NCT06246916From ClinicalTrials.govRecruiting

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)

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

Melanoma

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Regeneron Pharmaceuticals
Enrolment target: 560
Started: 9 September 2024
Main results due: 22 March 2027
Study sites: 112
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(112)

Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Recruiting
Arizona Oncology Associates
Tucson, Arizona, United States
Withdrawn
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Recruiting
Providence Medical Foundation
Fullerton, California, United States
Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Recruiting
University of California Los Angeles
Los Angeles, California, United States
Recruiting
St. Joseph Hospital Orange
Orange, California, United States
Recruiting
University of California Irvine, UCI Medical Center
Orange, California, United States
Recruiting
Eisenhower Medical Center
Rancho Mirage, California, United States
Withdrawn
Emad Ibrahim, MD, Inc.
Redlands, California, United States
Recruiting
Sutter Health
Sacramento, California, United States
Recruiting
University of California San Francisco (UCSF)
San Francisco, California, United States
Recruiting
Sansum Clinic
Santa Barbara, California, United States
Withdrawn
St John's Cancer Institute
Santa Monica, California, United States
Recruiting
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
Recruiting
University of Colorado Cancer Center
Aurora, Colorado, United States
Recruiting
The Melanoma And Skin Cancer Institute
Englewood, Colorado, United States
Recruiting
UCHealth
Fort Collins, Colorado, United States
Withdrawn
Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Clermont Oncology Center
Clermont, Florida, United States
Withdrawn
Mayo Clinic Florida
Jacksonville, Florida, United States
Recruiting
Cancer Specialist of North Florida
Jacksonville, Florida, United States
Withdrawn
Boca Raton Clinical Research (BRCR) Global
Tamarac, Florida, United States
Recruiting
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
University Cancer & Blood Center
Athens, Georgia, United States
Recruiting
John B. Amos Cancer Center
Columbus, Georgia, United States
Withdrawn
Beacon Clinic
Coeur d'Alene, Idaho, United States
Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Recruiting
Illinois CancerCare
Peoria, Illinois, United States
Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, United States
Recruiting
Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, United States
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Recruiting
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Withdrawn
Henry Ford Cancer Institute/Henry Ford Health System
Detroit, Michigan, United States
Recruiting
Minnesota Oncology Hematology, P.A
Fridley, Minnesota, United States
Recruiting
Allina Health Cancer Institute
Minneapolis, Minnesota, United States
Recruiting
VA St. Louis Healthcare System
St Louis, Missouri, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Mercy South
St Louis, Missouri, United States
Recruiting
St. Vincent Healthcare
Billings, Montana, United States
Withdrawn
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Recruiting
John Theurer Cancer Center
Hackensack, New Jersey, United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Recruiting
The Valley Hospital Inc.
Paramus, New Jersey, United States
Recruiting
New York Oncology Hematology
Albany, New York, United States
Recruiting
Messino Cancer Center
Asheville, North Carolina, United States
Recruiting
Levine Cancer Institute
Charlotte, North Carolina, United States
Recruiting
Novant Health Cancer Institute
Charlotte, North Carolina, United States
Recruiting
Novant Health Weisiger Cancer Institute - Charlotte
Charlotte, North Carolina, United States
Recruiting
Duke Health System
Durham, North Carolina, United States
Recruiting
Novant Health Zimmer Cancer Institute - Wilmington
Wilmington, North Carolina, United States
Recruiting
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States
Recruiting
Seidman Cancer Center
Cleveland, Ohio, United States
Recruiting

Showing 60 of 112 sites — filter to narrow it down. 98 of the 112 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06246916. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me