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ACTIVE NOT RECRUITING
NCT05352672
PHASE3

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. 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 drugs (which could make the drugs 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

Official title: A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1546

Start Date

2022-07-14

Completion Date

2031-09-16

Last Updated

2025-12-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Fianlimab

Intravenous (IV) infusion

DRUG

Cemiplimab

IV infusion

DRUG

Pembrolizumab

IV infusion

DRUG

Placebo

IV infusion

Locations (211)

UC San Diego

La Jolla, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Orlando Health

Orlando, Florida, United States

Seidman Cancer Center

Cleveland, Ohio, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

DIABAID - Instituto de Asistencia Integral en Diabetes

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Centro Medico Austral

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Centro de Investigacion Pergamino

Pergamino, Buenos Aires, Argentina

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)

Buenos Aires, Argentina

Exelsus

San Miguel de Tucumán, Argentina

Gold Coast Hospital and Health Service

Southport, Queensland, Australia

Townsville University Hospital

Townsville, Queensland, Australia

Calvary North Adelaide Hospital

North Adelaide, South Australia, Australia

Icon Cancer Centre Hobart

Hobart, Tasmania, Australia

Andrew Love Cancer Centre

Geelong, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

University Hospital Saint Poelten

Sankt Pölten, Lower Austria, Austria

Medical University of Graz

Graz, Styria, Austria

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Medical University Vienna

Vienna, Austria

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

AZ Nikolaas

Sint-Niklaas, West-Vlaanderen, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Centre Hospitalier Universitaire Universite Catholique de Louvain Namur Site Sainte Elisabeth

Namur, Belgium

Hospital Sao Rafael

Salvador, Estado de Bahia, Brazil

Hospital das Clinicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

Instituto do Cancer em Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Moinhos de vento

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisa em Oncologia PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Pio XII - Hospital de Amor Amazonia

Porto Velho, Rondônia, Brazil

Catarina Pesquisa Clinica

Itajaí, Santa Catarina, Brazil

Instituto Joinvilense de Hematologia e Oncologia

Joinville, Santa Catarina, Brazil

Animi Unidade de Tratamento Oncologico

Lages, Santa Catarina, Brazil

Fundacao Pio XII - Hospital de Amor

Barretos, São Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Oncosite Centro De Pesquisa Em Oncologia

Ijuí, Brazil

INCA - Brazilian National Cancer Institute

Rio de Janeiro, Brazil

Instituto COI

Rio de Janeiro, Brazil

Hemomed

São Paulo, Brazil

Hospital Sirio Libanes

São Paulo, Brazil

Sao Camilo Oncologia

São Paulo, Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

Dr. Everett Chalmers Hospital

Fredericton, New Brunswick, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hospital Clinico Universidad de Chile

