Taking people in United StatesPhase 3

Compares fianlimab and cemiplimab with relatlimab and nivolumab for melanoma

Tests fianlimab with cemiplimab against relatlimab and nivolumab in adults with melanoma.

Plain-language title generated from the registry record
Registry title: 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)

Key facts

Where: Albany, Ann Arbor, Asheville, Athens, Aurora, Austin, Baton Rouge, Bedford, Billings, Chandler, Charlotte, Charlottesville, Chattanooga, Cincinnati, Clermont, Cleveland, Coeur d'Alene, Columbia, Columbus, Dallas, Detroit, Durham, Easton, Edmonds, Englewood, Eugene, Fairfax, Fort Collins, Fort Wayne, Fort Worth, Fridley, Fullerton, Gilbert, Grapevine, Greenville, Hackensack, Harlingen, Hershey, Hinsdale, Houston, Issaquah, Jacksonville, Kennewick, Knoxville, Las Vegas, Lebanon, Lexington, Little Rock, Longview, Los Alamitos, Los Angeles, Lubbock, Madison, McAllen, Minneapolis, Morgantown, Nashville, New Brunswick, New Haven, Norfolk, Omaha, Orange, Palestine, Paramus, Park Ridge, Peoria, Philadelphia, Pittsburgh, Portland, Providence, Rancho Mirage, Redlands, Richmond, Roanoke, Sacramento, Salt Lake City, San Francisco, Santa Barbara, Santa Monica, Seattle, St Louis, Tamarac, Tampa, Tucson, Tulsa, Tyler, Weslaco, Westwood, and Wilmington, United StatesSee the 106 sites
Phase: Phase 3

