, Oregon
- Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY) — Houston, Texas
- Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment — Nashville, Tennessee
- Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy — San Francisco, California
- A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 — La Jolla, California
- In Vivo Real-time Detection of Circulating Melanoma Cells — Little Rock, Arkansas
Explore by condition: All Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.