완전 절제된 고위험 피부암을 가진 성인 및 청소년 환자에서 Pembrolizumab 대비 Fianlimab 및 Cemiplimab 병용의 우월성을 평가하기 위한 연구
완전히 절제된 고위험 흑색종 환자의 보조제 설정에서 Fianlimab(Anti-LAG-3) 및 Cemiplimab 대 Pembrolizumab의 3상 시험
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Batumi, 그루지야, 6000
- Cancer Center of Adjara
-
Tbilisi, 그루지야, 0159
- JSC K. Eristavi National Center of Experimental and Clinical Surgery
-
Tbilisi, 그루지야, 0114
- LTD New Hospitals
-
Tbilisi, 그루지야, 0112
- Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
-
Tbilisi, 그루지야, 0112
- Israeli Georgian Medical Research Clinic Helsicore
-
Tbilisi, 그루지야, 0160
- TIM - Tbilisi Institute of Medicine
-
-
Caucasus
-
Tbilisi, Caucasus, 그루지야, 0144
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
-
-
-
-
-
Thessaloniki, 그리스, 57001
- Interbalkan Medical Center
-
Thessaloniki, 그리스, 54007
- Ongology Theageneio Thessaloniki
-
Thessaloniki, 그리스, 54622
- BioClinic Thessaloniki
-
-
Attica
-
Athens, Attica, 그리스, 11527
- National and Kapodistrian University of Athens
-
Neo Faliro, Attica, 그리스, 18547
- Metropolitan Hospital
-
-
-
-
Gauteng
-
Johannesburg, Gauteng, 남아프리카, 2196
- The Medical Oncology Centre of Rosebank
-
Pretoria, Gauteng, 남아프리카, 0081
- Wilgers Oncology Centre
-
-
Western Cape
-
Cape Town, Western Cape, 남아프리카, 7925
- Groote Schuur Hospital
-
Kraaifontein, Western Cape, 남아프리카, 7570
- Cape Town Oncology Trials
-
-
-
-
-
Berlin, 독일, 10117
- Charite Universitaetsmedizin Berlin
-
Bremen, 독일, 28325
- Klinikum Bremen Ost
-
-
Baden-Wurttemberg
-
Mannheim, Baden-Wurttemberg, 독일, 68167
- University Medical Center Mannheim
-
Tübingen, Baden-Wurttemberg, 독일, 72076
- University of Tuebingen
-
-
Bavaria
-
Augsburg, Bavaria, 독일, 86179
- University Hospital Augsburg
-
Erlangen, Bavaria, 독일, 91054
- Dermatology Erlangen
-
Munich, Bavaria, 독일, 80337
- LMU Klinikum
-
Regensburg, Bavaria, 독일, 93053
- University Hospital of Regensburg
-
-
Hesse
-
Darmstadt, Hesse, 독일, 64283
- Klinikum Darmstadt GmbH
-
Frankfurt am Main, Hesse, 독일, 60590
- University Clinic Frankfurt
-
-
Lower Saxony
-
Göttingen, Lower Saxony, 독일, 37075
- University Medical Center Goettingen
-
-
Mecklenburg-Vorpommern
-
Schwerin, Mecklenburg-Vorpommern, 독일, 19055
- Helios Kliniken Schwerin
-
-
North Rhine-Westphalia
-
Bochum, North Rhine-Westphalia, 독일, 44791
- Ruhr University Bochum
-
