New immunotherapy duo aims to stop melanoma recurrence
NCT ID NCT05608291
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether combining two immunotherapy drugs—fianlimab and cemiplimab—can better prevent melanoma from coming back after surgical removal, compared to the standard drug pembrolizumab. The study enrolls people with high-risk melanoma (stages IIB–IV) who have had all visible cancer removed. Participants receive either the combination or pembrolizumab every three weeks, and researchers track how long they remain cancer-free.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- fianlimab and cemiplimab (combination immunotherapy)
- What this could lead to
- If successful, this combination could offer a new option to reduce the risk of melanoma returning after surgery, potentially improving relapse-free survival.
- What could go wrong
- This is an early-stage comparison against an already approved drug, so the new combination may not prove superior. Side effects from immunotherapy can be serious, including immune-related inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
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Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
Tbilisi, 0112, Georgia
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Alfred Hospital
Melbourne, Victoria, 3004, Australia
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Andrew Love Cancer Centre
Geelong, Victoria, 3220, Australia
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Animi Unidade de Tratamento Oncologico
Lages, Santa Catarina, 88501-001, Brazil
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Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
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Azienda Ospedaliera Santa Croce i Carle
Cuneo, 12100, Italy
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Azienda Sanitaria Universitaria del Friuli Centrale
Udine, 33100, Italy
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Baskent University
Yüreğir, Adana, 01230, Turkey (Türkiye)
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Beaumont Hospital
Dublin, D09 V2N0, Ireland
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Besancon Regional University Hospital Center
Besançon, Doubs, 25000, France
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BioClinic Thessaloniki
Thessaloniki, 54622, Greece
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Blacktown Cancer and Haematology Centre - Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
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Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
Bristol, Somerset, BS2 8ED, United Kingdom
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CHU Amiens-Picardie
Amiens, Picardie, 80000, France
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CHU Estaing
Clermont-Ferrand, 63003, France
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CHU de Lille
Lille, Hauts-de-France, 59000, France
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CHU-Dijon
Dijon, Burgundy, 21000, France
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Calvary North Adelaide Hospital
North Adelaide, South Australia, 5006, Australia
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Campus Bio-Medico di Roma
Rome, 00128, Italy
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Cancer Center of Adjara
Batumi, 6000, Georgia
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Cape Town Oncology Trials
Kraaifontein, Western Cape, 7570, South Africa
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Cardiomed
Cluj-Napoca, Cluj, 400015, Romania
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Catalan Institute of Oncology (ICO) Hospitalet
Barcelona, 08908, Spain
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Catarina Pesquisa Clinica
Itajaí, Santa Catarina, 88301-220, Brazil
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Centre Francois Baclesse (CFB)
Caen, Normandy, 14076, France
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Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, 21000, France
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Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, 72037, France
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Centre Hospitalier Universitaire De Nice Hopital De L Archet
Nice, 06202, France
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Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isere, 38700, France
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Centre Hospitalier de Valence
Valence, 26000, France
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Centro De Atencion E Investigacion Clinica En Oncologia SCP
Mérida, Yucatán, 97134, Mexico
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Centro Integral Oncologico HM Clara Campal
Madrid, 28050, Spain
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Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, 7560907, Chile
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Centro de Investigacion Pergamino
Pergamino, Buenos Aires, B2700CPM, Argentina
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Centro de Pesquisa em Oncologia PUCRS
Porto Alegre, Rio Grande do Sul, 90619900, Brazil
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Centrul De Oncologie Euroclinic
Iași, 700106, Romania
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Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
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Chu De Bordeaux
Bordeaux, Gironde, 33075, France
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Clinica Oncologica, AOU Riuniti Ancona
Ancona, An, 60020, Italy
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Clinica UC San Carlos de Apoquindo
Santiago, Santiago Metropolitan, 7550000, Chile
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Clinica Viedma S.A.
