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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)

NCT06246916 · Regeneron Pharmaceuticals
In plain English

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Official title
A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma
About this study
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)
Eligibility criteria
Key Inclusion Criteria: 1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition. 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 Key Exclusion Criteria: Medical Conditions: 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. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Study design
Enrollment target: 560 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-09
Estimated completion: 2033-07-10
Last updated: 2026-02-19
Interventions
Drug: fianlimabDrug: cemiplimabDrug: relatlimab+nivolumab
Primary outcomes
  • 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)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (108)
Ironwood Cancer & Research CentersRecruiting
Chandler, Arizona, United States
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
Arizona Oncology AssociatesWithdrawn
Tucson, Arizona, United States
University of Arkansas for Medical SciencesRecruiting
Little Rock, Arkansas, United States
Providence Medical FoundationRecruiting
Fullerton, California, United States
Cancer and Blood Specialty ClinicRecruiting
Los Alamitos, California, United States
University of California Los AngelesRecruiting
Los Angeles, California, United States
St. Joseph Hospital OrangeRecruiting
Orange, California, United States
Eisenhower Medical CenterRecruiting
Rancho Mirage, California, United States
Emad Ibrahim, MD, Inc.Recruiting
Redlands, California, United States
Sutter HealthRecruiting
Sacramento, California, United States
University of California San Francisco (UCSF)Recruiting
San Francisco, California, United States
Sansum ClinicRecruiting
Santa Barbara, California, United States
St John's Cancer InstituteRecruiting
Santa Monica, California, United States
Rocky Mountain Regional VA Medical CenterRecruiting
Aurora, Colorado, United States
University of Colorado Cancer CenterRecruiting
Aurora, Colorado, United States
The Melanoma And Skin Cancer InstituteRecruiting
Englewood, Colorado, United States
UCHealthRecruiting
Fort Collins, Colorado, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Clermont Oncology CenterRecruiting
Clermont, Florida, United States
Mayo Clinic FloridaRecruiting
Jacksonville, Florida, United States
Cancer Specialist of North FloridaRecruiting
Jacksonville, Florida, United States
Boca Raton Clinical Research (BRCR) GlobalRecruiting
Tamarac, Florida, United States
H. Lee Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
University Cancer & Blood CenterRecruiting
Athens, Georgia, United States
John B. Amos Cancer CenterWithdrawn
Columbus, Georgia, United States
Beacon ClinicRecruiting
Coeur d'Alene, Idaho, United States
Hope and Healing Cancer ServicesRecruiting
Hinsdale, Illinois, United States
Advocate Lutheran General HospitalRecruiting
Park Ridge, Illinois, United States
Illinois CancerCareRecruiting
Peoria, Illinois, United States
Fort Wayne Medical Oncology and HematologyRecruiting
Fort Wayne, Indiana, United States
The University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
Markey Cancer Center Clinical Research OrganizationRecruiting
Lexington, Kentucky, United States
Mary Bird Perkins Cancer CenterRecruiting
Baton Rouge, Louisiana, United States
Maryland Oncology Hematology, P.A.Recruiting
Columbia, Maryland, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Henry Ford Cancer Institute/Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Minnesota Oncology Hematology, P.ARecruiting
Fridley, Minnesota, United States
Allina Health Cancer InstituteRecruiting
Minneapolis, Minnesota, United States
VA St. Louis Healthcare SystemRecruiting
St Louis, Missouri, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Mercy SouthRecruiting
St Louis, Missouri, United States
St. Vincent HealthcareRecruiting
Billings, Montana, United States
Oncology Hematology West P.C. dba Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Comprehensive Cancer Centers of NevadaRecruiting
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
John Theurer Cancer CenterRecruiting
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
The Valley Hospital Inc.Recruiting
Paramus, New Jersey, United States
New York Oncology HematologyRecruiting
Albany, New York, United States
Messino Cancer CenterRecruiting
Asheville, North Carolina, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Novant Health Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Novant Health Weisiger Cancer Institute - CharlotteRecruiting
Charlotte, North Carolina, United States
Duke Health SystemRecruiting
Durham, North Carolina, United States
Novant Health Zimmer Cancer Institute - WilmingtonRecruiting
Wilmington, North Carolina, United States
Oncology Hematology Care Clinical TrialsRecruiting
Cincinnati, Ohio, United States
Seidman Cancer CenterRecruiting
Cleveland, Ohio, United States
The Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLCRecruiting
Tulsa, Oklahoma, United States
Oncology Associates of Oregon PCRecruiting
Eugene, Oregon, United States
Kaiser Foundation HospitalsRecruiting
Portland, Oregon, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
St. Luke's University Health NetworkRecruiting
Easton, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Lifespan Cancer InstituteRecruiting
Providence, Rhode Island, United States
Saint Francis Cancer CenterRecruiting
Greenville, South Carolina, United States
Tennessee Oncology - ChattanoogaRecruiting
Chattanooga, Tennessee, United States
University of Tennessee Medical CenterRecruiting
Knoxville, Tennessee, United States
Sarah Cannon Research Institute (SCRI) Oncology PartnersRecruiting
Nashville, Tennessee, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown, Midtown Medical Center IRecruiting
Austin, Texas, United States
Texas Oncology - Austin Central, Central Austin Cancer CenterRecruiting
Austin, Texas, United States
Texas Oncology - BedfordRecruiting
Bedford, Texas, United States
Texas Oncology - Medical CityRecruiting
Dallas, Texas, United States
Texas OncologyRecruiting
Dallas, Texas, United States
Center For Disease And Blood DisorderRecruiting
Fort Worth, Texas, United States
Texas Oncology - Fort WorthRecruiting
Fort Worth, Texas, United States
Texas Oncology - GrapevineRecruiting
Grapevine, Texas, United States
Texas Oncology - Harlingen, Medical Arts PavillionRecruiting
Harlingen, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Oncology - LongviewRecruiting
Longview, Texas, United States
Joe Arrington Cancer Research & Treatment CenterRecruiting
Lubbock, Texas, United States
Texas Oncology - McAllenRecruiting
McAllen, Texas, United States
Texas Oncology-Palestine Cancer CenterRecruiting
Palestine, Texas, United States
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer CenterWithdrawn
Tyler, Texas, United States
Texas Oncology-Tyler, Northeast Texas Cancer InstituteRecruiting
Tyler, Texas, United States
Texas Oncology - Weslaco, Knapp Medical PlazaRecruiting
Weslaco, Texas, United States
University of Utah Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Inova Schar Cancer InstituteRecruiting
Fairfax, Virginia, United States
Virginia Cancer Specialists, PCRecruiting
Fairfax, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Virginia Commonwealth University Massey Cancer CenterRecruiting
Richmond, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.Recruiting
Roanoke, Virginia, United States
Swedish Cancer Institute - Edmonds CampusRecruiting
Edmonds, Washington, United States
Swedish Cancer Institute - Issaquah CampusRecruiting
Issaquah, Washington, United States
Kadlec Clinic Hematology and OncologyRecruiting
Kennewick, Washington, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
West Virginia UniversityRecruiting
Morgantown, West Virginia, United States
University of Wisconsin Carbone Cancer CenterRecruiting
Madison, Wisconsin, United States
London Regional Cancer CentreRecruiting
London, Ontario, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Jewish General Hospital - Main AddressRecruiting
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)Recruiting
Québec, Canada
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) · TrialPath