Essen, North Rhine-Westphalia, 독일, 45147
- Universitatsklinikum Essen
-
Münster, North Rhine-Westphalia, 독일, 48157
- Fachklinik Hornheide
-
Münster, North Rhine-Westphalia, 독일, 48149
- University Hospital Muenster
-
-
Rhineland-Palatinate
-
Ludwigshafen am Rhein, Rhineland-Palatinate, 독일, D-67063
- Hautklinik
-
-
Saxony
-
Dresden, Saxony, 독일, 01307
- University Hospital Dresden
-
-
Saxony-Anhalt
-
Quedlinburg, Saxony-Anhalt, 독일, 06484
- Skin Cancer Center Harz
-
-
Schleswig-Holstein
-
Kiel, Schleswig-Holstein, 독일, 24105
- University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel
-
Lübeck, Schleswig-Holstein, 독일, 23538
- Universitatsklinikum Schleswig Holstein Campus Luebeck
-
-
Thuringia
-
Erfurt, Thuringia, 독일, D-99089
- Helios Klinikum Erfurt
-
-
-
-
-
Iași, 루마니아, 700106
- Centrul De Oncologie Euroclinic
-
-
Bucharest
-
Bucharest, Bucharest, 루마니아, 022328
- Institute of Oncology Bucharest
-
-
Cluj
-
Cluj-Napoca, Cluj, 루마니아, 400015
- Cardiomed
-
Cluj-Napoca, Cluj, 루마니아, 400015
- Institute of Oncology Prof. Dr Ion Chirircuta
-
Floreşti, Cluj, 루마니아, 407280
- Radiotherapy Center Cluj
-
-
Dolj
-
Craiova, Dolj, 루마니아, 200347
- Sfantul Nectarie Oncology Center
-
-
Timiș County
-
Timișoara, Timiș County, 루마니아, 300166
- Oncocenter Oncologie Clinica S.R.L
-
Timișoara, Timiș County, 루마니아, 300239
- Oncomed
-
-
-
-
-
Veracruz, 멕시코, 91910
- Faicic Centro de Investigacion Clinica de Veracruz
-
-
Guanajuato
-
León, Guanajuato, 멕시코, 37178
- Preparaciones Oncologica SC
-
-
Jalisco
-
Guadalajara, Jalisco, 멕시코, 44280
- Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
-
Guadalajara, Jalisco, 멕시코, 44670
- Pan American Clinical Research
-
-
Nuevo León
-
Monterrey, Nuevo León, 멕시코, 64710
- iCan Oncology
-
-
Sinaloa
-
Culiacán, Sinaloa, 멕시코, 80020
- Neurociencias Estudios Clinicos SC
-
-
Yucatán
-
Mérida, Yucatán, 멕시코, 97134
- Centro De Atencion E Investigacion Clinica En Oncologia SCP
-
-
-
-
California
-
La Jolla, California, 미국, 92093
- UC San Diego
-
San Francisco, California, 미국, 94158
- UCSF Medical Center at Mission Bay
-
Santa Monica, California, 미국, 90404
- John Wayne Cancer Institute (JWCI)
-
-
Colorado
-
Englewood, Colorado, 미국, 80113
- The Melanoma And Skin Cancer Institute
-
-
Florida
-
Miami, Florida, 미국, 33176
- Miami Cancer Institute at Baptist Health, Inc.
-
Orlando, Florida, 미국, 32806
- Orlando Health
-
Tampa, Florida, 미국, 33612
- Moffitt Cancer Center
-
-
Illinois
-
Chicago, Illinois, 미국, 60611
- Northwestern University
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
-
-
Michigan
-
Detroit, Michigan, 미국, 48201
- Karmanos Cancer Institute
-
-
New Jersey
-
New Brunswick, New Jersey, 미국, 08901
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
New York, New York, 미국, 10032
- Columbia University
-
New York, New York, 미국, 10016
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
-
Rochester, New York, 미국, 14642
- University of Rochester
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국, 27599
- Lineberger Comprehensive Cancer Center
-
Durham, North Carolina, 미국, 27710
- Duke Cancer Institute, University Hospital
-
-
Ohio
-
Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center
-
Columbus, Ohio, 미국, 43210
- The Ohio State University James Comprehensive Cancer Center
-
-
Pennsylvania
-
Easton, Pennsylvania, 미국, 18045
- St Lukes University Health Network
-
Pittsburgh, Pennsylvania, 미국, 15213
- University Of Pittsburgh
-
-
Tennessee
-
Knoxville, Tennessee, 미국, 37920
- University of Tennessee Medical Center
-
Nashville, Tennessee, 미국, 37203-1625
- Tennessee Oncology - Centennial Clinic Location
-
Nashville, Tennessee, 미국, 37203
- Verdi Oncology
-
-
Texas
-
Dallas, Texas, 미국, 75390
- UT Southwestern Medical Center
-
-
Utah
-
Murray, Utah, 미국, 84107
- Intermountain Medical Center
-
-
Virginia
-
Charlottesville, Virginia, 미국, 22903
- University of Virginia Medical Center
-
-
-
-
-
Brussels, 벨기에, 1200
- Cliniques Universitaires Saint-Luc
-
-
Oost-Vlaanderen
-
Sint-Niklaas, Oost-Vlaanderen, 벨기에, 9100
- Vitaz campus Sint-Niklaas Moerland
-
-
West-Vlaanderen
-
Kortrijk, West-Vlaanderen, 벨기에, 8500
- AZ Groeninge
-
-
-
-
-
Rio de Janeiro, 브라질, 23793-080
- Instituto COI
-
São Paulo, 브라질, 01236030
- Hemomed
-
São Paulo, 브라질, 04014-002
- Sao Camilo Oncologia
-
São Paulo, 브라질, 01308-050
- Hospital Sirio Libanes
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, 브라질, 30130-090
- Hospital das Clinicas da Universidade Federal de Minas Gerais
-
-
Paraná
-
Curitiba, Paraná, 브라질, 81520-060
- Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
-
-
Rio Grande do Sul
-
Ijuí, Rio Grande do Sul, 브라질, 98700-000
- Oncosite Centro De Pesquisa Em Oncologia
-
Passo Fundo, Rio Grande do Sul, 브라질, 99010-090
- Instituto do Cancer em Hospital Sao Vicente de Paulo
-
Porto Alegre, Rio Grande do Sul, 브라질, 90035007
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, 브라질, 90619900
- Centro de Pesquisa em Oncologia PUCRS
-
Porto Alegre, Rio Grande do Sul, 브라질, 90440140
- Hospital Moinhos de vento
-
-
Rio de Janeiro
-
Santo Cristo, Rio de Janeiro, 브라질, 20220-410
- INCA Instituto Nacional de Cancer
-
-
Santa Catarina
-
Itajaí, Santa Catarina, 브라질, 88301-220
- Catarina Pesquisa Clinica
-
Joinville, Santa Catarina, 브라질, 89201260
- Instituto Joinvilense de Hematologia e Oncologia
-
Lages, Santa Catarina, 브라질, 88501-001
- Animi Unidade de Tratamento Oncologico
-
-
São Paulo
-
Barretos, São Paulo, 브라질, 14784400
- Fundacao Pio XII - Hospital de Amor
-
Sorocaba, São Paulo, 브라질, 18052-210
- Unimed Sorocaba
-
São José do Rio Preto, São Paulo, 브라질, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
-
-
-
-
-
Barcelona, 스페인, 08036
- Hospital Clinic de Barcelona
-
Barcelona, 스페인, 08908
- Catalan Institute of Oncology (ICO) Hospitalet
-
Barcelona, 스페인, 08035
- Hospital Vall d'Hebron
-
Granada, 스페인, 18014
- Hospital Universitario Virgen de las Nieves
-
Lugo, 스페인, 27003
- Hospital Universitario Lucus Augusti
-
Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
-
Madrid, 스페인, 28046
- Hospital Universitario La Pa<
-
Madrid, 스페인, 28050
- Centro Integral Oncologico HM Clara Campal
-
Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Maranon
-
Seville, 스페인, 41009
- Hospital Universitario Virgen Macarena
-
Valencia, 스페인, 46010
- Incliva - Instituto de Investigacion Sanitaria
-
Valencia, 스페인, 46009
- Instituto Valenciano de Oncologia
-
-
Barcelona
-
Badalona, Barcelona, 스페인, 08916
- H. Germans Trias i Pujol, ICO-Badalona
-
-
Cantabria
-
Santander, Cantabria, 스페인, 39008
- Hospital Universitario Marques de Valdecilla
-
-
Catalonia
-
Barcelona, Catalonia, 스페인, 08028
- Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, 스페인, 33011
- Hospital Universitario Central De Asturias
-
-
-
-
-
Caba, 아르헨티나, 1061
- DIABAID - Instituto de Asistencia Integral en Diabetes
-
-
Buenos Aires
-
Caba, Buenos Aires, 아르헨티나, 1125
- Fundacion Centro de Investigaciones para la Transformacion (CENIT)
-
Pergamino, Buenos Aires, 아르헨티나, B2700CPM
- Centro de Investigacion Pergamino
-
-
Río Negro Province
-
Viedma, Río Negro Province, 아르헨티나, 8500
- Clinica Viedma S.A.
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, 아르헨티나, S2000KZE
- Instituto de Oncologia de Rosario
-
-
Tucumán Province
-
San Miguel de Tucumán, Tucumán Province, 아르헨티나, 4000
- Centro Medico San Roque
-
-
-
-
-
Cork, 아일랜드, T12 EC8P
- Cork University Hospital
-
Dublin, 아일랜드, D09 V2N0
- Beaumont Hospital
-
Dublin, 아일랜드, DO4YN63
- St Vincents University Hospital
-
-
Connacht
-
Galway, Connacht, 아일랜드, H91 YR71
- Galway University Hospital
-
-
-
-
-
London, 영국, NW1 2PG
- University College London Hospitals
-
London, 영국, EC1A 7BE
- Saint Bartholomew's Hospital
-
Manchester, 영국, M20 4BX
- The Christie
-
Taunton, 영국, TA1 5DA
- Taunton and Somerset NHS Foundation Trust
-
-
Devon
-
Exeter, Devon, 영국, EX2 5DW
- Royal Devon and Exeter Hospital NHS Trust
-
-
Lothian
-
Edinburgh, Lothian, 영국, EH4 2XU
- Edinburgh Cancer Centre
-
-
Somerset
-
Bristol, Somerset, 영국, BS2 8ED
- Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
-
-
Surrey
-
Sutton, Surrey, 영국, SM2 5PT
- The Royal Marsden NHS Foundation Trust
-
-
West Midlands
-
Coventry, West Midlands, 영국, CV2 2DX
- University Hospital Coventry and Warwickshire Nhs Trust
-
-
-
-
-
Jerusalem, 이스라엘, 91120
- Hadassah Medical Organization
-
Tel HaShomer, 이스라엘, 5265601
- Sheba Medical Center
-
-
Northern District
-
Afula, Northern District, 이스라엘, 18340000
- Haemek Medical Center
-
-
-
-
-
Bari, 이탈리아, 70124
- Istituto dei Tumori
-
Cuneo, 이탈리아, 12100
- Azienda Ospedaliera Santa Croce i Carle
-
Milan, 이탈리아, 20141
- Istituto Europeo di Oncologia
-
Naples, 이탈리아, 80131
- Instituto Nazionale Tumori Fondazione Giovanni Pascale
-
Perugia, 이탈리아, 06132
- University of Perugia
-
Rome, 이탈리아, 000168
- Fondazione Policlinico Universitrio a. Gemelli - IRCCS
-
Rome, 이탈리아, 00128
- Campus Bio-Medico di Roma
-
Rome, 이탈리아, 00167
- Istituto Dermopatico dell'Immacolata
-
Trento, 이탈리아, 38122
- Santa Chiara Hospital
-
Udine, 이탈리아, 33100
- Azienda Sanitaria Universitaria del Friuli Centrale
-
-
An
-
Ancona, An, 이탈리아, 60020
- Clinica Oncologica, AOU Riuniti Ancona
-
-
Campania
-
Naples, Campania, 이탈리아, 80121
- U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)
-
-
Forli Cesena
-
Meldola, Forli Cesena, 이탈리아, 47014
- Istituto Romagnolo per lo Studio dei Tumori (IRST)
-
-
Lombardy
-
Milan, Lombardy, 이탈리아, 20089
- Istituto Clinico Humanitas
-
-
-
-
-
Ostrava, 체코, 70852
- University Hospital Ostrava
-
-
Brno Mesto
-
Brno, Brno Mesto, 체코, 65653
- Masaryk Memorial Cancer Institute
-
-
North Central Czech Republic
-
Hradec Králové, North Central Czech Republic, 체코, 50005
- University Hospital Hradec Kralove
-
-
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, 칠레, 7560907
- Centro Oncologia de Precision Universidad Mayor
-
Santiago, Santiago Metropolitan, 칠레, 7550000
- Clinica UC San Carlos de Apoquindo
-
-
Valparaiso
-
Viña del Mar, Valparaiso, 칠레, 2520598
- Oncocentro APYS
-
-
-
-
New Brunswick
-
Fredericton, New Brunswick, 캐나다, E3B 5N5
- Dr. Everett Chalmers Hospital
-
-
Ontario
-
Barrie, Ontario, 캐나다, L4M 6M2
- Royal Victoria Regional Health Centre
-
Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Cancer Centre
-
Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
-
-
-
Ankara, 터키 (Türkiye), 06100
- Ozel Liv Hospital
-
Ankara, 터키 (Türkiye), 0906520
- Memorial Ankara Hospital
-
Ankara, 터키 (Türkiye), 06100
- Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
-
Ankara, 터키 (Türkiye), 06010
- Gulhane Research And Training Hospital
-
Edirne, 터키 (Türkiye), 22030
- Trakya University
-
Istanbul, 터키 (Türkiye), 34450
- Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
-
Istanbul, 터키 (Türkiye), 81450
- Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
-
-
Adana
-
Yüreğir, Adana, 터키 (Türkiye), 01230
- Baskent University
-
-
Diyarbakır
-
Sur, Diyarbakır, 터키 (Türkiye), 21200
- Dicle University - Medical Faculty Campus
-
-
Kocaeli
-
İzmit, Kocaeli, 터키 (Türkiye), 41380
- Kocaeli University
-
-
Sehitkamil
-
Gaziantep, Sehitkamil, 터키 (Türkiye), 27584
- Gaziantep Medicalpoint Hospital
-
-
-
-
Mazxowieckie
-
Siedlce, Mazxowieckie, 폴란드, 08-110
- Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, 폴란드, 80-214
- UCK
-
Gdansk, Pomeranian Voivodeship, 폴란드, 80-219
- Copernicus Podmiot Leczniczy Sp. z o.o.Wojewodzie Centrum Onkologii
-
Słupsk, Pomeranian Voivodeship, 폴란드, 76-200
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
-
-
Wielkopolska
-
Poznan, Wielkopolska, 폴란드, 60-788
- Poznan University of Meidcla Science
-
-
-
-
-
Avignon, 프랑스, 84918
- Sainte Catherine Institut du Cancer Avignon Provence
-
Boulogne-Billancourt, 프랑스, 92100
- N_Hôpital Ambroise-Paré
-
Clermont-Ferrand, 프랑스, 63003
- CHU Estaing
-
Nice, 프랑스, 06202
- Centre Hospitalier Universitaire De Nice Hopital De L Archet
-
Valence, 프랑스, 26000
- Centre Hospitalier de Valence
-
Villejuif, 프랑스, 94805
- Institut Gustave Roussy
-
-
Bourgogne-Franche-Comté
-
Dijon, Bourgogne-Franche-Comté, 프랑스, 21000
- Centre Georges Francois Leclerc
-
-
Burgundy
-
Dijon, Burgundy, 프랑스, 21000
- CHU-Dijon
-
-
Doubs
-
Besançon, Doubs, 프랑스, 25000
- Besancon Regional University Hospital Center
-
-
Gironde
-
Bordeaux, Gironde, 프랑스, 33075
- Chu De Bordeaux
-
-
Haute-Garonne
-
Toulouse, Haute-Garonne, 프랑스, 31059
- Institut Claudius Regaud, IUCT-Oncopole
-
-
Hauts-de-France
-
Lille, Hauts-de-France, 프랑스, 59000
- CHU de Lille
-
-
Herault
-
Montpellier, Herault, 프랑스, 34295
- Service de Dermatologie CHU Saint Eloi
-
-
Isere
-
La Tronche, Isere, 프랑스, 38700
- Centre Hospitalier Universitaire Grenoble Alpes
-
-
Normandy
-
Caen, Normandy, 프랑스, 14076
- Centre Francois Baclesse (CFB)
-
-
Pays de la Loire Region
-
Le Mans, Pays de la Loire Region, 프랑스, 72037
- Centre Hospitalier Le Mans
-
Nantes, Pays de la Loire Region, 프랑스, 44093
- Nantes University Hospital
-
-
Picardie
-
Amiens, Picardie, 프랑스, 80000
- CHU Amiens-Picardie
-
-
Île-de-France Region
-
Bobigny, Île-de-France Region, 프랑스, 93000
- Hopital Avicenne
-
Créteil, Île-de-France Region, 프랑스, 94000
- Hospital Henri Mondor
-
Paris, Île-de-France Region, 프랑스, 75010
- Saint Louis Hospital
-
-
-
-
New South Wales
-
Blacktown, New South Wales, 호주, 2148
- Blacktown Cancer and Haematology Centre - Blacktown Hospital
-
Lismore, New South Wales, 호주, 2480
- Lismore Base Hospital
-
Liverpool, New South Wales, 호주, 2170
- Liverpool Hospital - Cancer Therapy Centre
-
Wollstonecraft, New South Wales, 호주, 2065
- Melanoma Institute of Australia
-
-
South Australia
-
Bedford Park, South Australia, 호주, 5042
- Flinders Medical Centre
-
North Adelaide, South Australia, 호주, 5006
- Calvary North Adelaide Hospital
-
-
Victoria
-
Box Hill, Victoria, 호주, 3128
- Eastern Health
-
Geelong, Victoria, 호주, 3220
- Andrew Love Cancer Centre
-
Melbourne, Victoria, 호주, 3004
- Alfred Hospital
-
-
Western Australia
-
Nedlands, Western Australia, 호주, 6009
- One Clinical Research at Hollywood Private Hospital
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
Cemiplimab will be administered by IV infusion Q 3 weeks
다른 이름들:
|
|
실험적: 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
다른 이름들:
Cemiplimab will be administered by IV infusion Q 3 weeks
다른 이름들:
|
|
활성 비교기: 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
다른 이름들:
Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Relapse free survival (RSF)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
EORTC QLQ-C30에 따른 글로벌 건강 상태/삶의 질 저하까지의 시간
기간: 최대 5년
|
최대 5년
|
|
|
EORTC QLQ-C30에 따른 신체 기능 저하까지의 시간
기간: 최대 5년
|
최대 5년
|
|
|
EORTC QLQ-C30에 따른 역할 기능 저하 시간
기간: 최대 5년
|
최대 5년
|
|
|
Distant metastasis-free survival (DMFS)
기간: 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)
기간: Up to 5 Years
|
Time from randomization to the date of death. |
Up to 5 Years
|
|
Occurrence of treatment-emergent adverse events (TEAEs)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- R3767-ONC-2055
- 2022-501576-25-00 (레지스트리 식별자: EUCT Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .