Purpose

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)

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
fianlimab+cemiplimab
Randomized 1:1
  • Drug: fianlimab
    Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
    Other names:
    • REGN3767
  • Drug: cemiplimab
    IV administration Q3W in combination with fianlimab
    Other names:
    • REGN2810
    • LIBTAYO®
Active Comparator
relatlimab+nivolumab
Randomized 1:1
  • Drug: relatlimab+nivolumab
    IV administration every 4 weeks (Q4W)
    Other names:
    • Opdualag™

Recruiting Locations

Ironwood Cancer & Research Centers
Chandler 5289282, Arizona 5551752 85224

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234

Arizona Oncology Associates
Tucson 5318313, Arizona 5551752 85711

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205

Providence Medical Foundation
Fullerton 5351247, California 5332921 92835

Cancer and Blood Specialty Clinic
Los Alamitos 5368304, California 5332921 90720

University of California Los Angeles
Los Angeles 5368361, California 5332921 90095

St. Joseph Hospital Orange
Orange 5379513, California 5332921 92868

Eisenhower Medical Center
Rancho Mirage 5386015, California 5332921 92270

Sutter Health
Sacramento 5389489, California 5332921 95816

University of California San Francisco (UCSF)
San Francisco 5391959, California 5332921 94143

Sansum Clinic
Santa Barbara 5392952, California 5332921 93105

St John's Cancer Institute
Santa Monica 5393212, California 5332921 90404

Rocky Mountain Regional VA Medical Center
Aurora 5412347, Colorado 5417618 80045

University of Colorado Cancer Center
Aurora 5412347, Colorado 5417618 80045

The Melanoma And Skin Cancer Institute
Englewood 5421250, Colorado 5417618 80113

UCHealth
Fort Collins 5577147, Colorado 5417618 80528

Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510

Clermont Oncology Center
Clermont 4151352, Florida 4155751 34711

Mayo Clinic Florida
Jacksonville 4160021, Florida 4155751 32224

Cancer Specialist of North Florida
Jacksonville 4160021, Florida 4155751 32256

Boca Raton Clinical Research (BRCR) Global
Tamarac 4174738, Florida 4155751 33321

H. Lee Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612

University Cancer & Blood Center
Athens 4180386, Georgia 4197000 30607

John B. Amos Cancer Center
Columbus 4188985, Georgia 4197000 31904

Beacon Clinic
Coeur d'Alene 5589173, Idaho 5596512 83815

Hope and Healing Cancer Services
Hinsdale 4896012, Illinois 4896861 60521

Advocate Lutheran General Hospital
Park Ridge 4905367, Illinois 4896861 60068

Illinois CancerCare
Peoria 4905687, Illinois 4896861 61615

Fort Wayne Medical Oncology and Hematology
Fort Wayne 4920423, Indiana 4921868 46825-1623

The University of Kansas Cancer Center
Westwood 4281639, Kansas 4273857 66205

Markey Cancer Center Clinical Research Organization
Lexington 4297983, Kentucky 6254925 40536-0093

Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987 70809

Maryland Oncology Hematology, P.A.
Columbia 4352053, Maryland 4361885 21044

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201

Minnesota Oncology Hematology, P.A
Fridley 5027482, Minnesota 5037779 55432

Allina Health Cancer Institute
Minneapolis 5037649, Minnesota 5037779 55407

VA St. Louis Healthcare System
St Louis 4407066, Missouri 4398678 63106

Washington University
St Louis 4407066, Missouri 4398678 63110

Mercy South
St Louis 4407066, Missouri 4398678 63128

St. Vincent Healthcare
Billings 5640350, Montana 5667009 59102

Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708 68130

Comprehensive Cancer Centers of Nevada
Las Vegas 5506956, Nevada 5509151 89148

John Theurer Cancer Center
Hackensack 5098706, New Jersey 5101760 07601

Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901

The Valley Hospital Inc.
Paramus 5102387, New Jersey 5101760 07652

New York Oncology Hematology
Albany 5106834, New York 5128638 12206

Messino Cancer Center
Asheville 4453066, North Carolina 4482348 28806

Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204

Novant Health Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204

Novant Health Weisiger Cancer Institute - Charlotte
Charlotte 4460243, North Carolina 4482348 28204

Duke Health System
Durham 4464368, North Carolina 4482348 27710

Novant Health Zimmer Cancer Institute - Wilmington
Wilmington 4499379, North Carolina 4482348 28401

Oncology Hematology Care Clinical Trials
Cincinnati 4508722, Ohio 5165418 45242

Seidman Cancer Center
Cleveland 5150529, Ohio 5165418 44106

Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa 4553433, Oklahoma 4544379 74146

Oncology Associates of Oregon PC
Eugene 5725846, Oregon 5744337 97401

Kaiser Foundation Hospitals
Portland 5746545, Oregon 5744337 97227

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239

St. Luke's University Health Network
Easton 5188140, Pennsylvania 6254927 18045

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232

Lifespan Cancer Institute
Providence 5224151, Rhode Island 5224323 02903

Saint Francis Cancer Center
Greenville 4580543, South Carolina 4597040 29607

Tennessee Oncology - Chattanooga
Chattanooga 4612862, Tennessee 4662168 37404

University of Tennessee Medical Center
Knoxville 4634946, Tennessee 4662168 37920

Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203

Texas Oncology - Austin Midtown, Midtown Medical Center I
Austin 4671654, Texas 4736286 78705

Texas Oncology - Austin Central, Central Austin Cancer Center
Austin 4671654, Texas 4736286 78731

Texas Oncology - Bedford
Bedford 4673094, Texas 4736286 76022

Texas Oncology - Medical City
Dallas 4684888, Texas 4736286 75230

Texas Oncology
Dallas 4684888, Texas 4736286 75246

Center For Disease And Blood Disorder
Fort Worth 4691930, Texas 4736286 76104

Texas Oncology - Fort Worth
Fort Worth 4691930, Texas 4736286 76104

Texas Oncology - Grapevine
Grapevine 4694568, Texas 4736286 76051

Texas Oncology - Harlingen, Medical Arts Pavillion
Harlingen 4696233, Texas 4736286 78550

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Texas Oncology - Longview
Longview 4707814, Texas 4736286 75601

Joe Arrington Cancer Research & Treatment Center
Lubbock 5525577, Texas 4736286 79410

Texas Oncology - McAllen
McAllen 4709796, Texas 4736286 78503

Texas Oncology-Palestine Cancer Center
Palestine 4717232, Texas 4736286 75801

The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
Tyler 4738214, Texas 4736286 75701

Texas Oncology-Tyler, Northeast Texas Cancer Institute
Tyler 4738214, Texas 4736286 75702

Texas Oncology - Weslaco, Knapp Medical Plaza
Weslaco 4740629, Texas 4736286 78596

University of Utah Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112

University of Virginia
Charlottesville 4752031, Virginia 6254928 22908

Virginia Cancer Specialists, PC
Fairfax 4758023, Virginia 6254928 22031

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502

Virginia Commonwealth University Massey Cancer Center
Richmond 4781708, Virginia 6254928 23298

Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke 4782167, Virginia 6254928 24014

Swedish Cancer Institute - Edmonds Campus
Edmonds 5793427, Washington 5815135 98026

Swedish Cancer Institute - Issaquah Campus
Issaquah 5798487, Washington 5815135 98029

Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104-3551

West Virginia University
Morgantown 4815352, West Virginia 4826850 26506

University of Wisconsin Carbone Cancer Center
Madison 5261457, Wisconsin 5279468 53792

More Details

NCT ID
NCT06246916
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.