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New hope for advanced melanoma: experimental combo faces off against approved treatment

NCT ID NCT06246916

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This study tests whether a new combination of drugs (fianlimab and cemiplimab) works better than an already approved treatment (Opdualag) for people with advanced melanoma that cannot be removed by surgery or has spread. About 560 adults with previously untreated melanoma will receive either the experimental combo or the approved one. The goal is to see which shrinks tumors more safely and effectively.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 560 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jul 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    97 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Lutheran General Hospital

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Allina Health Cancer Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Arizona Oncology Associates

    WITHDRAWN

    Tucson, Arizona, 85711, United States

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Beacon Clinic

    RECRUITING

    Coeur d'Alene, Idaho, 83815, United States

  • Boca Raton Clinical Research (BRCR) Global

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Cancer Specialist of North Florida

    WITHDRAWN

    Jacksonville, Florida, 32256, United States

  • Cancer and Blood Specialty Clinic

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Center For Disease And Blood Disorder

    RECRUITING

    Fort Worth, Texas, 76104, United States

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

    RECRUITING

    Québec, G1J 0J9, Canada

  • Clermont Oncology Center

    WITHDRAWN

    Clermont, Florida, 34711, United States

  • Comprehensive Cancer Centers of Nevada

    RECRUITING

    Las Vegas, Nevada, 89148, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Duke Health System

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Eisenhower Medical Center

    WITHDRAWN

    Rancho Mirage, California, 92270, United States

  • Emad Ibrahim, MD, Inc.

    RECRUITING

    Redlands, California, 92373, United States

  • Fort Wayne Medical Oncology and Hematology

    RECRUITING

    Fort Wayne, Indiana, 46825, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • H. Lee Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Henry Ford Cancer Institute/Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hope and Healing Cancer Services

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Illinois CancerCare

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Inova Schar Cancer Institute

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Ironwood Cancer & Research Centers

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Jewish General Hospital - Main Address

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Joe Arrington Cancer Research & Treatment Center

    RECRUITING

    Lubbock, Texas, 79410, United States

  • John B. Amos Cancer Center

    WITHDRAWN

    Columbus, Georgia, 31904, United States

  • John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kadlec Clinic Hematology and Oncology

    RECRUITING

    Kennewick, Washington, 99336, United States

  • Kaiser Foundation Hospitals

    RECRUITING

    Portland, Oregon, 97227, United States

  • Karmanos Cancer Institute

    WITHDRAWN

    Detroit, Michigan, 48201, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Lifespan Cancer Institute

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • London Regional Cancer Centre

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Markey Cancer Center Clinical Research Organization

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • Mary Bird Perkins Cancer Center

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Maryland Oncology Hematology, P.A.

    RECRUITING

    Columbia, Maryland, 21044, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mercy South

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Messino Cancer Center

    RECRUITING

    Asheville, North Carolina, 28806, United States

  • Minnesota Oncology Hematology, P.A

    RECRUITING

    Fridley, Minnesota, 55432, United States

  • New York Oncology Hematology

    RECRUITING

    Albany, New York, 12206, United States

  • Novant Health Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Novant Health Weisiger Cancer Institute - Charlotte

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Novant Health Zimmer Cancer Institute - Wilmington

    RECRUITING

    Wilmington, North Carolina, 28401, United States

  • Oklahoma Cancer Specialists and Research Institute, LLC

    RECRUITING

    Tulsa, Oklahoma, 74146, United States

  • Oncology & Hematology Associates of Southwest Virginia, Inc.

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Oncology Hematology Care Clinical Trials

    RECRUITING

    Cincinnati, Ohio, 45242, United States

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

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Penn State Health Milton South Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • Rocky Mountain Regional VA Medical Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Saint Francis Cancer Center

    WITHDRAWN

    Greenville, South Carolina, 29607, United States

  • Sansum Clinic

    WITHDRAWN

    Santa Barbara, California, 93105, United States

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seidman Cancer Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • St John's Cancer Institute

    RECRUITING

    Santa Monica, California, 90404, United States

  • St. Joseph Hospital Orange

    RECRUITING

    Orange, California, 92868, United States

  • St. Luke's University Health Network

    RECRUITING

    Easton, Pennsylvania, 18045, United States

  • St. Vincent Healthcare

    WITHDRAWN

    Billings, Montana, 59102, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Sutter Health

    RECRUITING

    Sacramento, California, 95816, United States

  • Swedish Cancer Institute

    RECRUITING

    Seattle, Washington, 98104, United States

  • Swedish Cancer Institute - Edmonds Campus

    RECRUITING

    Edmonds, Washington, 98026, United States

  • Swedish Cancer Institute - Issaquah Campus

    RECRUITING

    Issaquah, Washington, 98029, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology - Chattanooga

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Texas Oncology

    RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology - Austin Central, Central Austin Cancer Center

    RECRUITING

    Austin, Texas, 78731, United States

  • Texas Oncology - Austin Midtown, Midtown Medical Center I

    RECRUITING

    Austin, Texas, 78705, United States

  • Texas Oncology - Bedford

    RECRUITING

    Bedford, Texas, 76022, United States

  • Texas Oncology - Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Texas Oncology - Grapevine

    RECRUITING

    Grapevine, Texas, 76051, United States

  • Texas Oncology - Harlingen, Medical Arts Pavillion

    RECRUITING

    Harlingen, Texas, 78550, United States

  • Texas Oncology - Longview

    RECRUITING

    Longview, Texas, 75601, United States

  • Texas Oncology - McAllen

    RECRUITING

    McAllen, Texas, 78503, United States

  • Texas Oncology - Medical City

    RECRUITING

    Dallas, Texas, 75230, United States

  • Texas Oncology - Weslaco, Knapp Medical Plaza

    RECRUITING

    Weslaco, Texas, 78596, United States

  • Texas Oncology-Palestine Cancer Center

    RECRUITING

    Palestine, Texas, 75801, United States

  • Texas Oncology-Tyler, Northeast Texas Cancer Institute

    WITHDRAWN

    Tyler, Texas, 75702, United States

  • The Melanoma And Skin Cancer Institute

    RECRUITING

    Englewood, Colorado, 80113, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center

    WITHDRAWN

    Tyler, Texas, 75701, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The Valley Hospital Inc.

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • UCHealth

    WITHDRAWN

    Fort Collins, Colorado, 80528, United States

  • USOR Willamette Valley Cancer Institute and Research Center

    RECRUITING

    Eugene, Oregon, 97401, United States

  • University Cancer & Blood Center

    RECRUITING

    Athens, Georgia, 30607, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California Irvine, UCI Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90024, United States

  • University of California San Francisco (UCSF)

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Tennessee Medical Center

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • University of Utah Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • VA St. Louis Healthcare System

    RECRUITING

    St Louis, Missouri, 63106, United States

  • Virginia Cancer Specialists, PC

    WITHDRAWN

    Fairfax, Virginia, 22031, United States

  • Virginia Commonwealth University Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Virginia Oncology Associates

    WITHDRAWN

    Norfolk, Virginia, 23502, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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