Viedma, Río Negro Province, 8500, Argentina
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Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
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Columbia University
New York, New York, 10032, United States
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Copernicus Podmiot Leczniczy Sp. z o.o.Wojewodzie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, 80-219, Poland
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Cork University Hospital
Cork, T12 EC8P, Ireland
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DIABAID - Instituto de Asistencia Integral en Diabetes
Caba, 1061, Argentina
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Dermatology Erlangen
Erlangen, Bavaria, 91054, Germany
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Dicle University - Medical Faculty Campus
Sur, Diyarbakır, 21200, Turkey (Türkiye)
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Dr. Everett Chalmers Hospital
Fredericton, New Brunswick, E3B 5N5, Canada
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Duke Cancer Institute, University Hospital
Durham, North Carolina, 27710, United States
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Eastern Health
Box Hill, Victoria, 3128, Australia
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Edinburgh Cancer Centre
Edinburgh, Lothian, EH4 2XU, United Kingdom
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Fachklinik Hornheide
Münster, North Rhine-Westphalia, 48157, Germany
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Faicic Centro de Investigacion Clinica de Veracruz
Veracruz, 91910, Mexico
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Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
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Fondazione Policlinico Universitrio a. Gemelli - IRCCS
Rome, 000168, Italy
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Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
São José do Rio Preto, São Paulo, 15090-000, Brazil
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Fundacao Pio XII - Hospital de Amor
Barretos, São Paulo, 14784400, Brazil
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Fundacion Centro de Investigaciones para la Transformacion (CENIT)
Caba, Buenos Aires, 1125, Argentina
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Galway University Hospital
Galway, Connacht, H91 YR71, Ireland
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Gaziantep Medicalpoint Hospital
Gaziantep, Sehitkamil, 27584, Turkey (Türkiye)
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Groote Schuur Hospital
Cape Town, Western Cape, 7925, South Africa
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Gulhane Research And Training Hospital
Ankara, 06010, Turkey (Türkiye)
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H. Germans Trias i Pujol, ICO-Badalona
Badalona, Barcelona, 08916, Spain
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Hadassah Medical Organization
Jerusalem, 91120, Israel
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Haemek Medical Center
Afula, Northern District, 18340000, Israel
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Hautklinik
Ludwigshafen am Rhein, Rhineland-Palatinate, D-67063, Germany
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Helios Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
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Helios Klinikum Erfurt
Erfurt, Thuringia, D-99089, Germany
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Hemomed
São Paulo, 01236030, Brazil
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Hopital Avicenne
Bobigny, Île-de-France Region, 93000, France
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Hospital Clinic de Barcelona
Barcelona, 08036, Spain
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Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
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Hospital Henri Mondor
Créteil, Île-de-France Region, 94000, France
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Hospital Moinhos de vento
Porto Alegre, Rio Grande do Sul, 90440140, Brazil
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Hospital Sirio Libanes
São Paulo, 01308-050, Brazil
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Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid, 28041, Spain
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Hospital Universitario Central De Asturias
Oviedo, Principality of Asturias, 33011, Spain
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Hospital Universitario La Pa<
Madrid, 28046, Spain
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Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
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Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
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Hospital Universitario Virgen Macarena
Seville, 41009, Spain
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Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
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Hospital Vall d'Hebron
Barcelona, 08035, Spain
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Hospital das Clinicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-090, Brazil
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Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035007, Brazil
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INCA Instituto Nacional de Cancer
Santo Cristo, Rio de Janeiro, 20220-410, Brazil
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Incliva - Instituto de Investigacion Sanitaria
Valencia, 46010, Spain
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Institut Claudius Regaud, IUCT-Oncopole
Toulouse, Haute-Garonne, 31059, France
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Institut Gustave Roussy
Villejuif, 94805, France
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Institute of Oncology Bucharest
Bucharest, Bucharest, 022328, Romania
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Institute of Oncology Prof. Dr Ion Chirircuta
Cluj-Napoca, Cluj, 400015, Romania
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Instituto COI
Rio de Janeiro, 23793-080, Brazil
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Instituto Joinvilense de Hematologia e Oncologia
Joinville, Santa Catarina, 89201260, Brazil
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Instituto Nazionale Tumori Fondazione Giovanni Pascale
Naples, 80131, Italy
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Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
Barcelona, Catalonia, 08028, Spain
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Instituto Valenciano de Oncologia
Valencia, 46009, Spain
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Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, S2000KZE, Argentina
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Instituto do Cancer em Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-090, Brazil
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Interbalkan Medical Center
Thessaloniki, 57001, Greece
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Intermountain Medical Center
Murray, Utah, 84107, United States
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Israeli Georgian Medical Research Clinic Helsicore
Tbilisi, 0112, Georgia
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Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
Istanbul, 81450, Turkey (Türkiye)
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Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
Istanbul, 34450, Turkey (Türkiye)
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Istituto Clinico Humanitas
Milan, Lombardy, 20089, Italy
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Istituto Dermopatico dell'Immacolata
Rome, 00167, Italy
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Istituto Europeo di Oncologia
Milan, 20141, Italy
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Istituto Romagnolo per lo Studio dei Tumori (IRST)
Meldola, Forli Cesena, 47014, Italy
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Istituto dei Tumori
Bari, 70124, Italy
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JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 0159, Georgia
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John Wayne Cancer Institute (JWCI)
Santa Monica, California, 90404, United States
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Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Klinikum Bremen Ost
Bremen, 28325, Germany
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Klinikum Darmstadt GmbH
Darmstadt, Hesse, 64283, Germany
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Kocaeli University
İzmit, Kocaeli, 41380, Turkey (Türkiye)
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LMU Klinikum
Munich, Bavaria, 80337, Germany
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LTD New Hospitals
Tbilisi, 0114, Georgia
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Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
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Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
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Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
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Lismore Base Hospital
Lismore, New South Wales, 2480, Australia
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Liverpool Hospital - Cancer Therapy Centre
