A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Regeneron Pharmaceuticals (industry)

Phase: 3

Start date: Sept. 9, 2024

Planned enrollment: 560

Trial ID: NCT06246916
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More trial details at ClinicalTrials.gov More info

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chevron Show for: fianlimab (REGN3767)

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Goal: Compare the antitumor activity and safety of fianlimab plus cemiplimab with relatlimab plus nivolumab in unresectable or metastatic melanoma.

Patients: Participants with histologically confirmed unresectable stage III or stage IV melanoma, measurable disease, ECOG performance status 0–1, and no prior systemic therapy for unresectable or metastatic disease. BRAF V600 status must be known or assessed. Key exclusions include uveal, acral, or mucosal melanoma; active or untreated brain metastases; clinically significant autoimmune disease requiring systemic immunosuppression; and a history of myocarditis.

Design: Randomized, 1:1, active-comparator trial with follow-up for outcomes up to 72 months.

Treatments: Participants receive either the fixed-dose combination of fianlimab and cemiplimab or relatlimab plus nivolumab. Fianlimab is an investigational anti–LAG-3 antibody that blocks inhibitory LAG-3 signaling on T cells; cemiplimab blocks PD-1. In a single-arm phase 1 melanoma cohort without prior anti–PD-1 therapy for advanced disease, the combination produced a 61.2% investigator-assessed response rate, but a separate phase 3 comparison against pembrolizumab did not significantly improve progression-free survival. Relatlimab plus nivolumab is an approved LAG-3/PD-1 checkpoint-inhibitor combination for melanoma.

Outcomes: The primary endpoint is objective response rate by blinded independent central review using RECIST 1.1. Secondary measures include progression-free and overall survival, duration of response, disease control, investigator-assessed tumor outcomes, adverse events and laboratory abnormalities, serum drug concentrations, and anti-drug and neutralizing antibodies.

Burden on patient: Moderate. Treatment and serial tumor assessments are broadly consistent with care for advanced melanoma, but trial participation adds scheduled safety monitoring and blood draws for pharmacokinetics and immunogenicity. Visits and follow-up may continue for an extended period; the supplied information does not specify dosing or scan frequency or require research biopsies.

Last updated: Sep 2026

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

Québec, G1J 0J9, Canada

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Status: Recruiting

London Regional Cancer Centre

London, Ontario, N6A 5W9, Canada

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Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

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Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

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Jewish General Hospital - Main Address

Montreal, Quebec, H3T 1E2, Canada

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Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

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Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

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Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

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Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

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Emad Ibrahim, MD, Inc.

Redlands, California, 92373, United States

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Providence Medical Foundation

Fullerton, California, 92835, United States

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Sansum Clinic

Santa Barbara, California, 93105, United States

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St John's Cancer Institute

Santa Monica, California, 90404, United States

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St. Joseph Hospital Orange

Orange, California, 92868, United States

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Sutter Health

Sacramento, California, 95816, United States

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University of California Los Angeles

Los Angeles, California, 90024, United States

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University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

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Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

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The Melanoma And Skin Cancer Institute

Englewood, Colorado, 80113, United States

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UCHealth

Fort Collins, Colorado, 80528, United States

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University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

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Yale Cancer Center

New Haven, Connecticut, 06510, United States

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Boca Raton Clinical Research (BRCR) Global

Tamarac, Florida, 33321, United States

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Cancer Specialist of North Florida

Jacksonville, Florida, 32256, United States

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Clermont Oncology Center

Clermont, Florida, 34711, United States

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H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

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Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

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University Cancer & Blood Center

Athens, Georgia, 30607, United States

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Beacon Clinic

Coeur d'Alene, Idaho, 83815, United States

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Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

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Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

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Illinois CancerCare

Peoria, Illinois, 61615, United States

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Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46825, United States

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The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

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Markey Cancer Center Clinical Research Organization

Lexington, Kentucky, 40536, United States

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Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

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Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

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Henry Ford Cancer Institute/Henry Ford Health System

Detroit, Michigan, 48202, United States

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Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

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University of Michigan

Ann Arbor, Michigan, 48109, United States

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Allina Health Cancer Institute

Minneapolis, Minnesota, 55407, United States

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Minnesota Oncology Hematology, P.A

Fridley, Minnesota, 55432, United States

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Mercy South

St Louis, Missouri, 63128, United States

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VA St. Louis Healthcare System

St Louis, Missouri, 63106, United States

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Washington University

St Louis, Missouri, 63110, United States

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St. Vincent Healthcare

Billings, Montana, 59102, United States

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Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

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Status: Recruiting

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

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Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

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John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

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Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

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The Valley Hospital Inc.

Paramus, New Jersey, 07652, United States

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New York Oncology Hematology

Albany, New York, 12206, United States

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Status: Recruiting

Duke Health System

Durham, North Carolina, 27710, United States

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Status: Recruiting

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

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Messino Cancer Center

Asheville, North Carolina, 28806, United States

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Novant Health Cancer Institute

Charlotte, North Carolina, 28204, United States

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Novant Health Weisiger Cancer Institute - Charlotte

Charlotte, North Carolina, 28204, United States

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Novant Health Zimmer Cancer Institute - Wilmington

Wilmington, North Carolina, 28401, United States

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Oncology Hematology Care Clinical Trials

Cincinnati, Ohio, 45242, United States

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Seidman Cancer Center

Cleveland, Ohio, 44106, United States

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The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

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Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

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Kaiser Foundation Hospitals

Portland, Oregon, 97227, United States

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Oncology Associates of Oregon PC

Eugene, Oregon, 97401, United States

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Oregon Health and Science University

Portland, Oregon, 97239, United States

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

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St. Luke's University Health Network

Easton, Pennsylvania, 18045, United States

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University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

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Lifespan Cancer Institute

Providence, Rhode Island, 02903, United States

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Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

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Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, 37203, United States

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Status: Recruiting

Tennessee Oncology

Nashville, Tennessee, 37203, United States

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Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, 37404, United States

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University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

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Center For Disease And Blood Disorder

Fort Worth, Texas, 76104, United States

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Status: Recruiting

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, 79410, United States

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Status: Recruiting

Texas Oncology

Dallas, Texas, 75246, United States

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Status: Recruiting

Texas Oncology - Austin Central, Central Austin Cancer Center

Austin, Texas, 78731, United States

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Status: Recruiting

Texas Oncology - Austin Midtown, Midtown Medical Center I

Austin, Texas, 78705, United States

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Texas Oncology - Bedford

Bedford, Texas, 76022, United States

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Texas Oncology - Fort Worth

Fort Worth, Texas, 76104, United States

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Texas Oncology - Grapevine

Grapevine, Texas, 76051, United States

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Texas Oncology - Harlingen, Medical Arts Pavillion

Harlingen, Texas, 78550, United States

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Texas Oncology - Longview

Longview, Texas, 75601, United States

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Texas Oncology - McAllen

McAllen, Texas, 78503, United States

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Status: Recruiting

Texas Oncology - Medical City

Dallas, Texas, 75230, United States

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Status: Recruiting

Texas Oncology - Weslaco, Knapp Medical Plaza

Weslaco, Texas, 78596, United States

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Status: Recruiting

Texas Oncology-Palestine Cancer Center

Palestine, Texas, 75801, United States

No email / No phone

Status: Recruiting

Texas Oncology-Tyler, Northeast Texas Cancer Institute

Tyler, Texas, 75702, United States

No email / No phone

Status: Recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

No email / No phone

Status: Recruiting

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

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Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

No email / No phone

Status: Recruiting

University of Virginia

Charlottesville, Virginia, 22908, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Recruiting

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

No email / No phone

Status: Recruiting

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

No email / No phone

Status: Recruiting

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

No email / No phone

Status: Recruiting

Swedish Cancer Institute

Seattle, Washington, 98104, United States

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Status: Recruiting

Swedish Cancer Institute - Edmonds Campus

Edmonds, Washington, 98026, United States

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Status: Recruiting

Swedish Cancer Institute - Issaquah Campus

Issaquah, Washington, 98029, United States

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Status: Recruiting

West Virginia University

Morgantown, West Virginia, 26506, United States

No email / No phone

Status: Recruiting

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

No email / No phone

Status: Recruiting

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

No email / No phone

Status: Withdrawn

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

No email / No phone

Status: Withdrawn

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

Tyler, Texas, 75701, United States

No email / No phone

Status: Withdrawn

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