Harmony Head-to-Head Study for Advanced Melanoma

This study is investigating fianlimab combined with cemiplimab for adults with advanced or metastatic melanoma (a type of skin cancer). We want to see how safe and effective this combination is compared to relatlimab plus nivolumab (Opdualag™), which is already approved for melanoma. The study will also look at potential side effects and how the drugs move through your body. You may be able to join if you are 18 or older, have advanced melanoma that hasn't been treated with prior systemic therapy, and have measurable disease. The main goal is to see how many participants respond to the treatment.

Study design
This study plans to enroll 560 participants. It is an interventional study comparing two different drug combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 72 months to assess objective response rate.

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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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Regeneron Pharmaceuticals
~560 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:fianlimabcemiplimabrelatlimab+nivolumab

At a glance

Recruiting sites
97 of 111 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)
Measured over Up to 72 months
Melanoma
111 sites across 41 states
Texas17
California11
North Carolina6
Virginia6
Florida5
Colorado4
Pennsylvania4
Tennessee4
  • Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals

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  • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)Up to 72 months