Recruiting
Phase 3

Anti-LAG-3 & Anti-PD-1

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06246916

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

fianlimab

cemiplimab

relatlimab+nivolumab

Study Details

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

Study ID

NCT06246916

Start date

Sep 9, 2024

Status verified date

Aug, 2026

Completion date

Jul 10, 2033

Anticipated

Primary completion date

Mar 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

560 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: fianlimab+cemiplimab

Randomized 1:1

active comparator: relatlimab+nivolumab

Randomized 1:1

Interventions

fianlimab

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

cemiplimab

IV administration Q3W in combination with fianlimab

relatlimab+nivolumab

IV administration every 4 weeks (Q4W)

Primary outcome measure

  • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR) [ Time Frame: Up to 72 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Ironwood Cancer & Research Centers

Recruiting

Chandler, Arizona, United States, 85224

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90024

St. Joseph Hospital Orange

Recruiting

Orange, California, United States, 92868

University of California Irvine, UCI Medical Center

Recruiting

Orange, California, United States, 92868

Emad Ibrahim, MD, Inc.

Recruiting

Redlands, California, United States, 92373

Sutter Health

Recruiting

Sacramento, California, United States, 95816

University of California San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94143

St John's Cancer Institute

Recruiting

Santa Monica, California, United States, 90404

Rocky Mountain Regional VA Medical Center

Recruiting

Aurora, Colorado, United States, 80045

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

The Melanoma And Skin Cancer Institute

Recruiting

Englewood, Colorado, United States, 80113

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Boca Raton Clinical Research (BRCR) Global

Recruiting

Tamarac, Florida, United States, 33321

H. Lee Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

University Cancer & Blood Center

Recruiting

Athens, Georgia, United States, 30607

Beacon Clinic

Recruiting

Coeur d'Alene, Idaho, United States, 83815

Hope and Healing Cancer Services

Recruiting

Hinsdale, Illinois, United States, 60521

Advocate Lutheran General Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

Illinois CancerCare

Recruiting

Peoria, Illinois, United States, 61615

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46825

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Markey Cancer Center Clinical Research Organization

Recruiting

Lexington, Kentucky, United States, 40536

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Maryland Oncology Hematology, P.A.

Recruiting

Columbia, Maryland, United States, 21044

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Cancer Institute/Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Minnesota Oncology Hematology, P.A

Recruiting

Fridley, Minnesota, United States, 55432

Allina Health Cancer Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

VA St. Louis Healthcare System

Recruiting

St Louis, Missouri, United States, 63106

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Mercy South

Recruiting

St Louis, Missouri, United States, 63128

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89148

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

The Valley Hospital Inc.

Recruiting

Paramus, New Jersey, United States, 07652

New York Oncology Hematology

Recruiting

Albany, New York, United States, 12206

Messino Cancer Center

Recruiting

Asheville, North Carolina, United States, 28806

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Novant Health Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Novant Health Weisiger Cancer Institute - Charlotte

Recruiting

Charlotte, North Carolina, United States, 28204

Duke Health System

Recruiting

Durham, North Carolina, United States, 27710

Novant Health Zimmer Cancer Institute - Wilmington

Recruiting

Wilmington, North Carolina, United States, 28401

Oncology Hematology Care Clinical Trials

Recruiting

Cincinnati, Ohio, United States, 45242

Seidman Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Oklahoma Cancer Specialists and Research Institute, LLC

Recruiting

Tulsa, Oklahoma, United States, 74146

USOR Willamette Valley Cancer Institute and Research Center

Recruiting

Eugene, Oregon, United States, 97401

Kaiser Foundation Hospitals

Recruiting

Portland, Oregon, United States, 97227

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

St. Luke's University Health Network

Recruiting

Easton, Pennsylvania, United States, 18045

Penn State Health Milton South Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Lifespan Cancer Institute

Recruiting

Providence, Rhode Island, United States, 02903

Tennessee Oncology - Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37404

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Sarah Cannon Research Institute (SCRI) Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - Austin Midtown, Midtown Medical Center I

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - Austin Central, Central Austin Cancer Center

Recruiting

Austin, Texas, United States, 78731

Texas Oncology - Bedford

Recruiting

Bedford, Texas, United States, 76022

Texas Oncology - Medical City

Recruiting

Dallas, Texas, United States, 75230

Texas Oncology

Recruiting

Dallas, Texas, United States, 75246

Center For Disease And Blood Disorder

Recruiting

Fort Worth, Texas, United States, 76104

Texas Oncology - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Texas Oncology - Grapevine

Recruiting

Grapevine, Texas, United States, 76051

Texas Oncology - Harlingen, Medical Arts Pavillion

Recruiting

Harlingen, Texas, United States, 78550

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - Longview

Recruiting

Longview, Texas, United States, 75601

Joe Arrington Cancer Research & Treatment Center

Recruiting

Lubbock, Texas, United States, 79410

Texas Oncology - McAllen

Recruiting

McAllen, Texas, United States, 78503

Texas Oncology-Palestine Cancer Center

Recruiting

Palestine, Texas, United States, 75801

Texas Oncology - Weslaco, Knapp Medical Plaza

Recruiting

Weslaco, Texas, United States, 78596

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Commonwealth University Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Oncology & Hematology Associates of Southwest Virginia, Inc.

Recruiting

Roanoke, Virginia, United States, 24014

Swedish Cancer Institute - Edmonds Campus

Recruiting

Edmonds, Washington, United States, 98026

Swedish Cancer Institute - Issaquah Campus

Recruiting

Issaquah, Washington, United States, 98029

Kadlec Clinic Hematology and Oncology

Recruiting

Kennewick, Washington, United States, 99336

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

London Regional Cancer Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Jewish General Hospital - Main Address

Recruiting

Montreal, Quebec, Canada, H3T 1E2

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

Recruiting

Québec, Canada, G1J 0J9

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Unresectable Melanoma
  • Metastatic Melanoma
  • Advanced Melanoma
  • Stage III
  • Stage IV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-19.