Eine Studie zur Bewertung der Überlegenheit der Kombination aus Fianlimab und Cemiplimab im Vergleich zu Pembrolizumab bei erwachsenen und jugendlichen Patienten mit vollständig reseziertem Hochrisiko-Hautkrebs
9. November 2026 aktualisiert von: Regeneron Pharmaceuticals
Eine Phase-3-Studie mit Fianlimab (Anti-LAG-3) und Cemiplimab versus Pembrolizumab im adjuvanten Setting bei Patienten mit vollständig reseziertem Hochrisiko-Melanom
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.
Studienübersicht
Status
Status
Aktiv, nicht rekrutierend
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Interventionell
Einschreibung (Tatsächlich)
Einschreibung
1564
Phase
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Caba, Argentinien, 1061
- DIABAID - Instituto de Asistencia Integral en Diabetes
-
-
Buenos Aires
-
Caba, Buenos Aires, Argentinien, 1125
- Fundacion Centro de Investigaciones para la Transformacion (CENIT)
-
Pergamino, Buenos Aires, Argentinien, B2700CPM
- Centro de Investigacion Pergamino
-
-
Río Negro Province
-
Viedma, Río Negro Province, Argentinien, 8500
- Clinica Viedma S.A.
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentinien, S2000KZE
- Instituto de Oncologia de Rosario
-
-
Tucumán Province
-
San Miguel de Tucumán, Tucumán Province, Argentinien, 4000
- Centro Medico San Roque
-
-
-
-
New South Wales
-
Blacktown, New South Wales, Australien, 2148
- Blacktown Cancer and Haematology Centre - Blacktown Hospital
-
Lismore, New South Wales, Australien, 2480
- Lismore Base Hospital
-
Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital - Cancer Therapy Centre
-
Wollstonecraft, New South Wales, Australien, 2065
- Melanoma Institute of Australia
-
-
South Australia
-
Bedford Park, South Australia, Australien, 5042
- Flinders Medical Centre
-
North Adelaide, South Australia, Australien, 5006
- Calvary North Adelaide Hospital
-
-
Victoria
-
Box Hill, Victoria, Australien, 3128
- Eastern Health
-
Geelong, Victoria, Australien, 3220
- Andrew Love Cancer Centre
-
Melbourne, Victoria, Australien, 3004
- Alfred Hospital
-
-
Western Australia
-
Nedlands, Western Australia, Australien, 6009
- One Clinical Research at Hollywood Private Hospital
-
-
-
-
-
Brussels, Belgien, 1200
- Cliniques Universitaires Saint-Luc
-
-
Oost-Vlaanderen
-
Sint-Niklaas, Oost-Vlaanderen, Belgien, 9100
- Vitaz campus Sint-Niklaas Moerland
-
-
West-Vlaanderen
-
Kortrijk, West-Vlaanderen, Belgien, 8500
- AZ Groeninge
-
-
-
-
-
Rio de Janeiro, Brasilien, 23793-080
- Instituto COI
-
São Paulo, Brasilien, 01236030
- Hemomed
-
São Paulo, Brasilien, 04014-002
- Sao Camilo Oncologia
-
São Paulo, Brasilien, 01308-050
- Hospital Sirio Libanes
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brasilien, 30130-090
- Hospital das Clinicas da Universidade Federal de Minas Gerais
-
-
Paraná
-
Curitiba, Paraná, Brasilien, 81520-060
- Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
-
-
Rio Grande do Sul
-
Ijuí, Rio Grande do Sul, Brasilien, 98700-000
- Oncosite Centro De Pesquisa Em Oncologia
-
Passo Fundo, Rio Grande do Sul, Brasilien, 99010-090
- Instituto do Cancer em Hospital Sao Vicente de Paulo
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90035007
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90619900
- Centro de Pesquisa em Oncologia PUCRS
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90440140
- Hospital Moinhos de vento
-
-
Rio de Janeiro
-
Santo Cristo, Rio de Janeiro, Brasilien, 20220-410
- INCA Instituto Nacional de Cancer
-
-
Santa Catarina
-
Itajaí, Santa Catarina, Brasilien, 88301-220
- Catarina Pesquisa Clinica
-
Joinville, Santa Catarina, Brasilien, 89201260
- Instituto Joinvilense de Hematologia e Oncologia
-
Lages, Santa Catarina, Brasilien, 88501-001
- Animi Unidade de Tratamento Oncologico
-
-
São Paulo
-
Barretos, São Paulo, Brasilien, 14784400
- Fundacao Pio XII - Hospital de Amor
-
Sorocaba, São Paulo, Brasilien, 18052-210
- Unimed Sorocaba
-
São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
-
-
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chile, 7560907
- Centro Oncologia de Precision Universidad Mayor
-
Santiago, Santiago Metropolitan, Chile, 7550000
- Clinica UC San Carlos de Apoquindo
-
-
Valparaiso
-
Viña del Mar, Valparaiso, Chile, 2520598
- Oncocentro APYS
-
-
-
-
-
Berlin, Deutschland, 10117
- Charite Universitaetsmedizin Berlin
-
Bremen, Deutschland, 28325
- Klinikum Bremen Ost
-
-
Baden-Wurttemberg
-
Mannheim, Baden-Wurttemberg, Deutschland, 68167
- University Medical Center Mannheim
-
Tübingen, Baden-Wurttemberg, Deutschland, 72076
- University of Tuebingen
-
-
Bavaria
-
Augsburg, Bavaria, Deutschland, 86179
- University Hospital Augsburg
-
Erlangen, Bavaria, Deutschland, 91054
- Dermatology Erlangen
-
Munich, Bavaria, Deutschland, 80337
- LMU Klinikum
-
Regensburg, Bavaria, Deutschland, 93053
- University Hospital of Regensburg
-
-
Hesse
-
Darmstadt, Hesse, Deutschland, 64283
- Klinikum Darmstadt GmbH
-
Frankfurt am Main, Hesse, Deutschland, 60590
- University Clinic Frankfurt
-
-
Lower Saxony
-
Göttingen, Lower Saxony, Deutschland, 37075
- University Medical Center Goettingen
-
-
Mecklenburg-Vorpommern
-
Schwerin, Mecklenburg-Vorpommern, Deutschland, 19055
- Helios Kliniken Schwerin
-
-
North Rhine-Westphalia
-
Bochum, North Rhine-Westphalia, Deutschland, 44791
- Ruhr University Bochum
-
Essen, North Rhine-Westphalia, Deutschland, 45147
- Universitatsklinikum Essen
-
Münster, North Rhine-Westphalia, Deutschland, 48157
- Fachklinik Hornheide
-
Münster, North Rhine-Westphalia, Deutschland, 48149
- University Hospital Muenster
-
-
Rhineland-Palatinate
-
Ludwigshafen am Rhein, Rhineland-Palatinate, Deutschland, D-67063
- Hautklinik
-
-
Saxony
-
Dresden, Saxony, Deutschland, 01307
- University Hospital Dresden
-
-
Saxony-Anhalt
-
Quedlinburg, Saxony-Anhalt, Deutschland, 06484
- Skin Cancer Center Harz
-
-
Schleswig-Holstein
-
Kiel, Schleswig-Holstein, Deutschland, 24105
- University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel
-
Lübeck, Schleswig-Holstein, Deutschland, 23538
- Universitatsklinikum Schleswig Holstein Campus Luebeck
-
-
Thuringia
-
Erfurt, Thuringia, Deutschland, D-99089
- Helios Klinikum Erfurt
-
-
-
-
-
Avignon, Frankreich, 84918
- Sainte Catherine Institut du Cancer Avignon Provence
-
Boulogne-Billancourt, Frankreich, 92100
- N_Hôpital Ambroise-Paré
-
Clermont-Ferrand, Frankreich, 63003
- CHU Estaing
-
Nice, Frankreich, 06202
- Centre Hospitalier Universitaire De Nice Hopital De L Archet
-
Valence, Frankreich, 26000
- Centre Hospitalier de Valence
-
Villejuif, Frankreich, 94805
- Institut Gustave Roussy
-
-
Bourgogne-Franche-Comté
-
Dijon, Bourgogne-Franche-Comté, Frankreich, 21000
- Centre Georges Francois Leclerc
-
-
Burgundy
-
Dijon, Burgundy, Frankreich, 21000
- CHU-Dijon
-
-
Doubs
-
Besançon, Doubs, Frankreich, 25000
- Besancon Regional University Hospital Center
-
-
Gironde
-
Bordeaux, Gironde, Frankreich, 33075
- Chu De Bordeaux
-
-
Haute-Garonne
