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)

ClinicalTrials.gov ID: NCT06246916

Public ClinicalTrials.gov record NCT06246916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 11:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID: NCT06246916
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Regeneron Pharmaceuticals; Industry
Enrollment: 560 participants

Conditions and interventions

Conditions

Melanoma

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 8, 2024
Primary completion: Mar 21, 2027
Completion: Jul 9, 2033
Last update posted: Aug 18, 2026

2024 – 2033

United States locations

U.S. sites: 105
U.S. states: 37
U.S. cities: 90

Facility	City	State	ZIP	Site status
Ironwood Cancer & Research Centers	Chandler	Arizona	85224	Recruiting
Banner MD Anderson Cancer Center	Gilbert	Arizona	85234	Recruiting
Arizona Oncology Associates	Tucson	Arizona	85711	Withdrawn
University of Arkansas for Medical Sciences	Little Rock	Arkansas	72205	Recruiting
Providence Medical Foundation	Fullerton	California	92835	Recruiting
Cancer and Blood Specialty Clinic	Los Alamitos	California	90720	Recruiting
University of California Los Angeles	Los Angeles	California	90024	Recruiting
St. Joseph Hospital Orange	Orange	California	92868	Recruiting
University of California Irvine, UCI Medical Center	Orange	California	92868	Recruiting
Eisenhower Medical Center	Rancho Mirage	California	92270	Withdrawn
Emad Ibrahim, MD, Inc.	Redlands	California	92373	Recruiting
Sutter Health	Sacramento	California	95816	Recruiting
University of California San Francisco (UCSF)	San Francisco	California	94143	Recruiting
Sansum Clinic	Santa Barbara	California	93105	Withdrawn
St John's Cancer Institute	Santa Monica	California	90404	Recruiting
Rocky Mountain Regional VA Medical Center	Aurora	Colorado	80045	Recruiting
University of Colorado Cancer Center	Aurora	Colorado	80045	Recruiting
The Melanoma And Skin Cancer Institute	Englewood	Colorado	80113	Recruiting
UCHealth	Fort Collins	Colorado	80528	Withdrawn
Yale Cancer Center	New Haven	Connecticut	06510	Recruiting
Clermont Oncology Center	Clermont	Florida	34711	Withdrawn
Mayo Clinic Florida	Jacksonville	Florida	32224	Recruiting
Cancer Specialist of North Florida	Jacksonville	Florida	32256	Withdrawn
Boca Raton Clinical Research (BRCR) Global	Tamarac	Florida	33321	Recruiting
H. Lee Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
University Cancer & Blood Center	Athens	Georgia	30607	Recruiting
John B. Amos Cancer Center	Columbus	Georgia	31904	Withdrawn
Beacon Clinic	Coeur d'Alene	Idaho	83815	Recruiting
Hope and Healing Cancer Services	Hinsdale	Illinois	60521	Recruiting
Advocate Lutheran General Hospital	Park Ridge	Illinois	60068	Recruiting
Illinois CancerCare	Peoria	Illinois	61615	Recruiting
Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	46825	Recruiting
The University of Kansas Cancer Center	Westwood	Kansas	66205	Recruiting
Markey Cancer Center Clinical Research Organization	Lexington	Kentucky	40536	Recruiting
Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	70809	Recruiting
Maryland Oncology Hematology, P.A.	Columbia	Maryland	21044	Recruiting
University of Michigan	Ann Arbor	Michigan	48109	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	48201	Withdrawn
Henry Ford Cancer Institute/Henry Ford Health System	Detroit	Michigan	48202	Recruiting
Minnesota Oncology Hematology, P.A	Fridley	Minnesota	55432	Recruiting
Allina Health Cancer Institute	Minneapolis	Minnesota	55407	Recruiting
VA St. Louis Healthcare System	St Louis	Missouri	63106	Recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Recruiting
Mercy South	St Louis	Missouri	63128	Recruiting
St. Vincent Healthcare	Billings	Montana	59102	Withdrawn
Oncology Hematology West P.C. dba Nebraska Cancer Specialists	Omaha	Nebraska	68130	Recruiting
Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	89148	Recruiting
Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	03756	Recruiting
John Theurer Cancer Center	Hackensack	New Jersey	07601	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	08901	Recruiting
The Valley Hospital Inc.	Paramus	New Jersey	07652	Recruiting
New York Oncology Hematology	Albany	New York	12206	Recruiting
Messino Cancer Center	Asheville	North Carolina	28806	Recruiting
Levine Cancer Institute	Charlotte	North Carolina	28204	Recruiting
Novant Health Cancer Institute	Charlotte	North Carolina	28204	Recruiting
Novant Health Weisiger Cancer Institute - Charlotte	Charlotte	North Carolina	28204	Recruiting
Duke Health System	Durham	North Carolina	27710	Recruiting
Novant Health Zimmer Cancer Institute - Wilmington	Wilmington	North Carolina	28401	Recruiting
Oncology Hematology Care Clinical Trials	Cincinnati	Ohio	45242	Recruiting
Seidman Cancer Center	Cleveland	Ohio	44106	Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	43210	Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC	Tulsa	Oklahoma	74146	Recruiting
USOR Willamette Valley Cancer Institute and Research Center	Eugene	Oregon	97401	Recruiting
Kaiser Foundation Hospitals	Portland	Oregon	97227	Recruiting
Oregon Health and Science University	Portland	Oregon	97239	Recruiting
St. Luke's University Health Network	Easton	Pennsylvania	18045	Recruiting
Penn State Health Milton South Hershey Medical Center	Hershey	Pennsylvania	17033	Recruiting
Fox Chase Cancer Center	Philadelphia	Pennsylvania	19111	Recruiting
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Recruiting
Lifespan Cancer Institute	Providence	Rhode Island	02903	Recruiting
Saint Francis Cancer Center	Greenville	South Carolina	29607	Withdrawn
Tennessee Oncology - Chattanooga	Chattanooga	Tennessee	37404	Recruiting
University of Tennessee Medical Center	Knoxville	Tennessee	37920	Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners	Nashville	Tennessee	37203	Recruiting
Tennessee Oncology	Nashville	Tennessee	37203	Recruiting
Texas Oncology - Austin Midtown, Midtown Medical Center I	Austin	Texas	78705	Recruiting
Texas Oncology - Austin Central, Central Austin Cancer Center	Austin	Texas	78731	Recruiting
Texas Oncology - Bedford	Bedford	Texas	76022	Recruiting
Texas Oncology - Medical City	Dallas	Texas	75230	Recruiting
Texas Oncology	Dallas	Texas	75246	Recruiting
Center For Disease And Blood Disorder	Fort Worth	Texas	76104	Recruiting
Texas Oncology - Fort Worth	Fort Worth	Texas	76104	Recruiting
Texas Oncology - Grapevine	Grapevine	Texas	76051	Recruiting
Texas Oncology - Harlingen, Medical Arts Pavillion	Harlingen	Texas	78550	Recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
Texas Oncology - Longview	Longview	Texas	75601	Recruiting
Joe Arrington Cancer Research & Treatment Center	Lubbock	Texas	79410	Recruiting
Texas Oncology - McAllen	McAllen	Texas	78503	Recruiting
Texas Oncology-Palestine Cancer Center	Palestine	Texas	75801	Recruiting
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center	Tyler	Texas	75701	Withdrawn
Texas Oncology-Tyler, Northeast Texas Cancer Institute	Tyler	Texas	75702	Withdrawn
Texas Oncology - Weslaco, Knapp Medical Plaza	Weslaco	Texas	78596	Recruiting
University of Utah Huntsman Cancer Institute	Salt Lake City	Utah	84112	Recruiting
University of Virginia	Charlottesville	Virginia	22908	Recruiting
Inova Schar Cancer Institute	Fairfax	Virginia	22031	Recruiting
Virginia Cancer Specialists, PC	Fairfax	Virginia	22031	Withdrawn
Virginia Oncology Associates	Norfolk	Virginia	23502	Withdrawn
Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia	23298	Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia	24014	Recruiting
Swedish Cancer Institute - Edmonds Campus	Edmonds	Washington	98026	Recruiting
Swedish Cancer Institute - Issaquah Campus	Issaquah	Washington	98029	Recruiting
Kadlec Clinic Hematology and Oncology	Kennewick	Washington	99336	Recruiting
Swedish Cancer Institute	Seattle	Washington	98104	Recruiting
West Virginia University	Morgantown	West Virginia	26506	Recruiting
University of Wisconsin Carbone Cancer Center	Madison	Wisconsin	53792	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06246916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 18, 2026 · Synced Sep 7, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06246916 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →