En studie för att utvärdera överlägsenheten hos kombinationen Fianlimab och Cemiplimab jämfört med Pembrolizumab hos vuxna och ungdomar med fullständigt resekerad högriskhudcancer
En fas 3-studie av Fianlimab (Anti-LAG-3) och Cemiplimab versus Pembrolizumab i adjuvantmiljö hos patienter med fullständigt resekerat högriskmelanom
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab.
The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting.
The study is looking at several other research questions, including:
- What side effects may happen from receiving the study drugs.
- How much study drug is in the blood at different times.
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.
- How administering the study drugs might improve quality of life.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Caba, Argentina, 1061
- DIABAID - Instituto de Asistencia Integral en Diabetes
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Buenos Aires
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Caba, Buenos Aires, Argentina, 1125
- Fundacion Centro de Investigaciones para la Transformacion (CENIT)
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Pergamino, Buenos Aires, Argentina, B2700CPM
- Centro de Investigacion Pergamino
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Río Negro Province
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Viedma, Río Negro Province, Argentina, 8500
- Clinica Viedma S.A.
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000KZE
- Instituto de Oncologia de Rosario
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Centro Medico San Roque
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New South Wales
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Blacktown, New South Wales, Australien, 2148
- Blacktown Cancer and Haematology Centre - Blacktown Hospital
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Lismore, New South Wales, Australien, 2480
- Lismore Base Hospital
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Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital - Cancer Therapy Centre
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Wollstonecraft, New South Wales, Australien, 2065
- Melanoma Institute of Australia
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South Australia
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Bedford Park, South Australia, Australien, 5042
- Flinders Medical Centre
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North Adelaide, South Australia, Australien, 5006
- Calvary North Adelaide Hospital
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Victoria
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Box Hill, Victoria, Australien, 3128
- Eastern Health
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Geelong, Victoria, Australien, 3220
- Andrew Love Cancer Centre
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Melbourne, Victoria, Australien, 3004
- Alfred Hospital
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Western Australia
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Nedlands, Western Australia, Australien, 6009
- One Clinical Research at Hollywood Private Hospital
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint-Luc
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Oost-Vlaanderen
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Sint-Niklaas, Oost-Vlaanderen, Belgien, 9100
- Vitaz campus Sint-Niklaas Moerland
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West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgien, 8500
- AZ Groeninge
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Rio de Janeiro, Brasilien, 23793-080
- Instituto COI
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São Paulo, Brasilien, 01236030
- Hemomed
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São Paulo, Brasilien, 04014-002
- Sao Camilo Oncologia
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São Paulo, Brasilien, 01308-050
- Hospital Sirio Libanes
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30130-090
- Hospital das Clinicas da Universidade Federal de Minas Gerais
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Paraná
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Curitiba, Paraná, Brasilien, 81520-060
- Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brasilien, 98700-000
- Oncosite Centro De Pesquisa Em Oncologia
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Passo Fundo, Rio Grande do Sul, Brasilien, 99010-090
- Instituto do Cancer em Hospital Sao Vicente de Paulo
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035007
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasilien, 90619900
- Centro de Pesquisa em Oncologia PUCRS
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Porto Alegre, Rio Grande do Sul, Brasilien, 90440140
- Hospital Moinhos de vento
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Rio de Janeiro
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Santo Cristo, Rio de Janeiro, Brasilien, 20220-410
- INCA Instituto Nacional de Cancer
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Santa Catarina