-
Toulouse, Haute-Garonne, Frankreich, 31059
- Institut Claudius Regaud, IUCT-Oncopole
-
-
Hauts-de-France
-
Lille, Hauts-de-France, Frankreich, 59000
- CHU de Lille
-
-
Herault
-
Montpellier, Herault, Frankreich, 34295
- Service de Dermatologie CHU Saint Eloi
-
-
Isere
-
La Tronche, Isere, Frankreich, 38700
- Centre Hospitalier Universitaire Grenoble Alpes
-
-
Normandy
-
Caen, Normandy, Frankreich, 14076
- Centre Francois Baclesse (CFB)
-
-
Pays de la Loire Region
-
Le Mans, Pays de la Loire Region, Frankreich, 72037
- Centre Hospitalier Le Mans
-
Nantes, Pays de la Loire Region, Frankreich, 44093
- Nantes University Hospital
-
-
Picardie
-
Amiens, Picardie, Frankreich, 80000
- CHU Amiens-Picardie
-
-
Île-de-France Region
-
Bobigny, Île-de-France Region, Frankreich, 93000
- Hopital Avicenne
-
Créteil, Île-de-France Region, Frankreich, 94000
- Hospital Henri Mondor
-
Paris, Île-de-France Region, Frankreich, 75010
- Saint Louis Hospital
-
-
-
-
-
Batumi, Georgia, 6000
- Cancer Center of Adjara
-
Tbilisi, Georgia, 0159
- JSC K. Eristavi National Center of Experimental and Clinical Surgery
-
Tbilisi, Georgia, 0114
- LTD New Hospitals
-
Tbilisi, Georgia, 0112
- Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
-
Tbilisi, Georgia, 0112
- Israeli Georgian Medical Research Clinic Helsicore
-
Tbilisi, Georgia, 0160
- TIM - Tbilisi Institute of Medicine
-
-
Caucasus
-
Tbilisi, Caucasus, Georgia, 0144
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
-
-
-
-
-
Thessaloniki, Griechenland, 57001
- Interbalkan Medical Center
-
Thessaloniki, Griechenland, 54007
- Ongology Theageneio Thessaloniki
-
Thessaloniki, Griechenland, 54622
- BioClinic Thessaloniki
-
-
Attica
-
Athens, Attica, Griechenland, 11527
- National and Kapodistrian University of Athens
-
Neo Faliro, Attica, Griechenland, 18547
- Metropolitan Hospital
-
-
-
-
-
Cork, Irland, T12 EC8P
- Cork University Hospital
-
Dublin, Irland, D09 V2N0
- Beaumont Hospital
-
Dublin, Irland, DO4YN63
- St Vincents University Hospital
-
-
Connacht
-
Galway, Connacht, Irland, H91 YR71
- Galway University Hospital
-
-
-
-
-
Jerusalem, Israel, 91120
- Hadassah Medical Organization
-
Tel HaShomer, Israel, 5265601
- Sheba Medical Center
-
-
Northern District
-
Afula, Northern District, Israel, 18340000
- Haemek Medical Center
-
-
-
-
-
Bari, Italien, 70124
- Istituto dei Tumori
-
Cuneo, Italien, 12100
- Azienda Ospedaliera Santa Croce i Carle
-
Milan, Italien, 20141
- Istituto Europeo di Oncologia
-
Naples, Italien, 80131
- Instituto Nazionale Tumori Fondazione Giovanni Pascale
-
Perugia, Italien, 06132
- University of Perugia
-
Rome, Italien, 000168
- Fondazione Policlinico Universitrio a. Gemelli - IRCCS
-
Rome, Italien, 00128
- Campus Bio-Medico di Roma
-
Rome, Italien, 00167
- Istituto Dermopatico dell'Immacolata
-
Trento, Italien, 38122
- Santa Chiara Hospital
-
Udine, Italien, 33100
- Azienda Sanitaria Universitaria del Friuli Centrale
-
-
An
-
Ancona, An, Italien, 60020
- Clinica Oncologica, AOU Riuniti Ancona
-
-
Campania
-
Naples, Campania, Italien, 80121
- U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)
-
-
Forli Cesena
-
Meldola, Forli Cesena, Italien, 47014
- Istituto Romagnolo per lo Studio dei Tumori (IRST)
-
-
Lombardy
-
Milan, Lombardy, Italien, 20089
- Istituto Clinico Humanitas
-
-
-
-
New Brunswick
-
Fredericton, New Brunswick, Kanada, E3B 5N5
- Dr. Everett Chalmers Hospital
-
-
Ontario
-
Barrie, Ontario, Kanada, L4M 6M2
- Royal Victoria Regional Health Centre
