En undersøgelse med kombinationer af anti-LAG-3 og anti-PD-1 antistoffer hos voksne deltagere med avanceret eller metastatisk melanom
5. november 2026 opdateret af: Regeneron Pharmaceuticals
Et fase 3-studie af faste dosiskombinationer af Fianlimab og Cemiplimab versus Relatlimab og Nivolumab hos deltagere med uoperabelt eller metastatisk melanom
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)
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
560
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Studiesteder
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Québec, Canada, G1J 0J9
- Rekruttering
- Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Rekruttering
- Arthur J.E. Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Rekruttering
- Cross Cancer Institute
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Ontario
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London, Ontario, Canada, N6A 5W9
- Rekruttering
- London Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre
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Toronto, Ontario, Canada, M4N 3M5
- Rekruttering
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Rekruttering
- Jewish General Hospital - Main Address
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Rekruttering
- Ironwood Cancer & Research Centers
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Gilbert, Arizona, Forenede Stater, 85234
- Rekruttering
- Banner MD Anderson Cancer Center
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Tucson, Arizona, Forenede Stater, 85711
- Trukket tilbage
- Arizona Oncology Associates
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Trukket tilbage
- University of Arkansas for Medical Sciences
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California
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Fullerton, California, Forenede Stater, 92835
- Rekruttering
- Providence Medical Foundation
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Los Alamitos, California, Forenede Stater, 90720
- Rekruttering
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Forenede Stater, 90024
- Rekruttering
- University of California Los Angeles
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Orange, California, Forenede Stater, 92868
- Rekruttering
- St. Joseph Hospital Orange
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Orange, California, Forenede Stater, 92868
- Rekruttering
- University of California Irvine, UCI Medical Center
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Rancho Mirage, California, Forenede Stater, 92270
- Trukket tilbage
- Eisenhower Medical Center
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Redlands, California, Forenede Stater, 92373
- Rekruttering
- Emad Ibrahim, MD, Inc.
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Sacramento, California, Forenede Stater, 95816
- Rekruttering
- Sutter Health
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San Francisco, California, Forenede Stater, 94143
- Rekruttering
- University of California San Francisco (UCSF)
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Santa Barbara, California, Forenede Stater, 93105
- Trukket tilbage
- Sansum Clinic
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Santa Monica, California, Forenede Stater, 90404
- Trukket tilbage
- St John's Cancer Institute
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- University of Colorado Cancer Center
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- Rocky Mountain Regional VA Medical Center
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Englewood, Colorado, Forenede Stater, 80113
- Rekruttering
- The Melanoma And Skin Cancer Institute
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Fort Collins, Colorado, Forenede Stater, 80528
- Trukket tilbage
- UCHealth
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
- Yale Cancer Center
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Florida
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Clermont, Florida, Forenede Stater, 34711
- Trukket tilbage
- Clermont Oncology Center
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic Florida
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Jacksonville, Florida, Forenede Stater, 32256
- Trukket tilbage
- Cancer Specialist of North Florida
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Tamarac, Florida, Forenede Stater, 33321
- Rekruttering
- Boca Raton Clinical Research (BRCR) Global
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- H. Lee Moffitt Cancer Center
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Georgia
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Athens, Georgia, Forenede Stater, 30607
- Rekruttering
- University Cancer & Blood Center
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Columbus, Georgia, Forenede Stater, 31904
- Trukket tilbage
- John B. Amos Cancer Center
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Idaho
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Coeur d'Alene, Idaho, Forenede Stater, 83815
- Rekruttering
- Beacon Clinic
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Illinois
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Hinsdale, Illinois, Forenede Stater, 60521
- Rekruttering
- Hope and Healing Cancer Services
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Park Ridge, Illinois, Forenede Stater, 60068
- Rekruttering
- Advocate Lutheran General Hospital
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Peoria, Illinois, Forenede Stater, 61615
- Rekruttering
- Illinois CancerCare
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46825
- Rekruttering
- Fort Wayne Medical Oncology and Hematology
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Kansas
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Westwood, Kansas, Forenede Stater, 66205
- Rekruttering
- The University of Kansas Cancer Center
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- Afsluttet
- Markey Cancer Center Clinical Research Organization
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Trukket tilbage
- Mary Bird Perkins Cancer Center
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Maryland
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Columbia, Maryland, Forenede Stater, 21044
- Rekruttering
- Maryland Oncology Hematology, P.A.