Where in United States

New York Oncology HematologyAlbany, United StatesTaking people
University of MichiganAnn Arbor, United StatesTaking people
Messino Cancer CenterAsheville, United StatesTaking people
University Cancer & Blood CenterAthens, United StatesTaking people
Rocky Mountain Regional VA Medical CenterAurora, United StatesTaking people
University of Colorado Cancer CenterAurora, United StatesTaking people
Texas Oncology - Austin Central, Central Austin Cancer CenterAustin, United StatesTaking people
Texas Oncology - Austin Midtown, Midtown Medical Center IAustin, United StatesTaking people
Texas Oncology - South Austin, South Austin Cancer CenterAustin, United StatesTaking people
Mary Bird Perkins Cancer CenterBaton Rouge, United StatesNo longer taking part
Texas Oncology - BedfordBedford, United StatesTaking people
St. Vincent HealthcareBillings, United StatesNo longer taking part
Ironwood Cancer & Research CentersChandler, United StatesTaking people
Levine Cancer InstituteCharlotte, United StatesTaking people
Novant Health Cancer InstituteCharlotte, United StatesTaking people
Novant Health Weisiger Cancer Institute - CharlotteCharlotte, United StatesTaking people
University of VirginiaCharlottesville, United StatesTaking people
Tennessee Oncology - ChattanoogaChattanooga, United StatesTaking people
Oncology Hematology Care Clinical TrialsCincinnati, United StatesNo longer taking part
Clermont Oncology CenterClermont, United StatesNo longer taking part
Seidman Cancer CenterCleveland, United StatesTaking people
Beacon ClinicCoeur d'Alene, United StatesTaking people
Maryland Oncology Hematology P.A.Columbia, United StatesTaking people
The Ohio State University -Wexner Medical CenterColumbus, United StatesTaking people
John B Amos Cancer CenterColumbus, United StatesNo longer taking part
Texas OncologyDallas, United StatesTaking people
Texas Oncology - Medical CityDallas, United StatesTaking people
Henry Ford Cancer Institute/Henry Ford Health SystemDetroit, United StatesTaking people
Karmanos Cancer InstituteDetroit, United StatesNo longer taking part
Duke Health SystemDurham, United StatesTaking people
St. Luke's University Health NetworkEaston, United StatesTaking people
Swedish Cancer Institute - Edmonds CampusEdmonds, United StatesTaking people
The Melanoma and Skin Cancer InstituteEnglewood, United StatesTaking people
USOR - Willamette Valley Cancer Institute and Research CenterEugene, United StatesTaking people
Inova Schar Cancer InstituteFairfax, United StatesTaking people
Virginia Cancer Specialists PCFairfax, United StatesNo longer taking part
UCHealthFort Collins, United StatesNo longer taking part
Fort Wayne Medical Oncology and HematologyFort Wayne, United StatesTaking people
Texas Oncology, Fort WorthFort Worth, United StatesTaking people
Center For Disease And Blood DisorderFort Worth, United StatesNo longer taking part
Minnesota Oncology Hematology, P.A.Fridley, United StatesTaking people
Providence Medical FoundationFullerton, United StatesTaking people
Banner MD Anderson Cancer CenterGilbert, United StatesTaking people
Texas Oncology GrapevineGrapevine, United StatesTaking people
Saint Francis Cancer CenterGreenville, United StatesNo longer taking part
John Theurer Cancer CenterHackensack, United StatesTaking people
Texas Oncology - Harlingen, Medical Arts PavillionHarlingen, United StatesTaking people
Penn State Health Milton South Hershey Medical CenterHershey, United StatesTaking people
Hope and Healing Cancer ServicesHinsdale, United StatesTaking people
The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
Swedish Cancer Institute - Issaquah CampusIssaquah, United StatesTaking people
Mayo Clinic FloridaJacksonville, United StatesTaking people
Cancer Specialist of North FloridaJacksonville, United StatesNo longer taking part
Kadlec Clinic Hematology and OncologyKennewick, United StatesTaking people
University of Tennessee Medical CenterKnoxville, United StatesTaking people
Comprehensive Cancer Centers of NevadaLas Vegas, United StatesTaking people
Dartmouth Hitchcock Medical CenterLebanon, United StatesTaking people
Markey Cancer Center Clinical Research OrganizationLexington, United StatesNo longer taking part
University of Arkansas for Medical SciencesLittle Rock, United StatesNo longer taking part
Texas Oncology - LongviewLongview, United StatesTaking people
Cancer and Blood Specialty ClinicLos Alamitos, United StatesTaking people
University of California, Los AngelesLos Angeles, United StatesTaking people
Joe Arrington Cancer Research Treatment CenterLubbock, United StatesTaking people
University of Wisconsin Carbone Cancer CenterMadison, United StatesTaking people
Texas Oncology-McAllenMcAllen, United StatesTaking people
Allina Health Cancer InstituteMinneapolis, United StatesNo longer taking part
West Virginia UniversityMorgantown, United StatesTaking people
Sarah Cannon Research Institute (SCRI) Oncology PartnersNashville, United StatesTaking people
Tennessee OncologyNashville, United StatesTaking people
Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
Yale Cancer CenterNew Haven, United StatesTaking people
Virginia Oncology AssociatesNorfolk, United StatesNo longer taking part
Oncology Hematology West P.C. dba Nebraska Cancer SpecialistsOmaha, United StatesTaking people
St. Joseph Hospital OrangeOrange, United StatesTaking people
University of California - Irvine/UCI Medical CenterOrange, United StatesTaking people
Texas Oncology-Palestine Cancer CenterPalestine, United StatesTaking people
The Valley Hospital, Inc.Paramus, United StatesTaking people
Advocate Lutheran General HospitalPark Ridge, United StatesTaking people
Illinois CancerCarePeoria, United StatesTaking people
Fox Chase Cancer CenterPhiladelphia, United StatesTaking people
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterPittsburgh, United StatesTaking people
Kaiser Foundation HospitalsPortland, United StatesTaking people
Oregon Health and Science UniversityPortland, United StatesTaking people
Lifespan Cancer InstituteProvidence, United StatesTaking people
Eisenhower Medical CenterRancho Mirage, United StatesNo longer taking part
Emad Ibrahim, MD, Inc.Redlands, United StatesTaking people
Virginia Commonwealth University/Massey Cancer CenterRichmond, United StatesTaking people
Oncology & Hematology Associates of Southwest Virginia, Inc.Roanoke, United StatesTaking people
Sutter HealthSacramento, United StatesTaking people
University of Utah - Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
University of California, San Francisco (UCSF)San Francisco, United StatesTaking people
Sansum ClinicSanta Barbara, United StatesNo longer taking part
St John's Cancer InstituteSanta Monica, United StatesNo longer taking part
Swedish Cancer InstituteSeattle, United StatesTaking people
Mercy SouthSt Louis, United StatesTaking people
VA St. Louis Healthcare SystemSt Louis, United StatesTaking people
Washington University School of MedicineSt Louis, United StatesTaking people
Boca Raton Clinical Research (BRCR) GlobalTamarac, United StatesTaking people
H Lee Moffitt Cancer CenterTampa, United StatesTaking people
Arizona Oncology AssociatesTucson, United StatesNo longer taking part
Oklahoma Cancer Specialists and Research Institute, LLCTulsa, United StatesTaking people
Texas Oncology-Tyler, Northeast Texas Cancer InstituteTyler, United StatesNo longer taking part
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer CenterTyler, United StatesNo longer taking part
Texas Oncology - Weslaco, Knapp Medical PlazaWeslaco, United StatesTaking people
The University of Kansas Cancer CenterWestwood, United StatesTaking people
Novant Health Zimmer Cancer Institute - WilmingtonWilmington, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Print a page for my doctor

Trial details

Who runs it: Regeneron Pharmaceuticals
Trial code: NCT06246916
Record updated: 6 November 2026
Original description: 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.Read full original descriptionShow less
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma
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)
Inclusion: Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition; Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol; Measurable disease per RECIST version 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1; Adequate bone marrow, hepatic, and kidney function; Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol.
Exclusion: Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol; Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed; Prior/Concomitant Therapy:; Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol; Medical Conditions:; Participants with a history of myocarditis; Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN); Uveal, acral or mucosal melanoma; Systemic immune suppression as described in the protocol; Other Comorbidities:; Active or untreated brain metastases or spinal cord compression as described in the protocol; Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
ClinicalTrials.gov NCT06246916