NCT06246916

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)

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	fianlimab	Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
DRUG	cemiplimab	IV administration Q3W in combination with fianlimab
DRUG	relatlimab+nivolumab	IV administration every 4 weeks (Q4W)

Timeline

• Start date: 2024-09-09
• Primary completion: 2027-03-22
• Completion: 2033-07-10
• First posted: 2024-02-07
• Last updated: 2026-02-19

Locations

108 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study