Liverpool, New South Wales, 2170, Australia
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Masaryk Memorial Cancer Institute
Brno, Brno Mesto, 65653, Czechia
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Siedlce, Mazxowieckie, 08-110, Poland
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Melanoma Institute of Australia
Wollstonecraft, New South Wales, 2065, Australia
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Memorial Ankara Hospital
Ankara, 0906520, Turkey (Türkiye)
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Metropolitan Hospital
Neo Faliro, Attica, 18547, Greece
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Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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N_Hôpital Ambroise-Paré
Boulogne-Billancourt, 92100, France
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Nantes University Hospital
Nantes, Pays de la Loire Region, 44093, France
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National and Kapodistrian University of Athens
Athens, Attica, 11527, Greece
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Neurociencias Estudios Clinicos SC
Culiacán, Sinaloa, 80020, Mexico
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Northwestern University
Chicago, Illinois, 60611, United States
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Oncocenter Oncologie Clinica S.R.L
Timișoara, Timiș County, 300166, Romania
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Oncocentro APYS
Viña del Mar, Valparaiso, 2520598, Chile
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Oncomed
Timișoara, Timiș County, 300239, Romania
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Oncosite Centro De Pesquisa Em Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
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One Clinical Research at Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
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Ongology Theageneio Thessaloniki
Thessaloniki, 54007, Greece
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Orlando Health
Orlando, Florida, 32806, United States
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Ozel Liv Hospital
Ankara, 06100, Turkey (Türkiye)
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Pan American Clinical Research
Guadalajara, Jalisco, 44670, Mexico
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Poznan University of Meidcla Science
Poznan, Wielkopolska, 60-788, Poland
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Preparaciones Oncologica SC
León, Guanajuato, 37178, Mexico
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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Radiotherapy Center Cluj
Floreşti, Cluj, 407280, Romania
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Royal Devon and Exeter Hospital NHS Trust
Exeter, Devon, EX2 5DW, United Kingdom
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Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
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Ruhr University Bochum
Bochum, North Rhine-Westphalia, 44791, Germany
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
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Saint Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
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Saint Louis Hospital
Paris, Île-de-France Region, 75010, France
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Sainte Catherine Institut du Cancer Avignon Provence
Avignon, 84918, France
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Santa Chiara Hospital
Trento, 38122, Italy
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Sao Camilo Oncologia
São Paulo, 04014-002, Brazil
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Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
Ankara, 06100, Turkey (Türkiye)
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Service de Dermatologie CHU Saint Eloi
Montpellier, Herault, 34295, France
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Sfantul Nectarie Oncology Center
Craiova, Dolj, 200347, Romania
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Sheba Medical Center
Tel Litwinsky, 5265601, Israel
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Skin Cancer Center Harz
Quedlinburg, Saxony-Anhalt, 06484, Germany
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St Lukes University Health Network
Easton, Pennsylvania, 18045, United States
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St Vincents University Hospital
Dublin, DO4YN63, Ireland
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Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
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TIM - Tbilisi Institute of Medicine
Tbilisi, 0160, Georgia
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Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA, United Kingdom
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Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Caucasus, 0144, Georgia
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Tennessee Oncology - Centennial Clinic Location
Nashville, Tennessee, 37203-1625, United States
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The Christie
Manchester, M20 4BX, United Kingdom
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The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
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The Melanoma And Skin Cancer Institute
Englewood, Colorado, 80113, United States
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The Ohio State University James Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
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Trakya University
Edirne, 22030, Turkey (Türkiye)
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U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)
Naples, Campania, 80121, Italy
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UC San Diego
La Jolla, California, 92093, United States
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UCK
Gdansk, Pomeranian Voivodeship, 80-214, Poland
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UCSF Medical Center at Mission Bay
San Francisco, California, 94158, United States
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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Unimed Sorocaba
Sorocaba, São Paulo, 18052-210, Brazil
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Universitatsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
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Universitatsklinikum Schleswig Holstein Campus Luebeck
Lübeck, Schleswig-Holstein, 23538, Germany
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University Clinic Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
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University College London Hospitals
London, NW1 2PG, United Kingdom
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University Hospital Augsburg
Augsburg, Bavaria, 86179, Germany
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University Hospital Coventry and Warwickshire Nhs Trust
Coventry, West Midlands, CV2 2DX, United Kingdom
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University Hospital Dresden
Dresden, Saxony, 01307, Germany
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University Hospital Hradec Kralove
Hradec Králové, North Central Czech Republic, 50005, Czechia
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University Hospital Muenster
Münster, North Rhine-Westphalia, 48149, Germany
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University Hospital Ostrava
Ostrava, 70852, Czechia
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University Hospital of Regensburg
Regensburg, Bavaria, 93053, Germany
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University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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University Medical Center Goettingen
Göttingen, Lower Saxony, 37075, Germany
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University Medical Center Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
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University Of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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University of Perugia
Perugia, 06132, Italy
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University of Rochester
Rochester, New York, 14642, United States
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University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
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University of Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
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University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
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Verdi Oncology
Nashville, Tennessee, 37203, United States
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Vitaz campus Sint-Niklaas Moerland
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
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Wilgers Oncology Centre
Pretoria, Gauteng, 0081, South Africa
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Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
Słupsk, Pomeranian Voivodeship, 76-200, Poland
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iCan Oncology
Monterrey, Nuevo León, 64710, Mexico
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