Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT05608291
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego, La Jolla, California, United States
University of California, San Francisco, San Francisco, California, United States
John Wayne Cancer Institute - Saint John's Health Center, Santa Monica, California, United States
The Melanoma And Skin Cancer Institute, Englewood, Colorado, United States
Miami Cancer Institute, Miami, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Northwestern Medical Group, Chicago, Illinois, United States
Massachusetts General Cancer Center, Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
NYU Langone Health, New York, New York, United States
Columbia University Medical Center, 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 University Medical Center, Durham, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
St. Luke's Hematology, Easton, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
SCRI Partners - Verdi Oncology, Nashville, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, United States
Intermountain Medical Center, Murray, Utah, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Virginia Cancer Specialist Research Institute, Fairfax, Virginia, United States
Fundacion CENIT para la investigacion en Neurociencias, Ciudad Autonoma, Buenos Aires, Argentina
DIABAID - Instituto de Asistencia Integral en Diabetes, Ciudad Autonoma, Buenos Aires, Argentina
Clinica Viedma S.A., Viedma, Rio Negro, Argentina
Instituto de Oncologia de Rosario - Departamento de Investigaciones, Rosario, Santa Fe, Argentina
Centro Medico San Roque, San Miguel de Tucumán, Tacuman Province, Argentina
Liverpool Hospital (Cancer Therapy Pharmacy), Liverpool, New South Wales, Australia
Calvary North Adelaid Hospital (HPS Pharmacies), Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Andrew Love Cancer Centre, University Hospital Geelong, Geelong, Victoria, Australia
Alfred Health, Melbourne, Victoria, Australia
One Clinical Research, Nedlands, Western Australia, Australia
VITAZ vzw - pharm Sara Van Opdenbosch t.a.v. apotheek, Sint Niklaas, East Flanders, Belgium
Cliniques Universitaires Saint-Luc, Brussels, Region De Bruxelles, Belgium
Campus Kennedylaan Apotheek, Kortrijk, West-Vlaaderen, Belgium
Centro Avancado de Tratamento Oncologico (CENANTRON), Belo Horizonte, Minas Geraise, Brazil
Hospital Erasto Gaertner, Curitiba, Parana, Brazil
Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA), Barra da Tijuca, Rio De Janeiro, Brazil
INCA - Brazilian National Cancer Institute, Santo Cristo, Rio De Janeiro, Brazil
ONCOSITE - CENTRO DE PESQUISA CLINICA EM ONCOLOGIA LTDA Setor Farmacia Pesquisa Clini, Ijui, Rio Grande Do Sul, Brazil
Hospital Sao Vicente de Paulo - Instituto do Cancer, Passo Fundo, Rio Grande Do Sul, Brazil
Associacao Hospitalar Moinhos de Vento, Centro de Pesquisa Clinica, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre - UPCO- pesquisa Clinica em Oncologia do HCPA, Porto Alegre, Rio Grande Do Sul, Brazil
CPO - Centro de Pesquisas em Oncologia, Porto Alegre, Rio Grande Do Sul, Brazil
Clinica de Neoplasias Litoral, Itajai, Santa Catarina, Brazil
Instituto Joinvilense de Hematologia e Oncologia, Joinville, Santa Catarina, Brazil
Animi Unidade de Tratamento Oncologico Ltda, Lages, Santa Catarina, Brazil
Instituto de Ensino e Pesquisas Sao Lucas - IEP HEMOMED, Sao Paulo, Sao Paulo Estado, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, Sao Paulo, Brazil
Hospital Sirio-Libanes, Sao Paulo, , Brazil
Nucleo de Pesquisa da Rede Sao Camilo (Instituto Brasileiro de Controle do Cancer), Sao Paulo, , Brazil
Dr. Everett Chalmers Hospital, Fredericton, New Brunswick, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Universidad Mayor - Centro Oncologia de Precision (PROFAR), Santiago, Metropolitana De Santiago, Chile
Clinica UC San Carlos de Apoquindo, Santiago, Metropolitana De Santiago, Chile
Oncovida, Santiago, Santiago Region Metropolitana De Santiago, Chile
Oncocentro APYS, Valparaiso, , Chile
University Hospital Hradec Kralove, Hradec Kralove, Bohemia, Czechia
University Hospital Ostrava Pharmacy, Ostrava, Moravia Region, Czechia
Masaryk Memorial Cancer Institute, Hospital Pharmacy, Brno, South Moravian, Czechia
CHU de DIJON - Pharmacie Essais Cliniques, Dijon, Bourgogne-Franche-Comte, France
Centre Georges Francois Leclerc, Dijon, Bourgogne-Franche-Comté, France
CHU Jean Minjoz, Besancon Cedex, Bourgogne, France