Santiago, Independencia, Chile

Oncocentro APYS

Viña del Mar, Región de Valparaíso, Chile

Centro Oncologia de Precision Universidad Mayor

Santiago, Santiago Metropolitan, Chile

Oncovida

Santiago, Santiago Metropolitan, Chile

Centro Oncologico del Norte

Antofagasta, Chile

Bradford Hill

Santiago, Chile

University Hospital Hradec Kralove

Hradec Králové, North Central Czech Republic, Czechia

Fn Kralovske Vinohrady, Dermatological Clinic

Vinohrady, Prague, Czechia

University Hospital Ostrava

Ostrava, Czechia

Hospices Civils de Lyon

Pierre-Bénite, Auvergne-Rhône-Alpes, France

CHU-Dijon

Dijon, Burgundy, France

Besancon Regional University Hospital Center

Besançon, Doubs, France

Chu De Bordeaux

Bordeaux, Gironde, France

Centre Hospitalier Universitaire (CHU) de Lille

Lille, Hauts-de-France, France

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isere, France

CHU Charles Nicolle

Rouen, Normandy, France

Centre Hospitalier Universitaire De Poitiers

Poitiers, Nouvelle-Aquitaine, France

Centre Hospitalier Le Mans

Le Mans, Pays de la Loire Region, France

CHU de St Etienne

Saint Priest En Jarez, Pays de la Loire Region, France

Gustave Rroussy

Villejuif, Val de Marne / Ile de France, France

Hopital Ambroise Pare

Boulogne, France

CHU Estaing

Clermont-Ferrand, France

Centre Leon Berard

Lyon, France

Nantes University Hospital

Nantes, France

Clinique Sainte Anne

Strasbourg, France

Hopital Avicenne

Bobigny, Île-de-France Region, France

Hospital Henri Mondor

Créteil, Île-de-France Region, France

Cochin Hospital

Paris, Île-de-France Region, France

Cancer Center of Adjara

Batumi, Georgia

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

Tbilisi, Georgia

Israeli Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

LTD New Hospitals

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, Georgia

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia

TIM - Tbilisi Institute of Medicine

Tbilisi, Georgia

ltd Multiprofile Clinic Consilium Medulla

Tbilisi, Georgia

University Medical Center Mannheim

Mannheim, Baden-Wurttemberg, Germany

University of Tuebingen

Tübingen, Baden-Wurttemberg, Germany

LMU Klinikum

Munich, Bavaria, Germany

Klinikum Nurnberg, Hautklinik, Universitatsklinik fur Dermatologie der Paracelsus Medizinischen Privatuniversitat

Nuremberg, Bavaria, Germany

University Hospital of Regensburg

Regensburg, Bavaria, Germany

University Clinic Frankfurt

Frankfurt am Main, Hesse, Germany

University Hospital Giessen

Giessen, Hesse, Germany

Elbekliniken Stade Buxtehude

Buxtehude, Lower Saxony, Germany

Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Fachklinik Hornheide

Münster, North Rhine-Westphalia, Germany

Universitatsmedizin der Johannes-Gutenberg Universitat Mainz

Mainz, Rhineland-Palatinate, Germany

University Hospital Dresden

Dresden, Saxony, Germany

Universitatsklinikum Leipzig, AoR

Leipzig, Saxony, Germany

Dermatologie

Dessau, Saxony-Anhalt, Germany

Skin Cancer Center Harz

Quedlinburg, Saxony-Anhalt, Germany

University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel

Kiel, Schleswig-Holstein, Germany

Universitatsklinikum Schleswig Holstein Campus Luebeck

Lübeck, Schleswig-Holstein, Germany

Helios Klinikum Erfurt

Erfurt, Thuringia, Germany

Charite Universitaetsmedizin Berlin

Berlin, Germany

University Medical Center Gottingen

Göttingen, Germany

Helios Kliniken Schwerin

Schwerin, Germany

University of Pecs Medical School

Pécs, Baranya, Hungary

University of Debrecen

Debrecen, Hajdú-Bihar, Hungary

Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Galway University Hospital

Galway, Connacht, Ireland

Cork University Hospital

Cork, Ireland

Tallaght University Hospital

Dublin, Ireland

St Vincents University Hospital

Dublin, Ireland

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

Naples, Campania, Italy

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, Italy

Istituto Clinico Humanitas

Rozzano, Milan, Italy

FPO IRCCS Candiolo

Candiolo, Torino, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Istituto dei Tumori

Bari, Italy

Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

Brescia, Italy

Azienda Ospedaliera Santa Croce i Carle

Cuneo, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori.

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza

Monza, Italy

Istituto Nazionale Tumori IRCCS Fondazione G Pascale

Naples, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology

Novara, Italy

Vento Institute of Oncology IOV-IRCCS

Padova, Italy

Campus Bio-Medico di Roma

Rome, Italy

IRCCS Regina Elena National Cancer Institute

Rome, Italy

Istituto Dermopatico dell'Immacolata

Rome, Italy

Aou Citta della Salute e della Scienza di Torino - SC Dermatologia U

Torino, Italy

Santa Chiara Hospital

Trento, Italy

Azienda Sanitaria Universitaria del Friuli Centrale

Udine, Italy

Centro De Estudios Y Prevention Del Cancer

Tuxtla Gutiérrez, Chiapas, Mexico

Preparaciones Oncologica SC

León, Guanajuato, Mexico

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Investigacion Biomedica para el Desarrollo de Farmacos SA de CV

Zapopan, Jalisco, Mexico

iCan Oncology

Monterrey, Nuevo León, Mexico

Neurociencias Estudios Clinicos SC

Culiacán, Sinaloa, Mexico

Centro De Atencion E Investigacion Clinica En Oncologia SCP

Mérida, Yucatán, Mexico

Centro Estatal de Cancerologia

Chihuahua City, Mexico

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

Veracruz, Mexico

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

Veracruz, Mexico

Netherlands Cancer Institute

Amsterdam, Netherlands

University Medical Centre Groningen

Groningen, Netherlands

Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO

Concepción, Departamento de Junín, Peru

Clinica Peruano Americana (Private practice)

Trujillo, La Libertad, Peru

Clinica Oncosalud

San Borja, Lima region, Peru

Instituto Nacional de Enfermedades Neoplasicas

Surquillo, Lima region, Peru

Hospital Nacional Daniel A. Carrion

Lima, Provincia Constitucional del Callao, Peru

Hospital Goyeneche

Arequipa, Peru

Centro Medico Monte Carmelo

Arequipa, Peru

Clinica Internacional SA

Lima, Peru

Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

Siedlce, Mazxowieckie, Poland

Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, Pomeranian Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

Słupsk, Pomeranian, Poland

Poznan University of Meidcla Science

Poznan, Wielkopolska, Poland

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Institute of Oncology Bucharest

Bucharest, București, Romania

Cardiomed

Cluj-Napoca, Cluj, Romania

Medisprof

Cluj-Napoca, Cluj, Romania

Radiotherapy Center Cluj

Floreşti, Cluj, Romania

Sfantul Nectarie Oncology Center

Craiova, Dolj, Romania

SC RTC Radiology Therapeutic Center SRL

Otopeni, Ilfov, Romania

Oncocenter Oncologie Clinica S.R.L

Timișoara, Timiș County, Romania

Oncomed

Timișoara, Timiș County, Romania

Centrul De Oncologie Euroclinic

Iași, Romania

Regional Institute of Oncology

Iași, Romania

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

Cape Town Oncology Trials

Cape Town, Western Cape, South Africa

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

H. Germans Trias i Pujol, ICO-Badalona

Badalona, Barcelona, Spain

Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

Barcelona, Catalonia, Spain

Onkologikoa

Donostia / San Sebastian, Gipuzkoa, Spain

Hospital Clinico Universitario Virgen De La Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Teresa Herrera-Chuac

A Coruña, Spain/La Coruna, Spain

Catalan Institute of Oncology (ICO) Hospitalet

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Catalan Institute Of Oncology

Girona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario La Pa<

Madrid, Spain

Centro Integral Oncologico HM Clara Campal

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

Incliva - Instituto de Investigacion Sanitaria

Valencia, Spain

Baskent University

Yüreğir, Adana, Turkey (Türkiye)

Medical oncology

Istanbul, Bakirkoy, Turkey (Türkiye)

Ege University

Izmir, Bornova, Turkey (Türkiye)

Kocaeli University

İzmit, Kocaeli, Turkey (Türkiye)

Gaziantep Medicalpoint Hospital

Gaziantep, Sehitkamil, Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Ozel Liv Hospital

Ankara, Turkey (Türkiye)

Memorial Ankara Hospital

Ankara, Turkey (Türkiye)

Dicle University - Medical Faculty Campus

Diyarbakır, Turkey (Türkiye)

Trakya University

Edirne, Turkey (Türkiye)

Bezmialem University

Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

Istanbul, Turkey (Türkiye)

Royal Devon and Exeter Hospital NHS Trust

Exeter, Devon, United Kingdom

Hull University Teaching Hospitals NHS Trust

Cottingham, East Yorkshire, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Royal Surrey County Hospital

Guildford, United Kingdom