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.
Treatment: fianlimab · cemiplimab · relatlimab+nivolumab — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
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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