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Itajaí, Santa Catarina, Brasilien, 88301-220
- Catarina Pesquisa Clinica
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Joinville, Santa Catarina, Brasilien, 89201260
- Instituto Joinvilense de Hematologia e Oncologia
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Lages, Santa Catarina, Brasilien, 88501-001
- Animi Unidade de Tratamento Oncologico
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São Paulo
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Barretos, São Paulo, Brasilien, 14784400
- Fundacao Pio XII - Hospital de Amor
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Sorocaba, São Paulo, Brasilien, 18052-210
- Unimed Sorocaba
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São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7560907
- Centro Oncologia de Precision Universidad Mayor
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Santiago, Santiago Metropolitan, Chile, 7550000
- Clinica UC San Carlos de Apoquindo
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
- Oncocentro APYS
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Avignon, Frankrike, 84918
- Sainte Catherine Institut du Cancer Avignon Provence
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Boulogne-Billancourt, Frankrike, 92100
- N_Hôpital Ambroise-Paré
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Clermont-Ferrand, Frankrike, 63003
- CHU Estaing
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Nice, Frankrike, 06202
- Centre Hospitalier Universitaire De Nice Hopital De L Archet
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Valence, Frankrike, 26000
- Centre Hospitalier de Valence
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Villejuif, Frankrike, 94805
- Institut Gustave Roussy
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Bourgogne-Franche-Comté
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Dijon, Bourgogne-Franche-Comté, Frankrike, 21000
- Centre Georges Francois Leclerc
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Burgundy
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Dijon, Burgundy, Frankrike, 21000
- CHU-Dijon
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Doubs
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Besançon, Doubs, Frankrike, 25000
- Besancon Regional University Hospital Center
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Gironde
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Bordeaux, Gironde, Frankrike, 33075
- Chu De Bordeaux
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrike, 31059
- Institut Claudius Regaud, IUCT-Oncopole
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Hauts-de-France
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Lille, Hauts-de-France, Frankrike, 59000
- CHU de Lille
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Herault
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Montpellier, Herault, Frankrike, 34295
- Service de Dermatologie CHU Saint Eloi
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Isere
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La Tronche, Isere, Frankrike, 38700
- Centre Hospitalier Universitaire Grenoble Alpes
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Normandy
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Caen, Normandy, Frankrike, 14076
- Centre Francois Baclesse (CFB)
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Pays de la Loire Region
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Le Mans, Pays de la Loire Region, Frankrike, 72037
- Centre Hospitalier Le Mans
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Nantes, Pays de la Loire Region, Frankrike, 44093
- Nantes University Hospital
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Picardie
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Amiens, Picardie, Frankrike, 80000
- CHU Amiens-Picardie
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Île-de-France Region
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Bobigny, Île-de-France Region, Frankrike, 93000
- Hopital Avicenne
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Créteil, Île-de-France Region, Frankrike, 94000
- Hospital Henri Mondor
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Paris, Île-de-France Region, Frankrike, 75010
- Saint Louis Hospital
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California
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La Jolla, California, Förenta staterna, 92093
- UC San Diego
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San Francisco, California, Förenta staterna, 94158
- UCSF Medical Center at Mission Bay
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Santa Monica, California, Förenta staterna, 90404
- John Wayne Cancer Institute (JWCI)
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Colorado
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Englewood, Colorado, Förenta staterna, 80113
- The Melanoma And Skin Cancer Institute
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Florida
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Miami, Florida, Förenta staterna, 33176
- Miami Cancer Institute at Baptist Health, Inc.
