Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,535

Participants

Timeline

Start Date

July 14, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2031

Conditions
Melanoma
Interventions
DRUG

Fianlimab

Intravenous (IV) infusion

DRUG

Cemiplimab

IV infusion

DRUG

Pembrolizumab

IV infusion

DRUG

Placebo

IV infusion

Trial Locations (219)

41

RECRUITING

Clinica Internacional San Borja, San Borja

112

RECRUITING

LLC Todua Clinic, Tbilisi

1125

RECRUITING

Fundacion Cenit para la Investigacion en Neurociencias, Buenos Aires

2520

RECRUITING

Instituto Nacional de Enfermedades Neoplasicas, Lima

3100

RECRUITING

University Hospital St. Poelten, Sankt Pölten

4000

RECRUITING

Centro Medico San Roque, San Miguel de Tucumán

4032

RECRUITING

University of Debrecen, Debrecen

4103

RECRUITING

Universitaetsklinikum Leipzig, Leipzig

4215

SUSPENDED

Gold Coast University Hospital, Southport

6000

RECRUITING

LTD High Technology Hospital Medcenter, Batumi

6020

RECRUITING

Medical University Innsbruck, Innsbruck

7000

RECRUITING

Icon Cancer Centre Hobart, Hobart

7570

RECRUITING

Cape Town Oncology Trials, Kraaifontein

7632

RECRUITING

University of Pecs Medical School, Pécs

7925

RECRUITING

Groote Schuur Hospital, Cape Town

8036

RECRUITING

Medical University of Graz, Graz

10034

RECRUITING

Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinika, Prague

10060

RECRUITING

Istituto di Candiolo, FPO IRCCS, Candiolo

10117

RECRUITING

Charite - Universitaetsmedizin Berlin, Berlin

10126

RECRUITING

AOU Citta della Salute e della Scienza di Torino, Turin

12100

RECRUITING

Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo, Cuneo

12125

RECRUITING

Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO, Concepción

13011

RECRUITING

Clinica Peruano Americana, Trujillo

14004

RECRUITING

Hospital Universitario Reina Sofia, Córdoba

15009

RECRUITING

Hospital Teresa Herrera-Chuac (CHUAC), A Coruña

15036

SUSPENDED

Instituto Peruano de Oncologia and Radioterapia, Lima

16132

RECRUITING

Ospedale Policlinico San Martino - IRCCS, Genova

17007

RECRUITING

Catalan Institute Of Oncology - Girona, Girona

18014

RECRUITING

Hospital Universitario Virgen de las Nieves, Granada

19055

RECRUITING

Helios Klinik Schwerin, Schwerin

20014

RECRUITING

Onkologikoa, Donostia / San Sebastian

20052

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori, Monza

20089

RECRUITING

IRCCS Istituto Clinico Humanitas, Rozzano

20141

RECRUITING

Istituto Europeo di Oncologia, Milan

21200

RECRUITING

Dicle University Medical Faculty, Diyarbakır

21614

RECRUITING

Elbekliniken Buxtehude, Buxtehude

22000

RECRUITING

Trakya University, Edirne

22328

RECRUITING

Institute of Oncology Bucharest, Bucharest

23538

RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Luebeck, Lübeck

24105

RECRUITING

University of Kiel, Kiel

25030

RECRUITING

CHU Jean MINJOZ, Besançon

25123

RECRUITING

ASST Spedali Civili Brescia, Brescia

27003

RECRUITING

Hospital Universitario Lucus Augusti, Lugo

27584

RECRUITING

Gaziantep University Medical Faculty, Gaziantep

28007

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

28034

RECRUITING

Hospital Universitario Ramon y Cajal, Madrid

28040

RECRUITING

Hospital Fundacion Jimenez Diaz, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

