Spots Global Cancer Trial Database for Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
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Trial Identification
Brief Title: Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Official Title: A Phase 2 and Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Study ID: NCT05352672
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 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
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
The Angeles Clinic and Research Institute, Los Angeles, California, United States
Miami Cancer Institute, Miami, Florida, United States
Orlando Health, Inc, Orlando, Florida, United States
Atlantic Health System - Morristown Medical Center, Morristown, New Jersey, United States
University Hospitals Seidmand Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
DIABAID - Instituto de Asistencia Integral en Diabetes, Buenos Aires, , Argentina
Clinica Adventista Belgrano, Caba, , Argentina
Fundacion CENIT Centro Medico de Neurociencias, Ciudad Autonoma de Buenos Aires, , Argentina
Instituto de Oncologia de Rosario, Rosario, , Argentina
Centro Medico San Roque, San Miguel de Tucuman, , Argentina
Calvary North Adelaide Hospital, Adelaide, , Australia
Barwon Health Andrew Love Cancer Centre, University Hospital Geelong, Geelong, , Australia
Icon Cancer Centre Hobart, Hobart, , Australia
The Alfred Hospital, Melbourne, , Australia
Gold Coast University Hospital, Southport, , Australia
The Townsville Hospital and Health Service, Townsville, , Australia
Ballarat Oncology and Haematology Clinical Trials Unit, Wendouree, , Australia
Medical University Innsbruck, Innsbruck, Tyrol, Austria
Medical University of Graz, Graz, , Austria
University Hospital St. Poelten, St. Poelten, , Austria
Medical University Of Vienna, Vienna, , Austria
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
AZ Groeninge, Campus Kennedylaan, Kortrijk, , Belgium
Clinique et Maternite Sainte-Elisabeth (CMSE), Namur, , Belgium
AZ Nikolaas, Sint Niklaas, , Belgium
Fundacao Pio XII - Hospital de Amor de Barretos, Barretos, , Brazil
Centro Avancado de Tratamento Oncologico (CENANTRON), Belo Horizonte, , Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner, Curitiba, , Brazil
Oncosite Centro De Pesquisa Clinica Em Oncologia, Ijui, , Brazil
Clinica de Neoplasias Litoral/atarina Pesquisa Clínica, Itajai, , Brazil
Instituto Joinvilense De Hematologia E Oncologia, Joinville, , Brazil
Animi Unidade de Tratamento Oncologico Ltda, Lages, , Brazil
Hospital Bruno Born, Lajeado, , Brazil
Hospital Sao Vicente de Paulo (HSVP) Instituto do Cancer, Passo Fundo, , Brazil
Hospital Moinhos de Vento, Porto Alegre, , Brazil
Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre, , Brazil
CPO - Centro de Pesquisas em Oncologia, Porto Alegre, , Brazil
Fundacao PIO XII - Hospital de Amor Amazonia, Porto Velho, , Brazil
Instituto COI, Rio de Janeiro, , Brazil
Hospital Sao Rafael, Salvador, , Brazil
INCA - Brazilian National Cancer Institute, Santo Cristo, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Sao Jose do Rio Preto, , Brazil
Hemomed, Sao paulo, , Brazil
Hospital Sirio Libanes (HSL), Sao Paulo, , Brazil
Sao Camilo Oncologia, Sao Paulo, , Brazil
Sunnybrook Research Institute, Toronto, Ontario, Canada
Royal Victoria Regional Health Centre, Barrie, , Canada
Cross Cancer Institute (CCI), Edmonton, , Canada
Dr. Everett Chalmers Hospital, Fredericton, , Canada
Saskatoon Cancer Centre (SCC), Saskatoon, , Canada
University Health Network, Princess Margaret Cancer Centre, Toronto, , Canada
Centro De Investigacion Clinica Bradford Hill, Recoleta, Chi, Chile
Oncovida, Santiago, Region Metropolitana De Santiago, Chile
Centro Oncologico Antofagasta Bradford Hill Norte, Antofagasta, , Chile
Universidad Mayor - Centro Oncologia de Precision, Santiago, , Chile
Oncocentro, Vina del Mar, , Chile