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Orlando, Florida, Förenta staterna, 32806
- Orlando Health
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Tampa, Florida, Förenta staterna, 33612
- Moffitt Cancer Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Förenta staterna, 48201
- Karmanos Cancer Institute
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New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08901
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, Förenta staterna, 10032
- Columbia University
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New York, New York, Förenta staterna, 10016
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
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Rochester, New York, Förenta staterna, 14642
- University of Rochester
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- Lineberger Comprehensive Cancer Center
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Durham, North Carolina, Förenta staterna, 27710
- Duke Cancer Institute, University Hospital
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University James Comprehensive Cancer Center
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Pennsylvania
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Easton, Pennsylvania, Förenta staterna, 18045
- St Lukes University Health Network
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University Of Pittsburgh
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37920
- University of Tennessee Medical Center
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Nashville, Tennessee, Förenta staterna, 37203-1625
- Tennessee Oncology - Centennial Clinic Location
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Nashville, Tennessee, Förenta staterna, 37203
- Verdi Oncology
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Texas
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Dallas, Texas, Förenta staterna, 75390
- UT Southwestern Medical Center
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Utah
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Murray, Utah, Förenta staterna, 84107
- Intermountain Medical Center
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22903
- University of Virginia Medical Center
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Batumi, Georgien, 6000
- Cancer Center of Adjara
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Tbilisi, Georgien, 0159
- JSC K. Eristavi National Center of Experimental and Clinical Surgery
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Tbilisi, Georgien, 0114
- LTD New Hospitals
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Tbilisi, Georgien, 0112
- Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
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Tbilisi, Georgien, 0112
- Israeli Georgian Medical Research Clinic Helsicore
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Tbilisi, Georgien, 0160
- TIM - Tbilisi Institute of Medicine
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Caucasus
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Tbilisi, Caucasus, Georgien, 0144
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
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-
-
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Thessaloniki, Grekland, 57001
- Interbalkan Medical Center
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Thessaloniki, Grekland, 54007
- Ongology Theageneio Thessaloniki
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Thessaloniki, Grekland, 54622
- BioClinic Thessaloniki
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Attica
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Athens, Attica, Grekland, 11527
- National and Kapodistrian University of Athens
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Neo Faliro, Attica, Grekland, 18547
- Metropolitan Hospital
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-
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-
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Cork, Irland, T12 EC8P
- Cork University Hospital
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Dublin, Irland, D09 V2N0
- Beaumont Hospital
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Dublin, Irland, DO4YN63
- St Vincents University Hospital
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Connacht
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Galway, Connacht, Irland, H91 YR71
- Galway University Hospital
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Jerusalem, Israel, 91120
- Hadassah Medical Organization
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Tel HaShomer, Israel, 5265601
- Sheba Medical Center
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Northern District
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Afula, Northern District, Israel, 18340000
- Haemek Medical Center
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Bari, Italien, 70124
- Istituto dei Tumori
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Cuneo, Italien, 12100
- Azienda Ospedaliera Santa Croce i Carle
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Milan, Italien, 20141
- Istituto Europeo di Oncologia
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Naples, Italien, 80131
- Instituto Nazionale Tumori Fondazione Giovanni Pascale
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Perugia, Italien, 06132
- University of Perugia
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Rome, Italien, 000168
- Fondazione Policlinico Universitrio a. Gemelli - IRCCS
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Rome, Italien, 00128
- Campus Bio-Medico di Roma
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Rome, Italien, 00167
- Istituto Dermopatico dell'Immacolata
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Trento, Italien, 38122
- Santa Chiara Hospital
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Udine, Italien, 33100
- Azienda Sanitaria Universitaria del Friuli Centrale
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An
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Ancona, An, Italien, 60020
- Clinica Oncologica, AOU Riuniti Ancona
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Campania
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Naples, Campania, Italien, 80121
- U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)
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Forli Cesena
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Meldola, Forli Cesena, Italien, 47014
- Istituto Romagnolo per lo Studio dei Tumori (IRST)
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Lombardy
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Milan, Lombardy, Italien, 20089
- Istituto Clinico Humanitas
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New Brunswick
