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ACTIVE NOT RECRUITING
NCT05608291
PHASE3

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

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 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.

Official title: A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1564

Start Date

2023-01-16

Completion Date

2030-02-15

Last Updated

2025-05-13

Healthy Volunteers

No

Conditions

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

Locations (211)

UC San Diego

La Jolla, California, United States

UCSF Medical Center at Mission Bay

San Francisco, California, United States

John Wayne Cancer Institute (JWCI)

Santa Monica, California, United States

The Melanoma And Skin Cancer Institute

Englewood, Colorado, United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Columbia University

New York, New York, United States

University of Rochester

Rochester, New York, United States

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Duke Cancer Institute, University Hospital

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University James Comprehensive Cancer Center

Columbus, Ohio, United States

St Lukes University Health Network

Easton, Pennsylvania, United States

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Tennessee Oncology - Centennial Clinic Location

Nashville, Tennessee, United States

Verdi Oncology

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Fundacion Centro de Investigaciones para la Transformacion (CENIT)

Caba, Buenos Aires, Argentina

Centro de Investigacion Pergamino

Pergamino, Buenos Aires, Argentina

Clinica Viedma S.A.

Viedma, Río Negro Province, Argentina

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

DIABAID - Instituto de Asistencia Integral en Diabetes

Caba, Argentina

Blacktown Cancer and Haematology Centre - Blacktown Hospital

Blacktown, New South Wales, Australia

Lismore Base Hospital

Lismore, New South Wales, Australia

Liverpool Hospital - Cancer Therapy Centre

Liverpool, New South Wales, Australia

Melanoma Institute of Australia

Wollstonecraft, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Calvary North Adelaide Hospital

North Adelaide, South Australia, Australia

Eastern Health

Box Hill, Victoria, Australia

Andrew Love Cancer Centre

Geelong, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

One Clinical Research at Hollywood Private Hospital

Nedlands, Western Australia, Australia

Vitaz campus Sint-Niklaas Moerland

Sint-Niklaas, Oost-Vlaanderen, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

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

INCA Instituto Nacional de Cancer

Santo Cristo, Rio de Janeiro, Brazil

Oncosite Centro De Pesquisa Em Oncologia

Ijuí, 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

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 - Hospital de Base

São José do Rio Preto, São Paulo, Brazil

Unimed Sorocaba

Sorocaba, São Paulo, Brazil

Instituto COI

Rio de Janeiro, Brazil

Hemomed

São Paulo, Brazil

Hospital Sirio Libanes

São Paulo, Brazil

Sao Camilo Oncologia

São Paulo, Brazil

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

Oncocentro APYS

Viña del Mar, Región de Valparaíso, Chile

Clinica UC San Carlos de Apoquindo

Santiago, Santiago Metropolitan, Chile

Centro Oncologia de Precision Universidad Mayor

Santiago, Santiago Metropolitan, Chile

Masaryk Memorial Cancer Institute

Brno, Brno Mesto, Czechia

University Hospital Hradec Kralove

Hradec Králové, North Central Czech Republic, Czechia

University Hospital Ostrava

Ostrava, Czechia

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, France

CHU-Dijon

Dijon, Burgundy, France

Besancon Regional University Hospital Center

Besançon, Doubs, France

Chu De Bordeaux

Bordeaux, Gironde, France

Institut Claudius Regaud, IUCT-Oncopole

Toulouse, Haute-Garonne, France

CHU de Lille

Lille, Hauts-de-France, France

Service de Dermatologie CHU Saint Eloi

Montpellier, Herault, France

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, Isere, France

Centre Francois Baclesse (CFB)

Caen, Normandy, France

Centre Hospitalier Le Mans

Le Mans, Pays de la Loire Region, France

Nantes University Hospital

Nantes, Pays de la Loire Region, France

CHU Amiens-Picardie

Amiens, Picardie, France

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, France

N_Hôpital Ambroise-Paré

Boulogne-Billancourt, France

CHU Estaing

Clermont-Ferrand, France

Centre Hospitalier Universitaire De Nice Hopital De L Archet

Nice, France

Centre Hospitalier de Valence

Valence, France

Institut Gustave Roussy

Villejuif, France

Hopital Avicenne

Bobigny, Île-de-France Region, France

Hospital Henri Mondor

Créteil, Île-de-France Region, France

Saint Louis Hospital

Paris, Île-de-France Region, France

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, Caucasus, Georgia

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

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia

TIM - Tbilisi Institute of Medicine

Tbilisi, Georgia

University Medical Center Mannheim

Mannheim, Baden-Wurttemberg, Germany

University of Tuebingen

Tübingen, Baden-Wurttemberg, Germany

University Hospital Augsburg

Augsburg, Bavaria, Germany

Dermatology Erlangen

Erlangen, Bavaria, Germany

LMU Klinikum

Munich, Bavaria, Germany

University Hospital of Regensburg

Regensburg, Bavaria, Germany

Klinikum Darmstadt GmbH

Darmstadt, Hesse, Germany

University Clinic Frankfurt

Frankfurt am Main, Hesse, Germany

University Medical Center Goettingen

Göttingen, Lower Saxony, Germany

Helios Kliniken Schwerin

Schwerin, Mecklenburg-Vorpommern, Germany

Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Universitatsklinikum Essen

Essen, North Rhine-Westphalia, Germany

University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Fachklinik Hornheide

Münster, North Rhine-Westphalia, Germany

Hautklinik

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

University Hospital Dresden

Dresden, Saxony, 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

Klinikum Bremen Ost

Bremen, Germany

National and Kapodistrian University of Athens

Athens, Attica, Greece

Metropolitan Hospital

Neo Faliro, Attica, Greece

Ongology Theageneio Thessaloniki

Thessaloniki, Greece

BioClinic Thessaloniki

Thessaloniki, Greece

Interbalkan Medical Center

Thessaloniki, Greece

Galway University Hospital

Galway, Connacht, Ireland

Cork University Hospital

Cork, Ireland

Beaumont Hospital

Dublin, Ireland

St Vincents University Hospital

Dublin, Ireland

Haemek Medical Center

Afula, Northern District, Israel

Hadassah Medical Organization

Jerusalem, Israel

Sheba Medical Center

Tel Litwinsky, Israel

Clinica Oncologica, AOU Riuniti Ancona

Ancona, An, Italy

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

Naples, Campania, Italy

Istituto Romagnolo per lo Studio dei Tumori (IRST)

Meldola, Forli Cesena, Italy

Istituto Clinico Humanitas

Milan, Lombardy, Italy

Istituto dei Tumori

Bari, Italy

Azienda Ospedaliera Santa Croce i Carle

Cuneo, Italy

Istituto Europeo di Oncologia

Milan, Italy

Instituto Nazionale Tumori Fondazione Giovanni Pascale

Naples, Italy

University of Perugia

Perugia, Italy

Fondazione Policlinico Universitrio a. Gemelli - IRCCS

Rome, Italy

Campus Bio-Medico di Roma

Rome, Italy

Istituto Dermopatico dell'Immacolata

Rome, Italy

Santa Chiara Hospital

Trento, Italy

Azienda Sanitaria Universitaria del Friuli Centrale

Udine, Italy

Preparaciones Oncologica SC

León, Guanajuato, Mexico

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Pan American Clinical Research

Guadalajara, 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

Faicic Centro de Investigacion Clinica de Veracruz

Veracruz, Mexico

Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

Siedlce, Mazxowieckie, Poland

UCK

Gdansk, Pomeranian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

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

Słupsk, Pomeranian Voivodeship, Poland

Poznan University of Meidcla Science

Poznan, Wielkopolska, Poland

Institute of Oncology Bucharest

Bucharest, București, Romania

Cardiomed

Cluj-Napoca, Cluj, Romania

Institute of Oncology Prof. Dr Ion Chirircuta

Cluj-Napoca, Cluj, Romania

Radiotherapy Center Cluj

Floreşti, Cluj, Romania

Sfantul Nectarie Oncology Center

Craiova, Dolj, Romania

Oncocenter Oncologie Clinica S.R.L

Timișoara, Timiș County, Romania

Oncomed

Timișoara, Timiș County, Romania

Centrul De Oncologie Euroclinic

Iași, Romania

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

Wilgers Oncology Centre

Pretoria, Gauteng, South Africa

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

Cape Town Oncology Trials

Kraaifontein, Western Cape, South Africa

H. Germans Trias i Pujol, ICO-Badalona

Badalona, Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

Barcelona, Catalonia, Spain

Hospital Universitario Central De Asturias

Oviedo, Principality of Asturias, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Catalan Institute of Oncology (ICO) Hospitalet

Barcelona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM

Madrid, Spain

Hospital Universitario La Pa<

Madrid, Spain

Centro Integral Oncologico HM Clara Campal

Madrid, 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)

Dicle University - Medical Faculty Campus

Sur, Diyarbakır, Turkey (Türkiye)

Kocaeli University

İzmit, Kocaeli, Turkey (Türkiye)

Gaziantep Medicalpoint Hospital

Gaziantep, Sehitkamil, Turkey (Türkiye)

Gulhane Research And Training Hospital

Ankara, Turkey (Türkiye)

Ozel Liv Hospital

Ankara, Turkey (Türkiye)

Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

Ankara, Turkey (Türkiye)

Memorial Ankara Hospital

Ankara, Turkey (Türkiye)

Trakya University

Edirne, 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

Edinburgh Cancer Centre

Edinburgh, Lothian, United Kingdom

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

Bristol, Somerset, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

University Hospital Coventry and Warwickshire Nhs Trust

Coventry, West Midlands, United Kingdom

Saint Bartholomew's Hospital

London, United Kingdom

University College London Hospitals

London, United Kingdom

The Christie

Manchester, United Kingdom

Taunton and Somerset NHS Foundation Trust

Taunton, United Kingdom