A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,564

Participants

Timeline

Start Date

January 16, 2023

Primary Completion Date

May 16, 2028

Study Completion Date

February 15, 2030

Conditions
Melanoma
Interventions
DRUG

Fianlimab

Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks

DRUG

Cemiplimab

Cemiplimab will be administered by IV infusion Q 3 weeks

DRUG

Pembrolizumab

Pembrolizumab will be administered by IV infusion Q 3 weeks

DRUG

Placebo

Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks

Trial Locations (211)

1061

DIABAID - Instituto de Asistencia Integral en Diabetes, Caba

1125

Fundacion Centro de Investigaciones para la Transformacion (CENIT), Caba

1200

Cliniques Universitaires Saint-Luc, Brussels

2065

Melanoma Institute of Australia, Wollstonecraft

2148

Blacktown Cancer and Haematology Centre - Blacktown Hospital, Blacktown

2170

Liverpool Hospital - Cancer Therapy Centre, Liverpool

2196

The Medical Oncology Centre of Rosebank, Johannesburg

2480

Lismore Base Hospital, Lismore

3004

Alfred Hospital, Melbourne

3128

Eastern Health, Box Hill

3220

Andrew Love Cancer Centre, Geelong

4000

Centro Medico San Roque, San Miguel de Tucumán

5006

Calvary North Adelaide Hospital, North Adelaide

5042

Flinders Medical Centre, Bedford Park

6000

Cancer Center of Adjara, Batumi

6009

One Clinical Research at Hollywood Private Hospital, Nedlands

7570

Cape Town Oncology Trials, Kraaifontein

7925

Groote Schuur Hospital, Cape Town

8500

Clinica Viedma S.A., Viedma

AZ Groeninge, Kortrijk

9100

Vitaz campus Sint-Niklaas Moerland, Sint-Niklaas

10016

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York

10032

Columbia University, New York

10117

Charite Universitaetsmedizin Berlin, Berlin

11527

National and Kapodistrian University of Athens, Athens

12100

Azienda Ospedaliera Santa Croce i Carle, Cuneo

14076

Centre Francois Baclesse (CFB), Caen

14642

University of Rochester, Rochester

15213

University Of Pittsburgh, Pittsburgh

18014

Hospital Universitario Virgen de las Nieves, Granada

18045

St Lukes University Health Network, Easton

18547

Metropolitan Hospital, Neo Faliro

19055

Helios Kliniken Schwerin, Schwerin

20089

Istituto Clinico Humanitas, Milan

20141

Istituto Europeo di Oncologia, Milan

21000

Centre Georges Francois Leclerc, Dijon

CHU-Dijon, Dijon

21200

Dicle University - Medical Faculty Campus, Sur

22030

Trakya University, Edirne

22903

University of Virginia Medical Center, Charlottesville

23538

Universitatsklinikum Schleswig Holstein Campus Luebeck, Lübeck

24105

University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel, Kiel

25000

Besancon Regional University Hospital Center, Besançon

26000

Centre Hospitalier de Valence, Valence

27003

Hospital Universitario Lucus Augusti, Lugo

27584

Gaziantep Medicalpoint Hospital, Gaziantep

27599

Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke Cancer Institute, University Hospital, Durham

28007

Hospital General Universitario Gregorio Maranon, Madrid

28041

Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM, Madrid

28046

Hospital Universitario La Pa<, Madrid

28050

Centro Integral Oncologico HM Clara Campal, Madrid

28325

Klinikum Bremen Ost, Bremen

31059

Institut Claudius Regaud, IUCT-Oncopole, Toulouse

32806

Orlando Health, Orlando

33011

Hospital Universitario Central De Asturias, Oviedo

33075

Chu De Bordeaux, Bordeaux

33100

Azienda Sanitaria Universitaria del Friuli Centrale, Udine

33176

Miami Cancer Institute at Baptist Health, Inc., Miami

33612

Moffitt Cancer Center, Tampa

34295

Service de Dermatologie CHU Saint Eloi, Montpellier

34450

Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty, Istanbul

37075

University Medical Center Goettingen, Göttingen

37178

Preparaciones Oncologica SC, León

37203

Verdi Oncology, Nashville

37920

University of Tennessee Medical Center, Knoxville

38122

Santa Chiara Hospital, Trento

38700

Centre Hospitalier Universitaire Grenoble Alpes, La Tronche

39008

Hospital Universitario Marques de Valdecilla, Santander

41009

Hospital Universitario Virgen Macarena, Seville

41380

Kocaeli University, İzmit

43210

The Ohio State University James Comprehensive Cancer Center, Columbus

44093

Nantes University Hospital, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44280

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

44670

Pan American Clinical Research, Guadalajara

44791

Ruhr University Bochum, Bochum

45147

Universitatsklinikum Essen, Essen

46009

Instituto Valenciano de Oncologia, Valencia

46010

Incliva - Instituto de Investigacion Sanitaria, Valencia

47014

Istituto Romagnolo per lo Studio dei Tumori (IRST), Meldola

48149

University Hospital Muenster, Münster

48157

Fachklinik Hornheide, Münster

48201

Karmanos Cancer Institute, Detroit

50005

University Hospital Hradec Kralove, Hradec Králové

54007

Ongology Theageneio Thessaloniki, Thessaloniki

54622

BioClinic Thessaloniki, Thessaloniki

57001

Interbalkan Medical Center, Thessaloniki

59000

CHU de Lille, Lille

60020

Clinica Oncologica, AOU Riuniti Ancona, Ancona

60590

University Clinic Frankfurt, Frankfurt am Main

60611

Northwestern University, Chicago

63003

CHU Estaing, Clermont-Ferrand

64283

Klinikum Darmstadt GmbH, Darmstadt

64710

iCan Oncology, Monterrey

65653

Masaryk Memorial Cancer Institute, Brno

68167

University Medical Center Mannheim, Mannheim

70124

Istituto dei Tumori, Bari

70852

University Hospital Ostrava, Ostrava

72037

Centre Hospitalier Le Mans, Le Mans

72076

University of Tuebingen, Tübingen

75010

Saint Louis Hospital, Paris

75390

UT Southwestern Medical Center, Dallas

80000

CHU Amiens-Picardie, Amiens

80020

Neurociencias Estudios Clinicos SC, Culiacán

80113

The Melanoma And Skin Cancer Institute, Englewood

80121

U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology), Naples

80131

Instituto Nazionale Tumori Fondazione Giovanni Pascale, Naples

80337

LMU Klinikum, Munich

81450

Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital, Istanbul

84107

Intermountain Medical Center, Murray

84918

Sainte Catherine Institut du Cancer Avignon Provence, Avignon

86179

University Hospital Augsburg, Augsburg

90404

John Wayne Cancer Institute (JWCI), Santa Monica

91054

Dermatology Erlangen, Erlangen

91120

Hadassah Medical Organization, Jerusalem

91910

Faicic Centro de Investigacion Clinica de Veracruz, Veracruz

92093

UC San Diego, La Jolla

92100

N_Hôpital Ambroise-Paré, Boulogne-Billancourt

93000

Hopital Avicenne, Bobigny

93053

University Hospital of Regensburg, Regensburg

94000

Hospital Henri Mondor, Créteil

94158

UCSF Medical Center at Mission Bay, San Francisco

94805

Institut Gustave Roussy, Villejuif

97134

Centro De Atencion E Investigacion Clinica En Oncologia SCP, Mérida

200347

Sfantul Nectarie Oncology Center, Craiova

300166

Oncocenter Oncologie Clinica S.R.L, Timișoara

300239

Oncomed, Timișoara

400015

Cardiomed, Cluj-Napoca

Institute of Oncology Prof. Dr Ion Chirircuta, Cluj-Napoca

407280

Radiotherapy Center Cluj, Floreşti

700106

Centrul De Oncologie Euroclinic, Iași

2520598

Oncocentro APYS, Viña del Mar

5265601

Sheba Medical Center, Tel Litwinsky

7550000

Clinica UC San Carlos de Apoquindo, Santiago

7560907

Centro Oncologia de Precision Universidad Mayor, Santiago

14784400

Fundacao Pio XII - Hospital de Amor, Barretos

18340000

Haemek Medical Center, Afula

89201260

Instituto Joinvilense de Hematologia e Oncologia, Joinville

90035007

Hospital de Clinicas de Porto Alegre, Porto Alegre

90440140

Hospital Moinhos de vento, Porto Alegre

90619900

Centro de Pesquisa em Oncologia PUCRS, Porto Alegre

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