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- Rekruttering
- University of Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Trukket tilbage
- Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48202
- Rekruttering
- Henry Ford Cancer Institute/Henry Ford Health System
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Minnesota
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Fridley, Minnesota, Forenede Stater, 55432
- Rekruttering
- Minnesota Oncology Hematology, P.A
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Minneapolis, Minnesota, Forenede Stater, 55407
- Trukket tilbage
- Allina Health Cancer Institute
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School of Medicine
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St Louis, Missouri, Forenede Stater, 63128
- Rekruttering
- Mercy South
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St Louis, Missouri, Forenede Stater, 63106
- Rekruttering
- VA St. Louis Healthcare System
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Montana
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Billings, Montana, Forenede Stater, 59102
- Trukket tilbage
- St. Vincent Healthcare
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68130
- Rekruttering
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89148
- Rekruttering
- Comprehensive Cancer Centers of Nevada
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Rekruttering
- Dartmouth Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Rekruttering
- John Theurer Cancer Center
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New Brunswick, New Jersey, Forenede Stater, 08901
- Rekruttering
- Rutgers Cancer Institute of New Jersey
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Paramus, New Jersey, Forenede Stater, 07652
- Rekruttering
- The Valley Hospital Inc.
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New York
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Albany, New York, Forenede Stater, 12206
- Rekruttering
- New York Oncology Hematology
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28806
- Rekruttering
- Messino Cancer Center
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Charlotte, North Carolina, Forenede Stater, 28204
- Rekruttering
- Levine Cancer Institute
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Charlotte, North Carolina, Forenede Stater, 28204
- Rekruttering
- Novant Health Cancer Institute
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Charlotte, North Carolina, Forenede Stater, 28204
- Rekruttering
- Novant Health Weisiger Cancer Institute - Charlotte
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Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke Health System
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Wilmington, North Carolina, Forenede Stater, 28401
- Rekruttering
- Novant Health Zimmer Cancer Institute - Wilmington
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45242
- Trukket tilbage
- Oncology Hematology Care Clinical Trials
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- Seidman Cancer Center
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Columbus, Ohio, Forenede Stater, 43210
- Rekruttering
- The Ohio State University Wexner Medical Center
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74146
- Rekruttering
- Oklahoma Cancer Specialists and Research Institute, LLC
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- USOR Willamette Valley Cancer Institute and Research Center
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health and Science University
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Portland, Oregon, Forenede Stater, 97227
- Rekruttering
- Kaiser Foundation Hospitals
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Pennsylvania
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Easton, Pennsylvania, Forenede Stater, 18045
- Rekruttering
- St. Luke's University Health Network
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Hershey, Pennsylvania, Forenede Stater, 17033
- Rekruttering
- Penn State Health Milton South Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Rekruttering
- Fox Chase Cancer Center
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- Rekruttering
- University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rekruttering
- Lifespan Cancer Institute
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Trukket tilbage
- Saint Francis Cancer Center
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Rekruttering
- Tennessee Oncology - Chattanooga
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Knoxville, Tennessee, Forenede Stater, 37920
- Rekruttering
- University of Tennessee Medical Center
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Oncology
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Sarah Cannon Research Institute (SCRI) Oncology Partners
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Texas
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Austin, Texas, Forenede Stater, 78731
- Rekruttering
- Texas Oncology - Austin Central, Central Austin Cancer Center
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Austin, Texas, Forenede Stater, 78705
- Rekruttering
- Texas Oncology - Austin Midtown, Midtown Medical Center I
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Austin, Texas, Forenede Stater, 78745
- Rekruttering
- Texas Oncology - South Austin, South Austin Cancer Center
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Bedford, Texas, Forenede Stater, 76022
- Rekruttering
- Texas Oncology - Bedford
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Dallas, Texas, Forenede Stater, 75246
- Rekruttering
- Texas Oncology
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Dallas, Texas, Forenede Stater, 75230
- Rekruttering
- Texas Oncology - Medical City
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Fort Worth, Texas, Forenede Stater, 76104
- Rekruttering
- Texas Oncology - Fort Worth
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Fort Worth, Texas, Forenede Stater, 76104
- Trukket tilbage
- Center For Disease And Blood Disorder
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Grapevine, Texas, Forenede Stater, 76051
- Rekruttering
- Texas Oncology - Grapevine
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Harlingen, Texas, Forenede Stater, 78550
- Rekruttering
- Texas Oncology - Harlingen, Medical Arts Pavillion
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- The University of Texas MD Anderson Cancer Center