28050

RECRUITING

Centro integral Oncologico HM Clara Campal, Madrid

28100

RECRUITING

SCDU di Oncologia AOU Maggiore Della Carita, Novara

29011

RECRUITING

Hospital Regional Universitario de Malaga, Málaga

30120

RECRUITING

Hospital Universitario Virgen de la Arrixaca, Murcia

31000

RECRUITING

Centro Estatal de Cancerologia de Chihuahua, Chihuahua City

32806

RECRUITING

Orlando Health, Inc, Orlando

33011

RECRUITING

Hospital Universitario Central de Asturias, Oviedo

33100

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale Udine, Udine

33176

RECRUITING

Miami Cancer Institute, Miami

34093

RECRUITING

Bezmialem University, Istanbul

34098

RECRUITING

Cerrahpasa Medical Hospital, Istanbul

34147

RECRUITING

Bakirkoy Sadi Konuk Training Hospital, Istanbul

34722

RECRUITING

Prof. Dr. Suleyman Yalcin Sehir Hospital, Istanbul

35100

RECRUITING

Ege University hospital, Izmir

35128

RECRUITING

IOV - Istituto Oncologico Veneto - IRCCS, Padua

35392

RECRUITING

University Hospital Giessen, Giessen

37075

RECRUITING

Universitatsmedizin Gottingen Klinik fur Dermatologie, Göttingen

37178

RECRUITING

Preparaciones Oncologicas SC, León

37920

RECRUITING

University of Tennessee Medical Center, Knoxville

38123

RECRUITING

Santa Chiara Regional Hospital, Trento

38700

RECRUITING

Centre Hospitalier Universitaire De Grenoble Alpes Service Dermatologie, Grenoble

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

41100

RECRUITING

Kocaeli Universitesi, Kocaeli

42055

RECRUITING

CHU Saint-Etienne - Hopital Nord, Saint-Etienne

44000

RECRUITING

Centre Hospitalier Universitaire de Nantes (CHU de Nantes) Hotel Dieu, Nantes

44106

TERMINATED

University Hospitals Seidmand Cancer Center, Cleveland

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

44280

RECRUITING

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

44791

RECRUITING

Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef Hospital, Bochum

45070

RECRUITING

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V., Zapopan

46009

RECRUITING

Instituto Valenciano de Oncologia, Valencia

46010

RECRUITING

INCLIVA-Instituto de Investigacion Sanitaria, Valencia

48157

RECRUITING

Fachklinik Hornheide, Münster

50005

RECRUITING

Fakultni Nemocnice Hradec Kralove, Hradec Králové

55131

RECRUITING

Universitatsmedizin der Johanned Gutenberg-Universitat Mainz, Mainz

56126

RECRUITING

U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo Oncologico, Pisa

59037

RECRUITING

Chru De Lille, Lille

60590

SUSPENDED

Universitatsklinik Frankfurt, Frankfurt

63003

RECRUITING

CHU Estaing, Service de Dermatologie, Clermont-Ferrand

64710

SUSPENDED

iCan Oncology Center, Monterrey

67000

RECRUITING

Clinique Sainte Anne/Strasbourg Oncologie Liberale, Strasbourg

68167

RECRUITING

University Medical Center Mannheim, Mannheim

69373

RECRUITING

Centre Leon Berard, Lyon

69495

RECRUITING

Hospices Civils de Lyon, Pierre-Bénite

70124

RECRUITING

Istituto dei Tumori, Bari

70852

RECRUITING

University Hospital Ostrava, Ostrava

71013

RECRUITING

Fondazione IRCSS Casa Sollievo Della Sofferenza, San Giovanni Rotondo

72037

RECRUITING

CH Le Mans - Plateforme de recherche clinique, Le Mans

72076

RECRUITING

Universitaetsapotheke Tuebingen, Tübingen

75005

RECRUITING

Hopital Cochin APHP, Paris

76031

RECRUITING

CHU Charles Nicolle Dermatologie, Rouen

80020

RECRUITING

Neurociencias Estudios Clinicos SC, Culiacán

80121

RECRUITING

Università della Campania Luigi Vanvitella, Napoli

80131

RECRUITING

IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale, Napoli

80337

RECRUITING

Klinikum der Universitat Munchen - LMU Klinik und Poliklinik fur Dermatologie und Allergologie Hautt, München