-
Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Cancer Centre
-
Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
-
-
-
Veracruz, Mexiko, 91910
- Faicic Centro de Investigacion Clinica de Veracruz
-
-
Guanajuato
-
León, Guanajuato, Mexiko, 37178
- Preparaciones Oncologica SC
-
-
Jalisco
-
Guadalajara, Jalisco, Mexiko, 44280
- Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
-
Guadalajara, Jalisco, Mexiko, 44670
- Pan American Clinical Research
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexiko, 64710
- iCan Oncology
-
-
Sinaloa
-
Culiacán, Sinaloa, Mexiko, 80020
- Neurociencias Estudios Clinicos SC
-
-
Yucatán
-
Mérida, Yucatán, Mexiko, 97134
- Centro De Atencion E Investigacion Clinica En Oncologia SCP
-
-
-
-
Mazxowieckie
-
Siedlce, Mazxowieckie, Polen, 08-110
- Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polen, 80-214
- UCK
-
Gdansk, Pomeranian Voivodeship, Polen, 80-219
- Copernicus Podmiot Leczniczy Sp. z o.o.Wojewodzie Centrum Onkologii
-
Słupsk, Pomeranian Voivodeship, Polen, 76-200
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
-
-
Wielkopolska
-
Poznan, Wielkopolska, Polen, 60-788
- Poznan University of Meidcla Science
-
-
-
-
-
Iași, Rumänien, 700106
- Centrul De Oncologie Euroclinic
-
-
Bucharest
-
Bucharest, Bucharest, Rumänien, 022328
- Institute of Oncology Bucharest
-
-
Cluj
-
Cluj-Napoca, Cluj, Rumänien, 400015
- Cardiomed
-
Cluj-Napoca, Cluj, Rumänien, 400015
- Institute of Oncology Prof. Dr Ion Chirircuta
-
Floreşti, Cluj, Rumänien, 407280
- Radiotherapy Center Cluj
-
-
Dolj
-
Craiova, Dolj, Rumänien, 200347
- Sfantul Nectarie Oncology Center
-
-
Timiș County
-
Timișoara, Timiș County, Rumänien, 300166
- Oncocenter Oncologie Clinica S.R.L
-
Timișoara, Timiș County, Rumänien, 300239
- Oncomed
-
-
-
-
-
Barcelona, Spanien, 08036
- Hospital Clinic de Barcelona
-
Barcelona, Spanien, 08908
- Catalan Institute of Oncology (ICO) Hospitalet
-
Barcelona, Spanien, 08035
- Hospital Vall d'Hebron
-
Granada, Spanien, 18014
- Hospital Universitario Virgen de las Nieves
-
Lugo, Spanien, 27003
- Hospital Universitario Lucus Augusti
-
Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
-
Madrid, Spanien, 28046
- Hospital Universitario La Pa<
-
Madrid, Spanien, 28050
- Centro Integral Oncologico HM Clara Campal
-
Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Maranon
-
Seville, Spanien, 41009
- Hospital Universitario Virgen Macarena
-
Valencia, Spanien, 46010
- Incliva - Instituto de Investigacion Sanitaria
-
Valencia, Spanien, 46009
- Instituto Valenciano de Oncologia
-
-
Barcelona
-
Badalona, Barcelona, Spanien, 08916
- H. Germans Trias i Pujol, ICO-Badalona
-
-
Cantabria
-
Santander, Cantabria, Spanien, 39008
- Hospital Universitario Marques de Valdecilla
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 08028
- Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, Spanien, 33011
- Hospital Universitario Central De Asturias
-
-
-
-
Gauteng
-
Johannesburg, Gauteng, Südafrika, 2196
- The Medical Oncology Centre of Rosebank
-
Pretoria, Gauteng, Südafrika, 0081
- Wilgers Oncology Centre
-
-
Western Cape
-
Cape Town, Western Cape, Südafrika, 7925
- Groote Schuur Hospital
-
Kraaifontein, Western Cape, Südafrika, 7570
- Cape Town Oncology Trials
-
-
-
-
-
Ostrava, Tschechien, 70852
- University Hospital Ostrava
-
-
Brno Mesto
-
Brno, Brno Mesto, Tschechien, 65653
- Masaryk Memorial Cancer Institute
-
-
North Central Czech Republic
-
Hradec Králové, North Central Czech Republic, Tschechien, 50005
- University Hospital Hradec Kralove
-
-
-
-
-
Ankara, Türkei (türkiye), 06100
- Ozel Liv Hospital
-
Ankara, Türkei (türkiye), 0906520
- Memorial Ankara Hospital
-
Ankara, Türkei (türkiye), 06100
- Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
-
Ankara, Türkei (türkiye), 06010
- Gulhane Research And Training Hospital
-
Edirne, Türkei (türkiye), 22030
- Trakya University
-
Istanbul, Türkei (türkiye), 34450
- Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
-
Istanbul, Türkei (türkiye), 81450
- Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
-
-
Adana
-
Yüreğir, Adana, Türkei (türkiye), 01230
- Baskent University
-
-
Diyarbakır
-
Sur, Diyarbakır, Türkei (türkiye), 21200
- Dicle University - Medical Faculty Campus
-
-
Kocaeli
-
İzmit, Kocaeli, Türkei (türkiye), 41380
- Kocaeli University
-
-
Sehitkamil
-
Gaziantep, Sehitkamil, Türkei (türkiye), 27584
- Gaziantep Medicalpoint Hospital
-
-
-
-
California
-
La Jolla, California, Vereinigte Staaten, 92093
- UC San Diego
-
San Francisco, California, Vereinigte Staaten, 94158
- UCSF Medical Center at Mission Bay
-
Santa Monica, California, Vereinigte Staaten, 90404
- John Wayne Cancer Institute (JWCI)
-
-
Colorado
-
Englewood, Colorado, Vereinigte Staaten, 80113
- The Melanoma And Skin Cancer Institute
-
-
Florida
-
Miami, Florida, Vereinigte Staaten, 33176
- Miami Cancer Institute at Baptist Health, Inc.
-
Orlando, Florida, Vereinigte Staaten, 32806
- Orlando Health
-
Tampa, Florida, Vereinigte Staaten, 33612
- Moffitt Cancer Center
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60611
- Northwestern University
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
-
-
Michigan
-
Detroit, Michigan, Vereinigte Staaten, 48201
- Karmanos Cancer Institute
-
-
New Jersey
-
New Brunswick, New Jersey, Vereinigte Staaten, 08901
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
New York, New York, Vereinigte Staaten, 10032
- Columbia University
-
New York, New York, Vereinigte Staaten, 10016
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
-
Rochester, New York, Vereinigte Staaten, 14642
- University of Rochester
-
-
North Carolina
-
Chapel Hill, North Carolina, Vereinigte Staaten, 27599
- Lineberger Comprehensive Cancer Center
-
Durham, North Carolina, Vereinigte Staaten, 27710
- Duke Cancer Institute, University Hospital
-
-
Ohio
-
Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Vereinigte Staaten, 44106
- University Hospitals Cleveland Medical Center
-
Columbus, Ohio, Vereinigte Staaten, 43210
- The Ohio State University James Comprehensive Cancer Center
-
-
Pennsylvania
-
Easton, Pennsylvania, Vereinigte Staaten, 18045
- St Lukes University Health Network
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- University Of Pittsburgh
-
-
Tennessee
-
Knoxville, Tennessee, Vereinigte Staaten, 37920
- University of Tennessee Medical Center
-
Nashville, Tennessee, Vereinigte Staaten, 37203-1625
- Tennessee Oncology - Centennial Clinic Location
-
Nashville, Tennessee, Vereinigte Staaten, 37203
- Verdi Oncology
-
-
Texas
-
Dallas, Texas, Vereinigte Staaten, 75390
- UT Southwestern Medical Center
-
-
Utah
-
Murray, Utah, Vereinigte Staaten, 84107
- Intermountain Medical Center
-
-
Virginia
-
Charlottesville, Virginia, Vereinigte Staaten, 22903
- University of Virginia Medical Center
-
-
-
-
-
London, Vereinigtes Königreich, NW1 2PG
- University College London Hospitals
-
London, Vereinigtes Königreich, EC1A 7BE
- Saint Bartholomew's Hospital
-
Manchester, Vereinigtes Königreich, M20 4BX
- The Christie
-
Taunton, Vereinigtes Königreich, TA1 5DA
- Taunton and Somerset NHS Foundation Trust
-
-
Devon
-
Exeter, Devon, Vereinigtes Königreich, EX2 5DW
- Royal Devon and Exeter Hospital NHS Trust
-
-
Lothian
-
Edinburgh, Lothian, Vereinigtes Königreich, EH4 2XU
- Edinburgh Cancer Centre
-
-
Somerset
-
Bristol, Somerset, Vereinigtes Königreich, BS2 8ED
- Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
-
-
Surrey
-
Sutton, Surrey, Vereinigtes Königreich, SM2 5PT
- The Royal Marsden NHS Foundation Trust
-
-
West Midlands
-
Coventry, West Midlands, Vereinigtes Königreich, CV2 2DX
- University Hospital Coventry and Warwickshire Nhs Trust
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
12 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Anzahl der Arme
3
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: 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
Andere Namen:
Cemiplimab will be administered by IV infusion Q 3 weeks
Andere Namen:
|
|
Experimental: 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
Andere Namen:
Cemiplimab will be administered by IV infusion Q 3 weeks
Andere Namen:
|
|
Aktiver 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
Andere Namen:
Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Relapse free survival (RSF)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Zeit bis zur Verschlechterung des globalen Gesundheitszustands/der Lebensqualität gemäß EORTC QLQ-C30
Zeitfenster: Bis zu 5 Jahre
|
Bis zu 5 Jahre
|
|
|
Zeit bis zur Verschlechterung der körperlichen Funktion gemäß EORTC QLQ-C30
Zeitfenster: Bis zu 5 Jahre
|
Bis zu 5 Jahre
|
|
|
Zeit bis zur Verschlechterung der Rollenfunktion gemäß EORTC QLQ-C30
Zeitfenster: Bis zu 5 Jahre
|
Bis zu 5 Jahre
|
|
|
Distant metastasis-free survival (DMFS)
Zeitfenster: 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)
Zeitfenster: Up to 5 Years
|
Time from randomization to the date of death. |
Up to 5 Years
|
|
Occurrence of treatment-emergent adverse events (TEAEs)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Sponsor
Ermittler
Ermittler
- Studienleiter: Clinical Trial Management, Regeneron Pharmaceuticals
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
16. Januar 2023
Primärer Abschluss (Geschätzt)
Primärer Abschluss
15. Januar 2027
Studienabschluss (Geschätzt)
Studienabschluss
3. April 2030
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
14. Oktober 2022
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. Oktober 2022
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
8. November 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
10. November 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. November 2026
Zuletzt verifiziert
Zuletzt verifiziert
1. November 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Neubildungen nach histologischem Typ
- Hautkrankheiten
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Neuroendokrine Tumoren
- Nävi und Melanome
- Haut- und Bindegewebserkrankungen
- Melanom
- Hauttumoren
- Pembrolizumab
- Cemiplimab
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- R3767-ONC-2055
- 2022-501576-25-00 (Registrierungskennung: EUCT Number)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-Sharing-Zeitrahmen
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-Sharing-Zugriffskriterien
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
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .