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OncoMatch/Clinical Trials/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)

Is NCT06246916 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including fianlimab and cemiplimab for melanoma.

Phase 3RecruitingRegeneron PharmaceuticalsNCT06246916Data as of May 2026

Treatment: fianlimab · cemiplimab · relatlimab+nivolumabThis 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)

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: immune checkpoint inhibitor (other than anti-PD1/PD-L1)

Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol

Lab requirements

Blood counts

Kidney function

Liver function

Adequate bone marrow, hepatic, and kidney function; Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN) [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial 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

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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