CHU Grenoble Alpes, La Tronche, Grenoble, France
Institut Claudius Regaud - Pharmacie, Toulouse, Haute-Garonne, France
Gustave Roussy - Pharmacie Essais Cliniques -1, Vaillant, Ile De France, France
Hopital Saint Louis - APHP, Service de Pharmacie - Niveau, Paris, Ile-de-France, France
CHU Lille, Pharmacie Centrale, Lille, Nord Deparment, France
Centre Francois Baclesse, Caen, Normandy, France
Hopital Saint Andre, Pharmacie, Bordeaux, Nouvelle-Aquitaine, France
Unite de Pharmacie Clinique Oncologique (UPCO), Montpellier, Occitanie Region, France
Hopital Ambroise Pare, Boulogne Billancourt, Paris, France
CHU HENRI MONDOR Pharmacie Secteur ESSAIS CLINIQUES, Creteil, Paris, France
CHU de NANTES Hotel Dieu, Nantes, Pays De La Loire Région, France
Sainte Catherine Institut du Cancer Avignon Provence, Avignon, Province Alpes Cote d'Azur, France
CHU G. Montpied, Pharmacie, secteur recherche clinique, Clermont-Ferrand, Puy-de-Dôme, France
CH Le Mans - CCS Pharmacie-essais cliniques, aile B, Le Mans, Sarthe, France
Hopital Avicenne Service Pharmacie Secteur essais cliniques, Bobigny, Seine Saint Denis, France
CHU Amiens-Picardie Site Sud, Amiens, Somme, France
Centre Hospitalier Universitaire de Nice,Hopital l Archet, Nice, , France
CHU Charles Nicolle, Rouen, , France
LTD Cancer Center of Adjara Autonomic Republic, Batumi, Adjara, Georgia
Israeli Georgian medical research clinic Helsicore, T'bilisi, South Caucasus, Georgia
LTD Research Institute of Clinical Medicine (LLC Todua Clinic), T'bilisi, South Caucasus, Georgia
LTD New Hospitals, T'bilisi, South Caucasus, Georgia
High Technology Medical Center, University Clinic Tbilisi, T'bilisi, South Caucasus, Georgia
Tbilisi Institute of Medicine (TIM), T'bilisi, South Caucasus, Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery, Tbilisi, South Caucasus, Georgia
University Medical Center Mannheim, Mannheim, Baden-Wurttemberg, Germany
University Hospital Tuebingen, Tubingen, Baden-Wurttemberg, Germany
Hautklinik Universitatsklinikum Erlangen, Erlangen, Bavaria, Germany
LMU Klinikum Munchen, Pharmacy, Munchen, Bavaria, Germany
Klinikum Darmstadt GmbH, Darmstadt, Hessen, Germany
Universitatsmedizin Gottingen, Gottingen, Lower Saxony, Germany
Helios Kliniken Schwerin GmbH, Apotheke, Schwerin, Mecklenburg Vorpommern, Germany
Universitaetstklinikum Muenster Central Study Coordination for innovative Dermatology (ZID), Muenster, North Rhine-Westphalia, Germany
Hohenzollernapotheke, Muenster, North Rhine-Westphalia, Germany
Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen, Rhindeland Palatinate, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH, Zentrale Krankenhausapotheke, Quedlinburg, Sachsen-Anhalt, Germany
Universitatsklinikum Carl Gustav Carus Dresden, Klinik Apotheke - building 60, Dresden, Saxony, Germany
UKSH-Campus Kiel, Kiel, Schleswig-Holstein, Germany
Campus Virchow Klinikum, Apotheke Zytostatika Studien, Charite - Universitatsmedizin Berlin,, Berlin, , Germany
Katholisches Klinikum Bochum -Zentral Apotheke, Bochum, , Germany
Klinikum Bremen-Ost - Studienambulanz Dermatologie, Bremen, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Universitaetsklinikum Essen, Apotheke, Essen, , Germany
Universitatsklinikum Regensburg Studienburo Dermatologie, Regensburg, , Germany
A Oncology Dpt, Laiko General Hospital of Athens, Goudi, Athens, Greece
A Oncology Dpt, Metropolitan Hospital, Athens, Pireas, Greece
Bioclinic of Thessaloniki, Thessaloniki, Pylaia, Greece
Iatriko Diavalkaniko Thessaloniki, Pharmacy, Thessaloniki, Pylaia, Greece
Theagenio Cancer Center, Efkarpia, Thessalonili, Greece
University Hospital Galway, Galway, Connacht, Ireland
Beaumont Hospital, Beaumont, Dublin, Ireland
University College Cork-Cork University Maternity Hospital, Cork, Munster, Ireland
St Vincent's University Hospital, Dublin, , Ireland
Haemek Medical Center, Afula, Northern District, Israel
The Chaim Sheba Medical Center, Ramat-Gan, Tel Aviv, Israel
Hadassah Ein Kerem Medical Center, Jerusalem, , Israel
UOC del Farmaco - PO San Salvatore, L'Aquila, Abruzzo, Italy
Universita della Campania Luigi Vanvitella, Napoli, Campania, Italy
Instituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Campania, Italy
Clinica Malattie Infettive, Azienda Ospedaliero Universitaria, Udine, Friuli-Venezia Giulia, Italy
Fondazione Policlinico Campus Bio-Medico, Rome, Lazio, Italy