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Fredericton, New Brunswick, Kanada, E3B 5N5
- Dr. Everett Chalmers Hospital
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Ontario
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Barrie, Ontario, Kanada, L4M 6M2
- Royal Victoria Regional Health Centre
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Cancer Centre
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Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Veracruz, Mexiko, 91910
- Faicic Centro de Investigacion Clinica de Veracruz
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Guanajuato
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León, Guanajuato, Mexiko, 37178
- Preparaciones Oncologica SC
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Jalisco
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Guadalajara, Jalisco, Mexiko, 44280
- Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
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Guadalajara, Jalisco, Mexiko, 44670
- Pan American Clinical Research
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Nuevo León
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Monterrey, Nuevo León, Mexiko, 64710
- iCan Oncology
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Sinaloa
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Culiacán, Sinaloa, Mexiko, 80020
- Neurociencias Estudios Clinicos SC
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Yucatán
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Mérida, Yucatán, Mexiko, 97134
- Centro De Atencion E Investigacion Clinica En Oncologia SCP
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Mazxowieckie
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Siedlce, Mazxowieckie, Polen, 08-110
- Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-214
- UCK
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Gdansk, Pomeranian Voivodeship, Polen, 80-219
- Copernicus Podmiot Leczniczy Sp. z o.o.Wojewodzie Centrum Onkologii
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Słupsk, Pomeranian Voivodeship, Polen, 76-200
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
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Wielkopolska
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Poznan, Wielkopolska, Polen, 60-788
- Poznan University of Meidcla Science
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-
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Iași, Rumänien, 700106
- Centrul De Oncologie Euroclinic
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Bucharest
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Bucharest, Bucharest, Rumänien, 022328
- Institute of Oncology Bucharest
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Cluj
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Cluj-Napoca, Cluj, Rumänien, 400015
- Cardiomed
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Cluj-Napoca, Cluj, Rumänien, 400015
- Institute of Oncology Prof. Dr Ion Chirircuta
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Floreşti, Cluj, Rumänien, 407280
- Radiotherapy Center Cluj
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Dolj
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Craiova, Dolj, Rumänien, 200347
- Sfantul Nectarie Oncology Center
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Timiș County
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Timișoara, Timiș County, Rumänien, 300166
- Oncocenter Oncologie Clinica S.R.L
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Timișoara, Timiș County, Rumänien, 300239
- Oncomed
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-
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-
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Barcelona, Spanien, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spanien, 08908
- Catalan Institute of Oncology (ICO) Hospitalet
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Barcelona, Spanien, 08035
- Hospital Vall d'Hebron
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Granada, Spanien, 18014
- Hospital Universitario Virgen de las Nieves
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Lugo, Spanien, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
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Madrid, Spanien, 28046
- Hospital Universitario La Pa<
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Madrid, Spanien, 28050
- Centro Integral Oncologico HM Clara Campal
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Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Maranon
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Seville, Spanien, 41009
- Hospital Universitario Virgen Macarena
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Valencia, Spanien, 46010
- Incliva - Instituto de Investigacion Sanitaria
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Valencia, Spanien, 46009
- Instituto Valenciano de Oncologia
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- H. Germans Trias i Pujol, ICO-Badalona
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Hospital Universitario Marques de Valdecilla
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Catalonia
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Barcelona, Catalonia, Spanien, 08028
- Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanien, 33011
- Hospital Universitario Central De Asturias
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London, Storbritannien, NW1 2PG
- University College London Hospitals
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London, Storbritannien, EC1A 7BE
- Saint Bartholomew's Hospital
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Manchester, Storbritannien, M20 4BX
- The Christie
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Taunton, Storbritannien, TA1 5DA
- Taunton and Somerset NHS Foundation Trust
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Devon
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Exeter, Devon, Storbritannien, EX2 5DW
- Royal Devon and Exeter Hospital NHS Trust
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Lothian
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Edinburgh, Lothian, Storbritannien, EH4 2XU
- Edinburgh Cancer Centre
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Somerset
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Bristol, Somerset, Storbritannien, BS2 8ED
- Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
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Surrey
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Sutton, Surrey, Storbritannien, SM2 5PT
- The Royal Marsden NHS Foundation Trust
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West Midlands
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Coventry, West Midlands, Storbritannien, CV2 2DX
