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)

Last updated: May 8, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Melanoma

Treatment

cemiplimab

relatlimab+nivolumab

fianlimab

Clinical Study ID

NCT06246916
R3767-ONC-22122
  • Ages > 18
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria:

  1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revisededition.

  2. Participants must not have received prior systemic therapy for unresectable ormetastatic 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 orsubmitted sample for BRAF V600 mutation assessment as described in the protocol

Exclusion

Key Exclusion Criteria:

Medical Conditions:

  1. Uveal, acral or mucosal melanoma.

  2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that requiredsystemic 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 isrelated to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic orrecurrent infection) is allowed. Prior/Concomitant Therapy:

  4. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described inthe 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 theprotocol.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Study Design

Total Participants: 560
Treatment Group(s): 3
Primary Treatment: cemiplimab
Phase: 3
Study Start date:
September 09, 2024
Estimated Completion Date:
July 10, 2033

Connect with a study center

  • London Regional Cancer Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

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

    Quebec, G1G 5X1
    Canada

    Active - Recruiting

  • Ironwood Cancer & Research Centers

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Arizona Oncology Associates

    Tucson, Arizona 85711
    United States

    Active - Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Eisenhower Medical Center

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

  • Sutter Health

    Sacramento, California 95816
    United States

    Active - Recruiting

  • UCSF

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Sansum Clinic

    Santa Barbara, California 93105
    United States

    Active - Recruiting

  • St John's Cancer Institute

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • The Melanoma And Skin Cancer Institute

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • UCHealth

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Clermont Oncology Center

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Cancer Specialist of North Florida

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Boca Raton Clinical Research (BRCR) Global

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • H. Lee Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • John B. Amos Cancer Center

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Beacon Clinic

    Coeur d'Alene, Idaho 83815
    United States

    Active - Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois 60068
    United States

    Active - Recruiting

  • Illinois CancerCare

    Peoria, Illinois 61615
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46825-1623
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Markey Cancer Center Clinical Research Organization

    Lexington, Kentucky 40536-0093
    United States

    Active - Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A

    Fridley, Minnesota 55424
    United States

    Active - Recruiting

  • Allina Health Cancer Institute

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Mercy South

    Saint Louis, Missouri 63128
    United States

    Active - Recruiting

  • VA St. Louis Healthcare System

    Saint Louis, Missouri 63106
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • St. Vincent Healthcare

    Billings, Montana 59102
    United States

    Active - Recruiting

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Oncology Hematology West, P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Regeneron Study Facility

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada - Southwest

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

  • New York Oncology Hematology

    Albany, New York 12206
    United States

    Active - Recruiting

  • Messino Cancer Center

    Asheville, North Carolina 28806
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Oncology Hematology Care Clinical Trials

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Seidman Cancer Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

  • Kaiser Foundation Hospitals

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • St. Luke's University Health Network

    Easton, Pennsylvania 18045
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Lifespan Cancer Institute

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Saint Francis Cancer Center

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

  • Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology - Austin Central, Central Austin Cancer Center

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Center For Disease And Blood Disorder

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • Texas Oncology-Tyler, Northeast Texas Cancer Institute

    Tyler, Texas 75702
    United States

    Active - Recruiting

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

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Oncology & Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Swedish Cancer Institute - Edmonds Campus

    Edmonds, Washington 98026
    United States

    Active - Recruiting

  • Swedish Cancer Institute - Issaquah Campus

    Issaquah, Washington 98029
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104-3551
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • West Virginia University (Please Use)

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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