86021

RECRUITING

Hopital de la Miletrie Centre Hospitalier Universitaire de Poitiers, Poitiers

86179

RECRUITING

Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus Sud, Augsburg

90025

RECRUITING

The Angeles Clinic and Research Institute, Los Angeles

90419

RECRUITING

Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Nuremberg

91900

RECRUITING

FAICIC S. de R.L. de C.V., Veracruz

92093

RECRUITING

University of California San Diego, La Jolla

92100

RECRUITING

Hopital Ambroise Pare, Boulogne-Billancourt

93000

RECRUITING

Hopital Avicenne Service de Dermatologie du Pr Caux, Bobigny

93053

RECRUITING

University Clinic Regensburg, Regensburg

94010

RECRUITING

Hopitaux Universitaires Henri-Mondor, Créteil

94805

RECRUITING

Institut Gustave Roussy Cancer Center DITEP, Villejuif

97134

RECRUITING

Centro De Atencion E Investigacion Clinica En Oncologia Scp, Mérida

99089

RECRUITING

Helios Klinikum Erfurt Klinik fur Hautkrankheiten und Allergologie, Erfurt

200347

RECRUITING

Centrul de Oncologie Sf. Nectarie S.R.L, Craiova

290838

RECRUITING

Centro De Estudios Y Prevencion Del Cancer A. C., Tuxtla Gutiérrez

300210

RECRUITING

Oncocenter Oncologie Clinica S.R.L, Timișoara

300239

RECRUITING

Oncomed, Timișoara

400015

RECRUITING

Cardiomed SRL, Cluj-Napoca

400641

RECRUITING

Medisprof, Cluj-Napoca

407280

RECRUITING

SC Radiotherapy Center Cluj SRL, Cluj-Napoca

700106

RECRUITING

SC Centrul de Oncologie Euroclinic SRL, Iași

700383

RECRUITING

Regional Institute of Oncology, Iași

1240000

RECRUITING

Centro Oncologico Antofagasta Bradford Hill Norte, Antofagasta

2520598

RECRUITING

Oncocentro, Viña del Mar

7510032

RECRUITING

Oncovida, Santiago

7560907

RECRUITING

Universidad Mayor - Centro Oncologia de Precision, Santiago

8330456

RECRUITING

Hospital Clinico Universidad de Chile, Santiago

8420000

RECRUITING

Centro De Investigacion Clinica Bradford Hill, Recoleta

22793080

RECRUITING

Instituto COI, Rio de Janeiro

07962

RECRUITING

Atlantic Health System - Morristown Medical Center, Morristown

C1061

RECRUITING

DIABAID - Instituto de Asistencia Integral en Diabetes, Buenos Aires

C1125ABD

RECRUITING

Fundacion CENIT Centro Medico de Neurociencias, Buenos Aires

C1430EGF

RECRUITING

Clinica Adventista Belgrano, Caba

S2000KZE

RECRUITING

Instituto de Oncologia de Rosario, Rosario

05006

RECRUITING

Calvary North Adelaide Hospital, Adelaide

03220

RECRUITING

Barwon Health Andrew Love Cancer Centre, University Hospital Geelong, Geelong

03004

RECRUITING

The Alfred Hospital, Melbourne

04814

RECRUITING

The Townsville Hospital and Health Service, Townsville

03355

RECRUITING

Ballarat Oncology and Haematology Clinical Trials Unit, Wendouree

01090

RECRUITING

Medical University Of Vienna, Vienna

01200

RECRUITING

Cliniques Universitaires Saint-Luc, Brussels

08500

RECRUITING

AZ Groeninge, Campus Kennedylaan, Kortrijk

05000

RECRUITING

Clinique et Maternite Sainte-Elisabeth (CMSE), Namur

09100

RECRUITING

AZ Nikolaas, Sint-Niklaas

14784-400

RECRUITING

Fundacao Pio XII - Hospital de Amor de Barretos, Barretos

30130-090

RECRUITING

Centro Avancado de Tratamento Oncologico (CENANTRON), Belo Horizonte

81520-060

RECRUITING

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

98700-000

RECRUITING

Oncosite Centro De Pesquisa Clinica Em Oncologia, Ijuí

88301-220

RECRUITING

Clinica de Neoplasias Litoral/atarina Pesquisa Clínica, Itajaí

89201-260

RECRUITING

Instituto Joinvilense De Hematologia E Oncologia, Joinville

88501-001

RECRUITING

Animi Unidade de Tratamento Oncologico Ltda, Lages

95900-000

RECRUITING

Hospital Bruno Born, Lajeado

99010-080

RECRUITING

Hospital Sao Vicente de Paulo (HSVP) Instituto do Cancer, Passo Fundo

90035-001

RECRUITING

Hospital Moinhos de Vento, Porto Alegre

90035-903

RECRUITING

Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre

90610-000

RECRUITING

CPO - Centro de Pesquisas em Oncologia, Porto Alegre

76834-899

RECRUITING

