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MelanomaPhase 3NCT06246916

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 testing fianlimab, cemiplimab and relatlimab+nivolumab in people with Melanoma, run by Regeneron Pharmaceuticals at 113 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
fianlimab, cemiplimab and relatlimab+nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
560 participants
Where
113 sitesin 2 countries
Study dates
9 Sep 2024to 10 Jul 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
  • Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
  • Measurable disease per RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
  • Adequate bone marrow, hepatic, and kidney function
  • Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol

Who cannot join

  • Medical Conditions:
  • Uveal, acral or mucosal melanoma.
  • Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
  • 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:
  • Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
Show all 12Show fewer
  • Systemic immune suppression as described in the protocol.
  • Other Comorbidities:
  • Participants with a history of myocarditis.
  • Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN).
  • Active or untreated brain metastases or spinal cord compression as described in the protocol.
  • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Trial locations and contacts

113 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

113 sites in 2 countries

United States106 sites, 85 recruiting

  • New York Oncology Hematology

    Albany, New York, 12206

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • Messino Cancer Center

    Asheville, North Carolina, 28806

    Recruiting

  • University Cancer & Blood Center

    Athens, Georgia, 30607

    Recruiting

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    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 - South Austin, South Austin Cancer Center

    Austin, Texas, 78745

    Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

    Withdrawn

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

    Recruiting

  • St. Vincent Healthcare

    Billings, Montana, 59102

    Withdrawn

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

    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

  • University of Virginia

    Charlottesville, Virginia, 22908

    Recruiting

  • Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee, 37404

    Recruiting

  • Oncology Hematology Care Clinical Trials

    Cincinnati, Ohio, 45242

    Withdrawn

  • Clermont Oncology Center

    Clermont, Florida, 34711

    Withdrawn

  • Seidman Cancer Center

    Cleveland, Ohio, 44106

    Recruiting

  • Beacon Clinic

    Coeur d'Alene, Idaho, 83815

    Recruiting

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

    Recruiting

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

    Withdrawn

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Recruiting

  • Texas Oncology - Medical City

    Dallas, Texas, 75230

    Recruiting

  • Texas Oncology

    Dallas, Texas, 75246

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Withdrawn

  • Henry Ford Cancer Institute/Henry Ford Health System

    Detroit, Michigan, 48202

    Recruiting

  • Duke Health System

    Durham, North Carolina, 27710

    Recruiting

  • St. Luke's University Health Network

    Easton, Pennsylvania, 18045

    Recruiting

  • Swedish Cancer Institute - Edmonds Campus

    Edmonds, Washington, 98026

    Recruiting

  • The Melanoma And Skin Cancer Institute

    Englewood, Colorado, 80113

    Recruiting

  • USOR Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

    Recruiting

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

    Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

    Withdrawn

  • UCHealth

    Fort Collins, Colorado, 80528

    Withdrawn

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46825

    Recruiting

  • Center For Disease And Blood Disorder

    Fort Worth, Texas, 76104

    Withdrawn

  • Texas Oncology - Fort Worth

    Fort Worth, Texas, 76104

    Recruiting

  • Minnesota Oncology Hematology, P.A

    Fridley, Minnesota, 55432

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Recruiting

  • Texas Oncology - Grapevine

    Grapevine, Texas, 76051

    Recruiting

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

    Withdrawn

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Texas Oncology - Harlingen, Medical Arts Pavillion

    Harlingen, Texas, 78550

    Recruiting

  • Penn State Health Milton South Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Swedish Cancer Institute - Issaquah Campus

    Issaquah, Washington, 98029

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Recruiting

  • Cancer Specialist of North Florida

    Jacksonville, Florida, 32256

    Withdrawn

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Recruiting

  • Markey Cancer Center Clinical Research Organization

    Lexington, Kentucky, 40536

    Completed

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Withdrawn

  • Texas Oncology - Longview

    Longview, Texas, 75601

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Recruiting

  • University of California Los Angeles

    Los Angeles, California, 90024

    Recruiting

  • Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas, 79410

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Recruiting

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

    Recruiting

  • Allina Health Cancer Institute

    Minneapolis, Minnesota, 55407

    Withdrawn

  • West Virginia University

    Morgantown, West Virginia, 26506

    Recruiting

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Withdrawn

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Recruiting

  • St. Joseph Hospital Orange

    Orange, California, 92868

    Recruiting

  • University of California Irvine, UCI Medical Center

    Orange, California, 92868

    Recruiting

  • Texas Oncology-Palestine Cancer Center

    Palestine, Texas, 75801

    Recruiting

  • The Valley Hospital Inc.

    Paramus, New Jersey, 07652

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Recruiting

  • Illinois CancerCare

    Peoria, Illinois, 61615

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Kaiser Foundation Hospitals

    Portland, Oregon, 97227

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903

    Recruiting

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

    Withdrawn

  • Emad Ibrahim, MD, Inc.

    Redlands, California, 92373

    Recruiting

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298

    Recruiting

  • Oncology & Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

    Recruiting

  • Sutter Health

    Sacramento, California, 95816

    Recruiting

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    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

    Withdrawn

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    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

  • Boca Raton Clinical Research (BRCR) Global

    Tamarac, Florida, 33321

    Recruiting

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Arizona Oncology Associates

    Tucson, Arizona, 85711

    Withdrawn

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

    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

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Recruiting

  • Novant Health Zimmer Cancer Institute - Wilmington

    Wilmington, North Carolina, 28401

    Recruiting

Other trials in United States

Canada7 sites, 7 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • London Regional Cancer Centre

    London, Ontario, N6A 5W9

    Recruiting

  • Jewish General Hospital - Main Address

    Montreal, Quebec, H3T 1E2

    Recruiting

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

    Québec, G1J 0J9

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

About this study

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

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
Being tested
fianlimab, cemiplimab, relatlimab+nivolumab
Keywords
Unresectable Melanoma, Metastatic Melanoma, Advanced Melanoma, Stage III, Stage IV
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fianlimabDrug

    Also called REGN3767

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

  • cemiplimabDrug

    Also called REGN2810, LIBTAYO®

    IV administration Q3W in combination with fianlimab

  • relatlimab+nivolumabDrug

    Also called Opdualag™

    IV administration every 4 weeks (Q4W)

Study groups in NCT06246916
Study groupRoleWhat they receive
fianlimab+cemiplimabExperimentalRandomized 1:1
Receives: Drug: fianlimab; Drug: cemiplimab
relatlimab+nivolumabActive comparatorRandomized 1:1
Receives: Drug: relatlimab+nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)

    Measured: Up to 72 months

Secondary outcomes (24)

  1. Progression free survival (PFS) RECIST version 1.1 based on BICR

    Measured: Up to 72 months

  2. Death from any cause

    Measured: Up to 72 months

  3. Overall survival (OS)

    Measured: Up to 72 months

  4. Duration of Response (DOR) by BICR

    Measured: Up to 72 months

  5. DOR by investigator assessment

    Measured: Up to 72 months

  6. Disease control rate (DCR) by BICR

    Measured: Up to 72 months

  7. DCR by investigator assessment

    Measured: Up to 72 months

  8. ORR based on investigator assessment according to RECIST version 1.1

    Measured: Up to 72 months

  9. PFS based on investigator assessment according to RECIST version 1.1

    Measured: Up to 72 months

  10. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: Up to 72 months

  11. Incidence of serious adverse events (SAEs)

    Measured: Up to 72 months

  12. Incidence of immune-mediated adverse events (imAEs)

    Measured: Up to 72 months

  13. Occurrence of interruption of study drug(s) due to AEs

    Measured: Up to 72 months

  14. Occurrence of discontinuation of study drug(s) due to AEs

    Measured: Up to 72 months

  15. TEAEs leading to death

    Measured: Up to 72 months

  16. Incidence of laboratory abnormalities

    Grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests

    Measured: Up to 72 months

  17. Concentration of fianlimab in serum

    Measured: Up to 72 months

  18. Concentration of cemiplimab in serum

    Measured: Up to 72 months

  19. Incidence of anti-drug antibodies (ADAs) to fianlimab

    Measured: Up to 72 months

  20. Titer of ADAs to fianlimab

    Measured: Up to 72 months

  21. Incidence of ADAs to cemiplimab

    Measured: Up to 72 months

  22. Titer of ADAs to cemiplimab

    Measured: Up to 72 months

  23. Incidence of neutralizing antibodies (NAbs) to fianlimab

    Measured: Up to 72 months

  24. Incidence of NAbs to cemiplimab

    Measured: Up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start9 Sep 2024
  3. Primary completion22 Mar 2027 (estimated)
  4. Study completion10 Jul 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06246916
Sponsor's protocol ID
R3767-ONC-22122
Status last verified
Nov 2026
First submitted
30 Jan 2024
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fianlimab, cemiplimab and relatlimab+nivolumab in people with Melanoma, run by Regeneron Pharmaceuticals at 113 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06246916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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