Fakultni Nemocnice Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Ostrava, Ostrava, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinika, Prague 10, , Czechia
CHU Jean MINJOZ, Besancon Cedex, , France
Hopital Avicenne Service de Dermatologie du Pr Caux, Bobigny, , France
HOPITAL SAINT ANDRE Chu De Bordeaux, Bordeaux Cedex, , France
Hopital Ambroise Pare, Boulogne Billancourt, , France
CHU Estaing, Service de Dermatologie, Clermont-Ferrand, , France
Hopitaux Universitaires Henri-Mondor, Creteil, , France
CHU de DIJON - Service de Dermatologie, Dijon, , France
Centre Hospitalier Universitaire De Grenoble Alpes Service Dermatologie, Grenoble, , France
CH Le Mans - Plateforme de recherche clinique, Le Mans, , France
Chru De Lille, Lille Cedex, , France
Centre Leon Berard, Lyon cedex 08, , France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) Hotel Dieu, Nantes, , France
Hopital Cochin APHP, Paris, , France
Hospices Civils de Lyon, Pierre Benite Cedex, , France
Hopital de la Miletrie Centre Hospitalier Universitaire de Poitiers, Poitiers Cedex, , France
CHU Charles Nicolle Dermatologie, Rouen, , France
CHU Saint-Etienne - Hopital Nord, Saint-Etienne, , France
Clinique Sainte Anne/Strasbourg Oncologie Liberale, Strasbourg, , France
Institut Gustave Roussy Cancer Center DITEP, Villejuif Cedex, , France
LTD High Technology Hospital Medcenter, Batumi, , Georgia
Israeli Georgian medical research clinic Helsicore, Tbilisi, , Georgia
LTD New Hospitals, Tbilisi, , Georgia
LTD 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
Medulla - Clinics And Medical Centers, Tbilisi, , Georgia
LLC Todua Clinic, Tbilisi, , Georgia
Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus Sud, Augsburg, , Germany
Charite - Universitaetsmedizin Berlin, Berlin, , Germany
Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef Hospital, Bochum, , Germany
Elbekliniken Buxtehude, Buxtehude, , Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet, Dresden, , Germany
Helios Klinikum Erfurt Klinik fur Hautkrankheiten und Allergologie, Erfurt, , Germany
Universitatsklinik Frankfurt, Frankfurt, , Germany
University Hospital Giessen, Giessen, , Germany
Universitatsmedizin Gottingen Klinik fur Dermatologie, Göttingen, , Germany
University of Kiel, Kiel, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck, Luebeck, , Germany
University Medical Center Mannheim, Mannheim, , Germany
Fachklinik Hornheide, Muenster, , Germany
Harzklinikum, Klinik fur Dermatologie und Allergologie, Quedlinburg, , Germany
University Clinic Regensburg, Regensburg, , Germany
Helios Klinik Schwerin, Schwerin, , Germany
University of Debrecen, Debrecen, , Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak, Nyíregyhaza, , Hungary
University of Pecs Medical School, Pecs, , Hungary
University of Szeged, Szeged, , Hungary
Cork University Hospital, Cork, , Ireland
St. Vincents University Hospital, Dublin 4, , Ireland
St. James Hospital, Dublin, , Ireland
University College Hospital Galway, Galway, , Ireland
Istituto dei Tumori, Bari, , Italy
ASST Spedali Civili Brescia, Brescia, , Italy
Istituto di Candiolo, FPO IRCCS, Candiolo, , Italy
Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo, Cuneo, , Italy
Ospedale Policlinico San Martino - IRCCS, Genova, , Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, , Italy
Università della Campania Luigi Vanvitella, Napoli, , Italy
IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale, Napoli, , Italy
SCDU di Oncologia AOU Maggiore Della Carita, Novara, , Italy
IOV - Istituto Oncologico Veneto - IRCCS, Padova, , Italy
U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo Oncologico, Pisa, , Italy
Campus Bio-Medico di Roma, Rome, , Italy
Istituto Dermopatico Dell'Immacolata Irccs, Rome, , Italy
Fondazione IRCSS Casa Sollievo Della Sofferenza, San Giovanni Rotondo, , Italy
Azienda Ospedaliera S. Maria, Terni, , Italy
Santa Chiara Regional Hospital, Trento, , Italy
AOU Citta della Salute e della Scienza di Torino, Turin, , Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale Udine, Udine, , Italy
Centro Estatal de Cancerologia de Chihuahua, Chihuahua, , Mexico
Neurociencias Estudios Clinicos SC, Culiacan, , Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, , Mexico
Preparaciones Oncologicas SC, Leon, , Mexico
Centro De Atencion E Investigacion Clinica En Oncologia Scp, Merida, , Mexico
iCan Oncology Center, Monterrey, , Mexico
Centro De Estudios Y Prevencion Del Cancer A. C., Tuxtla Gutierrez, , Mexico
FAICIC S. de R.L. de C.V., Veracruz, , Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V., Zapopan, , Mexico
The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Centro Medico Monte Carmelo, Arequipa, , Peru
Hospital Nacional Daniel Alcides Carrion, Bellavista, , Peru
Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO, Concepcion, , Peru
Instituto Peruano de Oncologia and Radioterapia, Lima, , Peru
Clinica Peruano Americana, Trujillo, , Peru
Uniwersyteckie Centrum Kliniczne (UCK), Gdansk, , Poland
Narodowego Instytutu Onkologii im Maria Sklodowska Curie, Krakow, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, , Poland
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii, Siedlce, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka, Slupsk, , Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Warszawa, , Poland
Institute of Oncology Bucharest, Bucharest, , Romania
Medisprof, Cluj Napoca, , Romania
Cardiomed SRL, Cluj-Napoca, , Romania
SC Radiotherapy Center Cluj SRL, Cluj, , Romania
Centrul de Oncologie Sf. Nectarie S.R.L, Craiova, , Romania
SC Centrul de Oncologie Euroclinic SRL, Iasi, , Romania
Regional Institute of Oncology, Iasi, , Romania
RTC Radiology Therapeutic Center SRL, Otopeni, , Romania
Oncocenter Oncologie Clinica S.R.L, Timisoara, , Romania
Oncomed, Timisoara, , Romania
Groote Schuur Hospital, Cape Town, , South Africa
The Medical Oncology Centre of Rosebank, Johannesburg, , South Africa
Cape Town Oncology Trials, Kraaifontein, , South Africa
Hospital Teresa Herrera-Chuac (CHUAC), A Coruna, , Spain
Hospital Universitari Germans Trias i Pujol (HUGTP), Badalona, , Spain
Instituto Oncologico Dr Rosel, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Catalan Institute of Oncology (ICO) Hospitalet, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Catalan Institute Of Oncology - Girona, 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 Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Centro integral Oncologico HM Clara Campal, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Universitario Virgen de la Arrixaca, Múrcia, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Onkologikoa, San Sebastian, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
INCLIVA-Instituto de Investigacion Sanitaria, Valencia, , Spain
Adana Baskent Hospital, Adana, , Turkey
Gulhane Training and Research Hospital, Ankara, , Turkey
Memorial Ankara Hospital, Ankara, , Turkey
Ozel Liv Hospital, Ankara, , Turkey
Dicle University Medical Faculty, Diyarbakir, , Turkey
Trakya University, Edirne, , Turkey
Gaziantep University Medical Faculty, Gaziantep, , Turkey
Bezmialem University, Istanbul, , Turkey
Cerrahpasa Medical Hospital, Istanbul, , Turkey
Bakirkoy Sadi Konuk Training Hospital, Istanbul, , Turkey
Prof. Dr. Suleyman Yalcin Sehir Hospital, Istanbul, , Turkey
Kocaeli Universitesi, Kocaeli, , Turkey
Royal Devon and Exeter Hospital NHS Trust, Exeter, Devon, United Kingdom
Royal Surrey NHS Foundation Trust, Guildford, , United Kingdom
Hull University Teaching Hospitals NHS Trust, Hull, , United Kingdom
Leeds Teaching Hospitals NHS Trust, Leeds, , United Kingdom
Guy's Hospital, London, , United Kingdom
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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