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)
NCT ID: NCT06246916
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
560 participants
INTERVENTIONAL
2024-09-09
2033-07-10
Brief Summary
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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)
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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fianlimab+cemiplimab
Randomized 1:1
fianlimab
Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
cemiplimab
IV administration Q3W in combination with fianlimab
relatlimab+nivolumab
Randomized 1:1
relatlimab+nivolumab
IV administration every 4 weeks (Q4W)
Interventions
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fianlimab
Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
cemiplimab
IV administration Q3W in combination with fianlimab
relatlimab+nivolumab
IV administration every 4 weeks (Q4W)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
3. Measurable disease per RECIST version 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
5. Adequate bone marrow, hepatic, and kidney function
6. Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol
Exclusion Criteria
1. Uveal, acral or mucosal melanoma.
2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
3. 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:
4. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
5. Systemic immune suppression as described in the protocol.
Other Comorbidities:
6. Participants with a history of myocarditis.
7. Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
8. Active or untreated brain metastases or spinal cord compression as described in the protocol.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Providence Medical Foundation
Fullerton, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
University of California Los Angeles
Los Angeles, California, United States
St. Joseph Hospital Orange
Orange, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Sutter Health
Sacramento, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Sansum Clinic
Santa Barbara, California, United States
St John's Cancer Institute
Santa Monica, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
The Melanoma And Skin Cancer Institute
Englewood, Colorado, United States
UCHealth
Fort Collins, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Clermont Oncology Center
Clermont, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Cancer Specialist of North Florida
Jacksonville, Florida, United States
Boca Raton Clinical Research (BRCR) Global
Tamarac, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
University Cancer & Blood Center
Athens, Georgia, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Beacon Clinic
Coeur d'Alene, Idaho, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Illinois CancerCare
Peoria, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Minnesota Oncology Hematology, P.A
Fridley, Minnesota, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, United States
VA St. Louis Healthcare System
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Mercy South
St Louis, Missouri, United States
St. Vincent Healthcare
Billings, Montana, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
The Valley Hospital Inc.
Paramus, New Jersey, United States
New York Oncology Hematology
Albany, New York, United States
Messino Cancer Center
Asheville, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Novant Health Cancer Institute
Charlotte, North Carolina, United States
Novant Health Weisiger Cancer Institute - Charlotte
Charlotte, North Carolina, United States
Duke Health System
Durham, North Carolina, United States
Novant Health Zimmer Cancer Institute - Wilmington
Wilmington, North Carolina, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States
Seidman Cancer Center
Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States
Oncology Associates of Oregon PC
Eugene, Oregon, United States
Kaiser Foundation Hospitals
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
St. Luke's University Health Network
Easton, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown, Midtown Medical Center I
Austin, Texas, United States
Texas Oncology - Austin Central, Central Austin Cancer Center
Austin, Texas, United States
Texas Oncology - Bedford
Bedford, Texas, United States
Texas Oncology - Medical City
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Center For Disease And Blood Disorder
Fort Worth, Texas, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, United States
Texas Oncology - Grapevine
Grapevine, Texas, United States
Texas Oncology - Harlingen, Medical Arts Pavillion
Harlingen, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - Longview
Longview, Texas, United States
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology-Palestine Cancer Center
Palestine, Texas, United States
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States
Texas Oncology-Tyler, Northeast Texas Cancer Institute
Tyler, Texas, United States
Texas Oncology - Weslaco, Knapp Medical Plaza
Weslaco, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, United States
Swedish Cancer Institute - Issaquah Campus
Issaquah, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
London Regional Cancer Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)
Québec, , Canada
Countries
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Central Contacts
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Related Links
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Study Informational Website
Other Identifiers
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R3767-ONC-22122
Identifier Type: -
Identifier Source: org_study_id