Farmacia Ospedaliera, Fondazione Policlinico Universitario Agostini Gemeli IRCCS, Rome, Lazio, Italy
Farmacia Ospedaliera, Instituto Europeo di Oncologia, Milan, Lombardy, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari, Bari, Metropolitan City Of Bari, Italy
AO S.Croce E Carle, Cuneo, Piedmont, Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss), Roma, Rome Province, Italy
AO perugia SC Oncologia, Perugia, Umbria, Italy
Arcispedale SantAnna UOC Farmacia Ospedaliera Ufficio sperimentazioni cliniche, SETTORE 2B1 Presidi, Cona, Veneto, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita, Farmacia Ospedaliera, Novara, , Italy
UOC Oncologia Medica, Taormina, , Italy
Farmacia Ospedaliera - Azienda Ospedaliero Universitaria delle Marche, Torrette, , Italy
Ospedale S.Chiara - APSS di Trento - Magazzino Farmacia, Trento, , Italy
Preparaciones Oncologicas S. C., Leon Guanajuato, Guanajuato, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A de C.V, Zapopan, Jalisco, Mexico
iCan Oncology Center S.A de C.V., Monterrey, Nuevo Leon, Mexico
Neurociencias Estudios Clinicos S. C., Culiacan, Sinaloa, Mexico
FAICIC S. de R.L. de C.V., Veracruz, Veracruz Estado, Mexico
Centro de Atencion e Investigacion Clinica en Oncologia, Merida, Yucatan, Mexico
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii, Siedlce, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne (UCK), Gdansk, Pomeria, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka w Slupsku, Slupsk, Pomorskie, Poland
Centrul de Oncologie Sf. Nectarie S.R.L/SC, Craiova, Dolj, Romania
Radiotheraoy Center Cluj/Ph, Cluj, Floresti, Romania
Centrul De Oncologie Euroclinic, Iași, Moldava, Romania
Oncocenter-Oncologie Clinica SRL, Timisoara, Timis, Romania
Oncomed, Timisoara, Timis, Romania
Cardiomed, Cluj Napoca, Transylvania, Romania
Institul Oncologic Prof. Dr Ion Chiricuta, Cluj Napoca, Transylvania, Romania
Institute of Oncology Bucharest, Bucharest, , Romania
The Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
Wilgers Oncology Center, Pretoria, Gauteng, South Africa
Cape Gate Oncology Trials, Cape Town, Western Cape, South Africa
Hospital Universitario Virgen Macarena, Sevilla, Andalucia, Spain
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Hospital Universitario Marques De Valdecilla, Santander, Cantabria, Spain
Hospital Universitario Quiron Dexeus Barcelona, Barcelona, Catalonia, Spain
Area dassajos clinics/Medicaments en investigacio, Servei de Farmacia Hospital Clinic de Barcelona (ICMHO), Barcelona, Catalonia, Spain
Hospital Universitario Vall d'Hebron, Edificio General-Planta Baja, UITM, Unidad de Farmacia de Ensa, Barcelona, Catalonia, Spain
Hospital Universitario La Paz, Madrid, Madrid Provincia, Spain
Institut Catala d'Oncologia, Badalona, , Spain
Hospital Universitario Virgen de las Nieves, Granada, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital General Universitario Gregorio Maranon (HGUGM), Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Sbu Dr. A.Y. Ankara Onkoloji Suam, Ankara, Anatolia, Turkey
Gulhane Egitim ve Arastirma Hastanesi, Keçiören, Ankara, Turkey
Liv Hospital, Ankara, Central Anatolia, Turkey
Ankara Memorial Hospital, Ankara, Central Anatolia, Turkey
Adana Kisla Baskent Unv Hospital, Adana, Cilicia, Turkey
Dicle University, Faculty of Medicine, Diyarbakir, Diyarbakir Province, Turkey
Trakya Universitesi, Balkan Onkoloji Hastanesi Linik Arastirmar Odasi, Iskender, Edime, Turkey
Medical Park Gaziantep Hastanesi, Sehitkamil, Gaziantep, Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, Istanbul Province, Turkey
Istanbul Universitesi CerrahpaSa- Cerrahpasa Tip Fakultesi, Fatih, Istanbul, Turkey
Izmir Katip Celebi University Ataturk training and Research Hospital, Izmir, Izmir Province, Turkey
Kocaeli University Hospital, Umuttepe, Kocaeli, Turkey
Royal Devon University Healthcare NHS Foundation Trust, Clinical Trials Pharmacy, Exeter, Devon, United Kingdom
Clinical research pharmacy, Chelsea, London, United Kingdom
Pharmacy Clinical Trials, Pharmacy Department, Alexander Donald Building, Western General Hospital, Edinburgh, Lothian, United Kingdom
Clinical Trials Unit Bristol Haematology & Oncology Centre, Bristol, Somerset, United Kingdom
Musgrove Park Hospital, Somerset Foundation Trust, Taunton, Somerset, United Kingdom
Pharmacy Chemotherapy Unit, St Barthomews Hospital West Smithfield, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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