Fundacao PIO XII - Hospital de Amor Amazonia, Porto Velho

41253- 190

RECRUITING

Hospital Sao Rafael, Salvador

20220-410

RECRUITING

INCA - Brazilian National Cancer Institute, Santo Cristo

15090-000

RECRUITING

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

01236-030

RECRUITING

Hemomed, São Paulo

01308-050

RECRUITING

Hospital Sirio Libanes (HSL), São Paulo

04014-002

RECRUITING

Sao Camilo Oncologia, São Paulo

M4N 3M5

RECRUITING

Sunnybrook Research Institute, Toronto

L4M 6M2

RECRUITING

Royal Victoria Regional Health Centre, Barrie

T6G-1Z2

RECRUITING

Cross Cancer Institute (CCI), Edmonton

E3B5N5

RECRUITING

Dr. Everett Chalmers Hospital, Fredericton

S7N 4H4

RECRUITING

Saskatoon Cancer Centre (SCC), Saskatoon

M5G 2M9

RECRUITING

University Health Network, Princess Margaret Cancer Centre, Toronto

033075

RECRUITING

HOPITAL SAINT ANDRE Chu De Bordeaux, Bordeaux

021000

RECRUITING

CHU de DIJON - Service de Dermatologie, Dijon

0112

RECRUITING

Israeli Georgian medical research clinic Helsicore, Tbilisi

0114

RECRUITING

LTD New Hospitals, Tbilisi

0144

RECRUITING

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

0159

RECRUITING

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

0160

RECRUITING

TIM -Tbilisi Institute of Medicine, Tbilisi

0168

RECRUITING

Medulla - Clinics And Medical Centers, Tbilisi

06847

RECRUITING

Staedtisches Klinikum Dessau, Dessau

01307

RECRUITING

Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet, Dresden

06484

RECRUITING

Harzklinikum, Klinik fur Dermatologie und Allergologie, Quedlinburg

04400

RECRUITING

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak, Nyíregyhaza

06720

RECRUITING

University of Szeged, Szeged

T12 E8YV

RECRUITING

Cork University Hospital, Cork

D04 T6F4

RECRUITING

St. Vincents University Hospital, Dublin

D08 NHY1

RECRUITING

St. James Hospital, Dublin

H91 YR71

RECRUITING

University College Hospital Galway, Galway

00144

RECRUITING

Istituti Fisioterapici Ospitalieri (IFO), Roma

00128

RECRUITING

Campus Bio-Medico di Roma, Rome

00167

RECRUITING

Istituto Dermopatico Dell'Immacolata Irccs, Rome

05100

RECRUITING

Azienda Ospedaliera S. Maria, Terni

1066 CX

RECRUITING

The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek Hospital, Amsterdam

9713 GZ

RECRUITING

University Medical Center Groningen, Groningen

04000

RECRUITING

Hospital Goyeneche, Arequipa

04001

RECRUITING

Centro Medico Monte Carmelo, Arequipa

07001

RECRUITING

Hospital Nacional Daniel Alcides Carrion, Bellavista

80-214

RECRUITING

Uniwersyteckie Centrum Kliniczne (UCK), Gdansk

31-115

RECRUITING

Narodowego Instytutu Onkologii im Maria Sklodowska Curie, Krakow

60-780

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

08-110

RECRUITING

Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii, Siedlce

76-200

RECRUITING

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka, Słupsk

02-781

RECRUITING

Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Warsaw

075100

RECRUITING

RTC Radiology Therapeutic Center SRL, Otopeni

02196

RECRUITING

The Medical Oncology Centre of Rosebank, Johannesburg

08916

RECRUITING

Hospital Universitari Germans Trias i Pujol (HUGTP), Badalona

08028

RECRUITING

Instituto Oncologico Dr Rosel, Barcelona

08041

SUSPENDED

Hospital de la Santa Creu i Sant Pau, Barcelona

08907

RECRUITING

Catalan Institute of Oncology (ICO) Hospitalet, Barcelona

01120

RECRUITING

Adana Baskent Hospital, Adana

06010

RECRUITING

Gulhane Training and Research Hospital, Ankara

06520

RECRUITING

Memorial Ankara Hospital, Ankara

06680

RECRUITING

Ozel Liv Hospital, Ankara

EX2 5DW

RECRUITING

Royal Devon and Exeter Hospital NHS Trust, Exeter

GU2 7XX

RECRUITING

Royal Surrey NHS Foundation Trust, Guildford

HU16 5JQ

RECRUITING

Hull University Teaching Hospitals NHS Trust, Hull

LS9 7TF

RECRUITING

Leeds Teaching Hospitals NHS Trust, Leeds

SE1 9RT

SUSPENDED

Guy's Hospital, London

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY