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 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: R3767-ONC-22122
• Study Type: interventional
• Target: 560
• Locations: 2 countries
• Sites: 109

Brief 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)

Conditions

Melanoma

Keywords

Unresectable Melanoma; Metastatic Melanoma; Advanced Melanoma; Stage III; Stage IV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (24)

• Progression free survival (PFS) RECIST version 1.1 based on BICR

  Up to 72 months

• Death from any cause

  Up to 72 months

• Overall survival (OS)

  Up to 72 months

• Duration of Response (DOR) by BICR

  Up to 72 months

• DOR by investigator assessment

  Up to 72 months

Study Arms (2)

fianlimab+cemiplimab

EXPERIMENTAL

Randomized 1:1

Drug: fianlimab; Drug: cemiplimab

relatlimab+nivolumab

ACTIVE COMPARATOR

Randomized 1:1

Drug: relatlimab+nivolumab

Interventions

cemiplimab DRUG

IV administration Q3W in combination with fianlimab

Also known as: REGN2810, LIBTAYO®

fianlimab+cemiplimab

relatlimab+nivolumab DRUG

IV administration every 4 weeks (Q4W)

Also known as: Opdualag™

relatlimab+nivolumab

fianlimab DRUG

Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab

Also known as: REGN3767

fianlimab+cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
• Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
• Measurable disease per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate bone marrow, hepatic, and kidney function
• Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol

You may not qualify if:

• Medical Conditions:
• Uveal, acral or mucosal melanoma.
• Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
• 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:
• Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
• Systemic immune suppression as described in the protocol.
• Other Comorbidities:
• Participants with a history of myocarditis.
• Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
• Active or untreated brain metastases or spinal cord compression as described in the protocol.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (109)

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

WITHDRAWN

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Providence Medical Foundation

Fullerton, California, 92835, United States

RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90024, United States

RECRUITING

St. Joseph Hospital Orange

Orange, California, 92868, United States

RECRUITING

University of California Irvine, UCI Medical Center

Orange, California, 92868, United States

RECRUITING

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

WITHDRAWN

Emad Ibrahim, MD, Inc.

Redlands, California, 92373, United States

RECRUITING

Sutter Health

Sacramento, California, 95816, United States

RECRUITING

University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

RECRUITING

Sansum Clinic

Santa Barbara, California, 93105, United States

RECRUITING

St John's Cancer Institute

Santa Monica, California, 90404, United States

RECRUITING

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

The Melanoma And Skin Cancer Institute

Englewood, Colorado, 80113, United States

RECRUITING

UCHealth

Fort Collins, Colorado, 80528, United States

WITHDRAWN

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Clermont Oncology Center

Clermont, Florida, 34711, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Cancer Specialist of North Florida

Jacksonville, Florida, 32256, United States

RECRUITING

Boca Raton Clinical Research (BRCR) Global

Tamarac, Florida, 33321, United States

RECRUITING

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University Cancer & Blood Center

Athens, Georgia, 30607, United States

RECRUITING

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

WITHDRAWN

Beacon Clinic

Coeur d'Alene, Idaho, 83815, United States

RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

RECRUITING

Illinois CancerCare

Peoria, Illinois, 61615, United States

RECRUITING

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46825, United States

RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Markey Cancer Center Clinical Research Organization

Lexington, Kentucky, 40536, United States

RECRUITING

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

WITHDRAWN

Henry Ford Cancer Institute/Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Minnesota Oncology Hematology, P.A

Fridley, Minnesota, 55432, United States

RECRUITING

Allina Health Cancer Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

VA St. Louis Healthcare System

St Louis, Missouri, 63106, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Mercy South

St Louis, Missouri, 63128, United States

RECRUITING

St. Vincent Healthcare

Billings, Montana, 59102, United States

RECRUITING

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

The Valley Hospital Inc.

Paramus, New Jersey, 07652, United States

RECRUITING

New York Oncology Hematology

Albany, New York, 12206, United States

RECRUITING

Messino Cancer Center

Asheville, North Carolina, 28806, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Novant Health Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Novant Health Weisiger Cancer Institute - Charlotte

Charlotte, North Carolina, 28204, United States

RECRUITING

Duke Health System

Durham, North Carolina, 27710, United States

RECRUITING

Novant Health Zimmer Cancer Institute - Wilmington

Wilmington, North Carolina, 28401, United States

RECRUITING

Oncology Hematology Care Clinical Trials

Cincinnati, Ohio, 45242, United States

RECRUITING

Seidman Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

RECRUITING

Oncology Associates of Oregon PC

Eugene, Oregon, 97401, United States

RECRUITING

Kaiser Foundation Hospitals

Portland, Oregon, 97227, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

St. Luke's University Health Network

Easton, Pennsylvania, 18045, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Lifespan Cancer Institute

Providence, Rhode Island, 02903, United States

RECRUITING

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

WITHDRAWN

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, 37404, United States

RECRUITING

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Austin Midtown, Midtown Medical Center I

Austin, Texas, 78705, United States

RECRUITING

Texas Oncology - Austin Central, Central Austin Cancer Center

Austin, Texas, 78731, United States

RECRUITING

Texas Oncology - Bedford

Bedford, Texas, 76022, United States

RECRUITING

Texas Oncology - Medical City

Dallas, Texas, 75230, United States

RECRUITING

Texas Oncology

Dallas, Texas, 75246, United States

RECRUITING

Center For Disease And Blood Disorder

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Oncology - Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Oncology - Grapevine

Grapevine, Texas, 76051, United States

RECRUITING

Texas Oncology - Harlingen, Medical Arts Pavillion

Harlingen, Texas, 78550, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - Longview

Longview, Texas, 75601, United States

RECRUITING

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, 79410, United States

RECRUITING

Texas Oncology - McAllen

McAllen, Texas, 78503, United States

RECRUITING

Texas Oncology-Palestine Cancer Center

Palestine, Texas, 75801, United States

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

WITHDRAWN

Texas Oncology-Tyler, Northeast Texas Cancer Institute

Tyler, Texas, 75702, United States

RECRUITING

Texas Oncology - Weslaco, Knapp Medical Plaza

Weslaco, Texas, 78596, United States

RECRUITING

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

RECRUITING

Swedish Cancer Institute - Edmonds Campus

Edmonds, Washington, 98026, United States

RECRUITING

Swedish Cancer Institute - Issaquah Campus

Issaquah, Washington, 98029, United States

RECRUITING

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

London Regional Cancer Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Jewish General Hospital - Main Address

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

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

Québec, G1J 0J9, Canada

RECRUITING

Related Links

• Study Informational Website

MeSH Terms

Conditions

Melanoma

Interventions

cemiplimab; Opdualag

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): July 10, 2033
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf.

Locations

US (104); CA (5)