- University Hospital Coventry and Warwickshire Nhs Trust
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-
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Gauteng
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Johannesburg, Gauteng, Sydafrika, 2196
- The Medical Oncology Centre of Rosebank
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Pretoria, Gauteng, Sydafrika, 0081
- Wilgers Oncology Centre
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Western Cape
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Cape Town, Western Cape, Sydafrika, 7925
- Groote Schuur Hospital
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Kraaifontein, Western Cape, Sydafrika, 7570
- Cape Town Oncology Trials
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-
-
-
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Ostrava, Tjeckien, 70852
- University Hospital Ostrava
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Brno Mesto
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Brno, Brno Mesto, Tjeckien, 65653
- Masaryk Memorial Cancer Institute
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North Central Czech Republic
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Hradec Králové, North Central Czech Republic, Tjeckien, 50005
- University Hospital Hradec Kralove
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-
-
-
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Ankara, Turkiet (Türkiye), 06100
- Ozel Liv Hospital
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Ankara, Turkiet (Türkiye), 0906520
- Memorial Ankara Hospital
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Ankara, Turkiet (Türkiye), 06100
- Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
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Ankara, Turkiet (Türkiye), 06010
- Gulhane Research And Training Hospital
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Edirne, Turkiet (Türkiye), 22030
- Trakya University
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Istanbul, Turkiet (Türkiye), 34450
- Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
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Istanbul, Turkiet (Türkiye), 81450
- Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
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Adana
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Yüreğir, Adana, Turkiet (Türkiye), 01230
- Baskent University
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Diyarbakır
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Sur, Diyarbakır, Turkiet (Türkiye), 21200
- Dicle University - Medical Faculty Campus
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Kocaeli
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İzmit, Kocaeli, Turkiet (Türkiye), 41380
- Kocaeli University
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Sehitkamil
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Gaziantep, Sehitkamil, Turkiet (Türkiye), 27584
- Gaziantep Medicalpoint Hospital
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-
-
-
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Berlin, Tyskland, 10117
- Charite Universitaetsmedizin Berlin
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Bremen, Tyskland, 28325
- Klinikum Bremen Ost
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Baden-Wurttemberg
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Mannheim, Baden-Wurttemberg, Tyskland, 68167
- University Medical Center Mannheim
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Tübingen, Baden-Wurttemberg, Tyskland, 72076
- University of Tuebingen
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Bavaria
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Augsburg, Bavaria, Tyskland, 86179
- University Hospital Augsburg
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Erlangen, Bavaria, Tyskland, 91054
- Dermatology Erlangen
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Munich, Bavaria, Tyskland, 80337
- LMU Klinikum
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Regensburg, Bavaria, Tyskland, 93053
- University Hospital of Regensburg
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Hesse
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Darmstadt, Hesse, Tyskland, 64283
- Klinikum Darmstadt GmbH
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Frankfurt am Main, Hesse, Tyskland, 60590
- University Clinic Frankfurt
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Lower Saxony
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Göttingen, Lower Saxony, Tyskland, 37075
- University Medical Center Goettingen
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Mecklenburg-Vorpommern
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Schwerin, Mecklenburg-Vorpommern, Tyskland, 19055
- Helios Kliniken Schwerin
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North Rhine-Westphalia
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Bochum, North Rhine-Westphalia, Tyskland, 44791
- Ruhr University Bochum
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Essen, North Rhine-Westphalia, Tyskland, 45147
- Universitatsklinikum Essen
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Münster, North Rhine-Westphalia, Tyskland, 48157
- Fachklinik Hornheide
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Münster, North Rhine-Westphalia, Tyskland, 48149
- University Hospital Muenster
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Rhineland-Palatinate
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Ludwigshafen am Rhein, Rhineland-Palatinate, Tyskland, D-67063
- Hautklinik
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Saxony
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Dresden, Saxony, Tyskland, 01307
- University Hospital Dresden
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Saxony-Anhalt
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Quedlinburg, Saxony-Anhalt, Tyskland, 06484
- Skin Cancer Center Harz
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Tyskland, 24105
- University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel
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Lübeck, Schleswig-Holstein, Tyskland, 23538
- Universitatsklinikum Schleswig Holstein Campus Luebeck
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Thuringia
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Erfurt, Thuringia, Tyskland, D-99089
- Helios Klinikum Erfurt
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Key Inclusion Criteria:
- All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
- Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
- All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol
Key Exclusion Criteria:
- Uveal melanoma
- Any evidence of residual disease after surgery by imaging, pathology, or cytology.
- Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
- Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
- Participants with a history of myocarditis
- Adolescent patients (≥12 to <18 years old) with body weight <40 kg
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Fianlimab HD + Cemiplimab
Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab |
Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
Andra namn:
Cemiplimab will be administered by IV infusion Q 3 weeks
Andra namn:
|
|
Experimentell: Fianlimab LD + Cemiplimab
Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab |
Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
Andra namn:
Cemiplimab will be administered by IV infusion Q 3 weeks
Andra namn:
|
|
Aktiv komparator: Pembrolizumab
Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo |
Pembrolizumab will be administered by IV infusion Q 3 weeks
Andra namn:
Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Relapse free survival (RSF)
Tidsram: Up to 5 Years
|
Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first. |
Up to 5 Years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tid till global hälsostatus/försämring av livskvalitet enligt EORTC QLQ-C30
Tidsram: Upp till 5 år
|
Upp till 5 år
|
|
|
Tid till fysisk funktionsförsämring enligt EORTC QLQ-C30
Tidsram: Upp till 5 år
|
Upp till 5 år
|
|
|
Tid till funktionsförsämring enligt EORTC QLQ-C30
Tidsram: Upp till 5 år
|
Upp till 5 år
|
|
|
Distant metastasis-free survival (DMFS)
Tidsram: Up to 5 Years
|
Time between the date of randomization and the date of the first distant metastasis. |
Up to 5 Years
|
|
Overall survival (OS)
Tidsram: Up to 5 Years
|
Time from randomization to the date of death. |
Up to 5 Years
|
|
Occurrence of treatment-emergent adverse events (TEAEs)
Tidsram: Up to 5 Years
|
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. |
Up to 5 Years
|
|
Occurrence of immune-mediated EAEs (im-EAEs)
Tidsram: Up to 5 Years
|
imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses. |
Up to 5 Years
|
|
Occurrence of serious adverse events (SAEs)
Tidsram: Up to 5 Years
|
An SAE is any untoward medical occurrence that at any dose:
|
Up to 5 Years
|
|
Occurrence of adverse events of special interest (AESIs)
Tidsram: Up to 5 Years
|
An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it |
Up to 5 Years
|
|
Occurrence of TEAEs resulting in death
Tidsram: Up to 5 Years
|
A TEAE resulting in death is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. |
Up to 5 Years
|
|
Occurrence of dose-limiting toxicity (DLT)
Tidsram: Up to 5 Years
|
A DLT is defined as a study-drug related TEAE, including imAEs, that could preclude enrolling additional adolescent patients at the selected dose. Dose-limiting toxicity will be evaluated in adolescents only. |
Up to 5 Years
|
|
Occurrence of interruption or discontinuation of study drug(s) due to TEAE
Tidsram: Up to 5 Years
|
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. |
Up to 5 Years
|
|
Occurrence of laboratory abnormalities
Tidsram: Up to 5 Years
|
As assessed by the NCI-CTCAE grading system (≥ Grade 3 or higher) |
Up to 5 Years
|
|
Concentrations of fianlimab in serum over time
Tidsram: Up to 5 Years
|
The concentrations of fianlimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients. |
Up to 5 Years
|
|
Concentrations of cemiplimab in serum over time
Tidsram: Up to 5 Years
|
The concentrations of cemiplimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients. |
Up to 5 Years
|
|
Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies
Tidsram: Up to 5 Years
|
Immunogenicity will be characterized per drug molecule by ADA and NAb status. |
Up to 5 Years
|
|
Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
Tidsram: Up to 5 Years
|
Immunogenicity will be characterized per drug molecule by ADA and NAb status. |
Up to 5 Years
|
|
Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Tidsram: Up to 5 Year
|
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome. |
Up to 5 Year
|
|
PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)
Tidsram: Up to 5 Years
|
The EQ-5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. |
Up to 5 Years
|
|
PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma
Tidsram: Up to 5 Years
|
The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-M is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL). |
Up to 5 Years
|
|
PRO for adults as determined by the Patient Global Impressions Scale (PGIS)
Tidsram: Up to 5 Years
|
The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe". |
Up to 5 Years
|
|
PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC)
Tidsram: Up to 5 Years
|
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change". |
Up to 5 Years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Clinical Trial Management, Regeneron Pharmaceuticals
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R3767-ONC-2055
- 2022-501576-25-00 (Registeridentifierare: EUCT Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
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