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Longview, Texas, Forenede Stater, 75601
- Rekruttering
- Texas Oncology - Longview
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Lubbock, Texas, Forenede Stater, 79410
- Rekruttering
- Joe Arrington Cancer Research & Treatment Center
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McAllen, Texas, Forenede Stater, 78503
- Rekruttering
- Texas Oncology - McAllen
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Palestine, Texas, Forenede Stater, 75801
- Rekruttering
- Texas Oncology-Palestine Cancer Center
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Tyler, Texas, Forenede Stater, 75701
- Trukket tilbage
- The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
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Tyler, Texas, Forenede Stater, 75702
- Trukket tilbage
- Texas Oncology-Tyler, Northeast Texas Cancer Institute
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Weslaco, Texas, Forenede Stater, 78596
- Rekruttering
- Texas Oncology - Weslaco, Knapp Medical Plaza
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- University of Utah Huntsman Cancer Institute
-
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- Rekruttering
- University of Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Inova Schar Cancer Institute
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Fairfax, Virginia, Forenede Stater, 22031
- Trukket tilbage
- Virginia Cancer Specialists, PC
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Norfolk, Virginia, Forenede Stater, 23502
- Trukket tilbage
- Virginia Oncology Associates
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Richmond, Virginia, Forenede Stater, 23298
- Rekruttering
- Virginia Commonwealth University Massey Cancer Center
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Roanoke, Virginia, Forenede Stater, 24014
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.
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Washington
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Edmonds, Washington, Forenede Stater, 98026
- Rekruttering
- Swedish Cancer Institute - Edmonds Campus
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Issaquah, Washington, Forenede Stater, 98029
- Rekruttering
- Swedish Cancer Institute - Issaquah Campus
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Kennewick, Washington, Forenede Stater, 99336
- Rekruttering
- Kadlec Clinic Hematology and Oncology
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Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Swedish Cancer Institute
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506
- Rekruttering
- West Virginia University
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- Rekruttering
- University of Wisconsin Carbone Cancer Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
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
-
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: fianlimab+cemiplimab
Randomized 1:1 |
Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
Andre navne:
IV administration Q3W in combination with fianlimab
Andre navne:
|
|
Aktiv komparator: relatlimab+nivolumab
Randomized 1:1 |
IV administration every 4 weeks (Q4W)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Objektiv responsrate (ORR) pr. responsevalueringskriterier i solide tumorer (RECIST) version 1.1 baseret på blindet uafhængig central gennemgang (BICR)
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progressionsfri overlevelse (PFS) RECIST version 1.1 baseret på BICR
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Død af enhver årsag
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Samlet overlevelse (OS)
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Varighed af respons (DOR) af BICR
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
DOR ved efterforskers vurdering
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Disease control rate (DCR) ved BICR
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
DCR ved investigator vurdering
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
ORR baseret på investigators vurdering i henhold til RECIST version 1.1
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
PFS baseret på investigators vurdering i henhold til RECIST version 1.1
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af behandlingsfremkomne bivirkninger (TEAE'er)
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af alvorlige bivirkninger (SAE)
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af immunmedierede bivirkninger (imAE'er)
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af afbrydelse af undersøgelseslægemidler på grund af AE'er
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af seponering af forsøgslægemidler på grund af bivirkninger
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
TEAE'er fører til døden
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Koncentration af fianlimab i serum
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Koncentration af cemiplimab i serum
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af anti-lægemiddel-antistoffer (ADA'er) mod fianlimab
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Titer på ADA'er til fianlimab
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af ADA'er til cemiplimab
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Titer af ADA'er til cemiplimab
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af neutraliserende antistoffer (NAbs) mod fianlimab
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Forekomst af NAbs til cemiplimab
Tidsramme: Op til 72 måneder
|
Op til 72 måneder
|
|
|
Incidence of laboratory abnormalities
Tidsramme: Up to 72 months
|
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 |
Up to 72 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
9. september 2024
Primær færdiggørelse (Anslået)
Primær færdiggørelse
22. marts 2027
Studieafslutning (Anslået)
Studieafslutning
10. juli 2033
Datoer for studieregistrering
Først indsendt
Først indsendt
30. januar 2024
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
30. januar 2024
Først opslået (Faktiske)
Først opslået
7. februar 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
6. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2026
Sidst verificeret
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- R3767-ONC-22122
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-delingstidsramme
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy.
IPD-delingsadgangskriterier
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .