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NCT06246916PHASE3Recruiting

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)

Regeneron Pharmaceuticals

Start Date

9/9/2024

Completion Date

7/10/2033

Summary

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

fianlimab

DRUG

cemiplimab

DRUG

relatlimab+nivolumab

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Conditions

Melanoma

Locations

Ironwood Cancer & Research Centers

Chandler, Arizona 85224

United States

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

Arizona Oncology Associates

Tucson, Arizona 85711

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

United States

Providence Medical Foundation

Fullerton, California 92835

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

University of California Los Angeles

Los Angeles, California 90024

United States

St. Joseph Hospital Orange

Orange, California 92868

United States

University of California Irvine, UCI Medical Center

Orange, California 92868

United States

Eisenhower Medical Center

Rancho Mirage, California 92270

United States

Emad Ibrahim, MD, Inc.

Redlands, California 92373

United States

Sutter Health

Sacramento, California 95816

United States

University of California San Francisco (UCSF)

San Francisco, California 94143

United States

Sansum Clinic

Santa Barbara, California 93105

United States

St John's Cancer Institute

Santa Monica, California 90404

United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado 80045

United States

University of Colorado Cancer Center

Aurora, Colorado 80045

United States

The Melanoma And Skin Cancer Institute

Englewood, Colorado 80113

United States

UCHealth

Fort Collins, Colorado 80528

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Clermont Oncology Center

Clermont, Florida 34711

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

Cancer Specialist of North Florida

Jacksonville, Florida 32256

United States

Boca Raton Clinical Research (BRCR) Global

Tamarac, Florida 33321

United States

H. Lee Moffitt Cancer Center

Tampa, Florida 33612

United States

University Cancer & Blood Center

Athens, Georgia 30607

United States

John B. Amos Cancer Center

Columbus, Georgia 31904

United States

Beacon Clinic

Coeur d'Alene, Idaho 83815

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois 60068

United States

Illinois CancerCare

Peoria, Illinois 61615

United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana 46825

United States

The University of Kansas Cancer Center

Westwood, Kansas 66205

United States

Markey Cancer Center Clinical Research Organization

Lexington, Kentucky 40536

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana 70809

United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland 21044

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Henry Ford Cancer Institute/Henry Ford Health System

Detroit, Michigan 48202

United States

Minnesota Oncology Hematology, P.A

Fridley, Minnesota 55432

United States

Allina Health Cancer Institute

Minneapolis, Minnesota 55407

United States

VA St. Louis Healthcare System

St Louis, Missouri 63106

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Mercy South

St Louis, Missouri 63128

United States

St. Vincent Healthcare

Billings, Montana 59102

United States

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89148

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

John Theurer Cancer Center

Hackensack, New Jersey 07601

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

The Valley Hospital Inc.

Paramus, New Jersey 07652

United States

New York Oncology Hematology

Albany, New York 12206

United States

Messino Cancer Center

Asheville, North Carolina 28806

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Novant Health Cancer Institute

Charlotte, North Carolina 28204

United States

Novant Health Weisiger Cancer Institute - Charlotte

Charlotte, North Carolina 28204

United States

Duke Health System

Durham, North Carolina 27710

United States

Novant Health Zimmer Cancer Institute - Wilmington

Wilmington, North Carolina 28401

United States

Oncology Hematology Care Clinical Trials

Cincinnati, Ohio 45242

United States

Seidman Cancer Center

Cleveland, Ohio 44106

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma 74146

United States

USOR Willamette Valley Cancer Institute and Research Center

Eugene, Oregon 97401

United States

Kaiser Foundation Hospitals

Portland, Oregon 97227

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

St. Luke's University Health Network

Easton, Pennsylvania 18045

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Lifespan Cancer Institute

Providence, Rhode Island 02903

United States

Saint Francis Cancer Center

Greenville, South Carolina 29607

United States

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee 37404

United States

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Texas Oncology - Austin Midtown, Midtown Medical Center I

Austin, Texas 78705

United States

Texas Oncology - Austin Central, Central Austin Cancer Center

Austin, Texas 78731

United States

Texas Oncology - Bedford

Bedford, Texas 76022

United States

Texas Oncology - Medical City

Dallas, Texas 75230

United States

Texas Oncology

Dallas, Texas 75246

United States

Center For Disease And Blood Disorder

Fort Worth, Texas 76104

United States

Texas Oncology - Fort Worth

Fort Worth, Texas 76104

United States

Texas Oncology - Grapevine

Grapevine, Texas 76051

United States

Texas Oncology - Harlingen, Medical Arts Pavillion

Harlingen, Texas 78550

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Texas Oncology - Longview

Longview, Texas 75601

United States

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas 79410

United States

Texas Oncology - McAllen

McAllen, Texas 78503

United States

Texas Oncology-Palestine Cancer Center

Palestine, Texas 75801

United States

The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center

Tyler, Texas 75701

United States

Texas Oncology-Tyler, Northeast Texas Cancer Institute

Tyler, Texas 75702

United States

Texas Oncology - Weslaco, Knapp Medical Plaza

Weslaco, Texas 78596

United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

University of Virginia

Charlottesville, Virginia 22908

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22031

United States

Virginia Cancer Specialists, PC

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia 23298

United States

Oncology & Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia 24014

United States

Swedish Cancer Institute - Edmonds Campus

Edmonds, Washington 98026

United States

Swedish Cancer Institute - Issaquah Campus

Issaquah, Washington 98029

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington 99336

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

West Virginia University

Morgantown, West Virginia 26506

United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin 53792

United States

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

London Regional Cancer Centre

London, Ontario N6A 5W9

Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Jewish General Hospital - Main Address

Montreal, Quebec H3T 1E2

Canada

Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)

Québec, G1J 0J9

Canada