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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)

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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)

What is being tested

Sponsor: Regeneron Pharmaceuticals · Participants: 560 · Started: Sep 9, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06246916

Locations in the U.S.

ArizonaIronwood Cancer & Research Centers, Chandler
Banner MD Anderson Cancer Center, Gilbert
ArkansasUniversity of Arkansas for Medical Sciences, Little Rock
CaliforniaProvidence Medical Foundation, Fullerton
Cancer and Blood Specialty Clinic, Los Alamitos
University of California Los Angeles, Los Angeles
St. Joseph Hospital Orange, Orange
University of California Irvine, UCI Medical Center, Orange
Emad Ibrahim, MD, Inc., Redlands
Sutter Health, Sacramento
University of California San Francisco (UCSF), San Francisco
St John's Cancer Institute, Santa Monica
ColoradoRocky Mountain Regional VA Medical Center, Aurora
University of Colorado Cancer Center, Aurora
The Melanoma And Skin Cancer Institute, Englewood
ConnecticutYale Cancer Center, New Haven
FloridaMayo Clinic Florida, Jacksonville
Boca Raton Clinical Research (BRCR) Global, Tamarac
H. Lee Moffitt Cancer Center, Tampa
GeorgiaUniversity Cancer & Blood Center, Athens
IdahoBeacon Clinic, Coeur d'Alene
IllinoisHope and Healing Cancer Services, Hinsdale
Advocate Lutheran General Hospital, Park Ridge
Illinois CancerCare, Peoria
IndianaFort Wayne Medical Oncology and Hematology, Fort Wayne
KansasThe University of Kansas Cancer Center, Westwood
KentuckyMarkey Cancer Center Clinical Research Organization, Lexington
LouisianaMary Bird Perkins Cancer Center, Baton Rouge
MarylandMaryland Oncology Hematology, P.A., Columbia
MichiganUniversity of Michigan, Ann Arbor
Henry Ford Cancer Institute/Henry Ford Health System, Detroit
MinnesotaMinnesota Oncology Hematology, P.A, Fridley
Allina Health Cancer Institute, Minneapolis
MissouriMercy South, St Louis
VA St. Louis Healthcare System, St Louis
Washington University School of Medicine, St Louis
NebraskaOncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha
NevadaComprehensive Cancer Centers of Nevada, Las Vegas
New HampshireDartmouth Hitchcock Medical Center, Lebanon
New JerseyJohn Theurer Cancer Center, Hackensack
Rutgers Cancer Institute of New Jersey, New Brunswick
The Valley Hospital Inc., Paramus
New YorkNew York Oncology Hematology, Albany
North CarolinaMessino Cancer Center, Asheville
Levine Cancer Institute, Charlotte
Novant Health Cancer Institute, Charlotte
Novant Health Weisiger Cancer Institute - Charlotte, Charlotte
Duke Health System, Durham
Novant Health Zimmer Cancer Institute - Wilmington, Wilmington
OhioOncology Hematology Care Clinical Trials, Cincinnati
Seidman Cancer Center, Cleveland
The Ohio State University Wexner Medical Center, Columbus
OklahomaOklahoma Cancer Specialists and Research Institute, LLC, Tulsa
OregonUSOR Willamette Valley Cancer Institute and Research Center, Eugene
Kaiser Foundation Hospitals, Portland
Oregon Health and Science University, Portland
PennsylvaniaSt. Luke's University Health Network, Easton
Penn State Health Milton South Hershey Medical Center, Hershey
Fox Chase Cancer Center, Philadelphia
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, Pittsburgh
Rhode IslandLifespan Cancer Institute, Providence
TennesseeTennessee Oncology - Chattanooga, Chattanooga
University of Tennessee Medical Center, Knoxville
Sarah Cannon Research Institute (SCRI) Oncology Partners, Nashville
Tennessee Oncology, Nashville
TexasTexas Oncology - Austin Central, Central Austin Cancer Center, Austin
Texas Oncology - Austin Midtown, Midtown Medical Center I, Austin
Texas Oncology - South Austin, South Austin Cancer Center, Austin
Texas Oncology - Bedford, Bedford
Texas Oncology, Dallas
Texas Oncology - Medical City, Dallas
Center For Disease And Blood Disorder, Fort Worth
Texas Oncology - Fort Worth, Fort Worth
Texas Oncology - Grapevine, Grapevine
Texas Oncology - Harlingen, Medical Arts Pavillion, Harlingen
The University of Texas MD Anderson Cancer Center, Houston
Texas Oncology - Longview, Longview
Joe Arrington Cancer Research & Treatment Center, Lubbock
Texas Oncology - McAllen, McAllen
Texas Oncology-Palestine Cancer Center, Palestine
Texas Oncology - Weslaco, Knapp Medical Plaza, Weslaco
UtahUniversity of Utah Huntsman Cancer Institute, Salt Lake City
VirginiaUniversity of Virginia, Charlottesville
Inova Schar Cancer Institute, Fairfax
Virginia Commonwealth University Massey Cancer Center, Richmond
Oncology & Hematology Associates of Southwest Virginia, Inc., Roanoke
WashingtonSwedish Cancer Institute - Edmonds Campus, Edmonds
Swedish Cancer Institute - Issaquah Campus, Issaquah
Kadlec Clinic Hematology and Oncology, Kennewick
Swedish Cancer Institute, Seattle
West VirginiaWest Virginia University, Morgantown
WisconsinUniversity of Wisconsin Carbone Cancer Center, Madison

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.