37203-1625

Tennessee Oncology - Centennial Clinic Location, Nashville

B2700CPM

Centro de Investigacion Pergamino, Pergamino

S2000KZE

Instituto de Oncologia de Rosario, Rosario

30130-090

Hospital das Clinicas da Universidade Federal de Minas Gerais, Belo Horizonte

81520-060

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner, Curitiba

20220-410

INCA Instituto Nacional de Cancer, Santo Cristo

98700-000

Oncosite Centro De Pesquisa Em Oncologia, Ijuí

99010-090

Instituto do Cancer em Hospital Sao Vicente de Paulo, Passo Fundo

88301-220

Catarina Pesquisa Clinica, Itajaí

88501-001

Animi Unidade de Tratamento Oncologico, Lages

15090-000

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base, São José do Rio Preto

18052-210

Unimed Sorocaba, Sorocaba

23793-080

Instituto COI, Rio de Janeiro

01236030

Hemomed, São Paulo

01308-050

Hospital Sirio Libanes, São Paulo

04014-002

Sao Camilo Oncologia, São Paulo

E3B 5N5

Dr. Everett Chalmers Hospital, Fredericton

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

06202

Centre Hospitalier Universitaire De Nice Hopital De L Archet, Nice

0144

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Tbilisi

0112

Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine, Tbilisi

Israeli Georgian Medical Research Clinic Helsicore, Tbilisi

0114

LTD New Hospitals, Tbilisi

0159

JSC K. Eristavi National Center of Experimental and Clinical Surgery, Tbilisi

0160

TIM - Tbilisi Institute of Medicine, Tbilisi

D-67063

Hautklinik, Ludwigshafen am Rhein

01307

University Hospital Dresden, Dresden

06484

Skin Cancer Center Harz, Quedlinburg

D-99089

Helios Klinikum Erfurt, Erfurt

H91 YR71

Galway University Hospital, Galway

T12 EC8P

Cork University Hospital, Cork

D09 V2N0

Beaumont Hospital, Dublin

DO4YN63

St Vincents University Hospital, Dublin

06132

University of Perugia, Perugia

000168

Fondazione Policlinico Universitrio a. Gemelli - IRCCS, Rome

00128

Campus Bio-Medico di Roma, Rome

00167

Istituto Dermopatico dell'Immacolata, Rome

08-110

Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii, Siedlce

80-214

UCK, Gdansk

80-219

Copernicus Podmiot Leczniczy Sp. z o.o.Wojewodzie Centrum Onkologii, Gdansk

76-200

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o., Słupsk

60-788

Poznan University of Meidcla Science, Poznan

022328

Institute of Oncology Bucharest, Bucharest

0081

Wilgers Oncology Centre, Pretoria

08916

H. Germans Trias i Pujol, ICO-Badalona, Badalona

08028

Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

08908

Catalan Institute of Oncology (ICO) Hospitalet, Barcelona

01230

Baskent University, Yüreğir

06010

Gulhane Research And Training Hospital, Ankara

06100

Ozel Liv Hospital, Ankara

Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam, Ankara

0906520

Memorial Ankara Hospital, Ankara

EX2 5DW

Royal Devon and Exeter Hospital NHS Trust, Exeter

EH4 2XU

Edinburgh Cancer Centre, Edinburgh

BS2 8ED

Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute, Bristol

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

CV2 2DX

University Hospital Coventry and Warwickshire Nhs Trust, Coventry

EC1A 7BE

Saint Bartholomew's Hospital, London

NW1 2PG

University College London Hospitals, London

M20 4BX

The Christie, Manchester

TA1 5DA

Taunton and Somerset NHS Foundation Trust, Taunton

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY