IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (PRISM-MEL-301)
February 23, 2026 updated by: Immunocore Ltd
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
680
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Immunocore Medical Information
- Phone Number: 844-466-8661
- Email: medical.information@immunocore.com
Study Contact Backup
- Name: Immunocore Medical Information EU
- Phone Number: +00 800-744-51111
- Email: medinfo.eu@immunocore.com
Study Locations
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Buenos Aires, Argentina, C1199ABD
- Recruiting
- Hospital Italiano de Buenos Aires (HIBA)
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CABA, Argentina, CP1426ANZ
- Recruiting
- Instituto Alexander Fleming
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Córdoba, Argentina, X5008HHW
- Recruiting
- CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
-
Contact:
- Dra. Laura Nardone
- Phone Number: 54 9 351 678-3938
- Email: lauranardone@cemaicsas.com.ar
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Viedma, Argentina, R8500ACE
- Recruiting
- Clinica Viedma
-
Contact:
- Ruben Kowalyszyn
- Phone Number: 542920601693
- Email: kowar@rnonline.com.ar
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Buenos Aires
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Caba, Buenos Aires, Argentina, 1213
- Recruiting
- Sanatorio Finochietto
-
Contact:
- Dr. Gabriela Cinat
- Phone Number: 541158216233
- Email: gabriela_cinat@yahoo.com.ar
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Caba, Buenos Aires, Argentina, C1430EGF
- Recruiting
- Clínica Adventista Belgrano - Sector Investigación
-
Contact:
- Aldo A. Perfetti
- Phone Number: 5491132682903
- Email: aaperfetti@yahoo.com.ar
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Heidelberg, Australia, 3084
- Recruiting
- Austin Hospital
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North Melbourne, Australia, 3051
- Recruiting
- Peter MacCallum Cancer Centre
-
Contact:
- Dr Lavinia Spain
- Phone Number: 61385595000
- Email: Enquiries.GMR@gallipoliresearch.org.au
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Wollstonecraft, Australia
- Recruiting
- University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre
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Woolloongabba, Australia
- Recruiting
- The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
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New South Wales
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Waratah, New South Wales, Australia, 02298
- Recruiting
- Calvary Mater Newcastle Hospital
-
Contact:
- MOR Clinical Trials
- Phone Number: (02) 40143280
- Email: Kim.Adler@calvarymater.org.au
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Queensland
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Greenslopes, Queensland, Australia, 4120
- Completed
- Gallipoli Medical Research Foundation (Greenslopes Private Hospital)
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Western Australia
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Nedlands, Western Australia, Australia, 06009
- Recruiting
- Linear Clinical Research
-
Contact:
- Anke Hoskins
- Phone Number: 61-8-6383 3189
- Email: Anke.Hoskins@health.wa.gov.au
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Nedlands, Western Australia, Australia, 06009
- Recruiting
- One Clinical Research - Nedlands
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Contact:
- Prof. Adnan Khattak
- Phone Number: +61 8 6279 9466
- Email: info@oneclinicalresearch.com.au
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Graz, Austria, 8036
- Recruiting
- LKH - Universitaetsklinikum Graz
-
Contact:
- Alexandra Rodlauer-Kriegl
- Phone Number: 43 31 638 580 169
- Email: alexandra.rodlauer-kriegl@medunigraz.at
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Pölten, Austria
- Recruiting
- Universitätsklinikum St. Pölten
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Salzburg, Austria, 5020
- Recruiting
- Paracelsus Medizinischen Privatuniversitaet - SALK - Universitaetsklinik fuer Dermatologie - EB-Haus Austria
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Vienna, Austria, 1090
- Recruiting
- AKH - Medizinische Universitat Wien
-
Contact:
- Prof. Höller Christoph
- Phone Number: 43 (0)1 40400 77310
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Anderlecht, Belgium, 01070
- Recruiting
- Universite Libre de Bruxelles (ULB)-Institut Jules Bordet
-
Contact:
- Dr. Langouo
- Phone Number: 00 32 2 541 33 77
- Email: m.langouofontsa@hubruxelles.be
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Bruges, Belgium, 8000
- Recruiting
- AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan
-
Contact:
- Angelique Slock
- Phone Number: 3250452849
- Email: angelique.slock@azsintjan.be
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Brussels, Belgium, 1090
- Recruiting
- Universitair Ziekenhuis Brussel
-
Contact:
- Loes De Koster
- Phone Number: 02 476 33 94
- Email: loes.dekoster@uzbrussel.be
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Brussels, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint-Luc - Institut Roi Albert II
-
Contact:
- Fontaine Florence
- Phone Number: 32 276 48 509
- Email: florence.fontaine@saintluc.uclouvain.be
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Leuven, Belgium, 03000
- Recruiting
- UZ Leuven
-
Contact:
- Trial AMO UZ Leuven
- Email: trialamo@uzleuven.be
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Barretos, Brazil, 14784
- Recruiting
- Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor
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Brasília, Brazil, DF CEP 70200-730
- Recruiting
- Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia
-
Contact:
- Cristiany de Jesus da Siva de Lima
- Phone Number: 55 61 2141 4856
- Email: cristiany.jslima@hsl.org.br
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Florianópolis, Brazil, 88034-000
- Recruiting
- Centro de Pesquisas Oncologicas (CEPON)
-
Contact:
- Camila Donadel
- Phone Number: +55 48 3331-1553
- Email: camila.donadel@cepon.org.br
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Fortaleza, Brazil, 60135-237
- Recruiting
- Oncocentro Sao Carlos Hospital
-
Contact:
- Diogenes Leite
- Phone Number: 55 85 30348677
- Email: diogenes.leite@idor.org
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Liberdade, Brazil, 01509-010
- Recruiting
- A.C.Camargo Cancer Center - Centro Internacional de Pesquisa (CIPE)
-
Contact:
- Guilherme Cavalcante Pessoa
- Phone Number: 2189-5000 (5138)
- Email: guilherme.cavalcante@accamargo.org.br
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Porto Alegre, Brazil, 90035-903
- Recruiting
- Hospital de Clinicas de Porto Alegre (HCPA)
-
Contact:
- Andrea Baldasso Zanon
- Phone Number: 55 51 3359-8619
- Email: abzanon.upco@gmail.com
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Contact:
- Sergio Jobim de Azevedo
- Phone Number: 55 51 3359-8619
- Email: sazevedo@hcpa.edu.br
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Porto Alegre, Brazil, 90610-000
- Recruiting
- Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas - Centro de Pesquisa Clinica (CPC)
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Contact:
- Virginia Webber
- Phone Number: 51 3320-3039
- Email: virginia.webber@cpors.com
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Rio de Janeiro, Brazil, 20220-410
- Recruiting
- National Cancer Institute
-
Contact:
- Andreia Cristina de Melo, MD
- Phone Number: +55 (21) 99173-9618
- Email: andreia.melo@inca.gov.br
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Rio de Janeiro, Brazil, 22775-001
- Recruiting
- Instituto Américas - Instituto de Educação Pesquisa e Gestão em Saúde Oncosite
-
Contact:
- Raphaela Lima, MD
- Phone Number: +5521 96845-7879
- Email: centrodepesquisa@institutoamericas.org
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São Paulo, Brazil, 01246-000
- Recruiting
- Instituto do Cancer do Estado de Sao Paulo (ICESP)
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São Paulo, Brazil, 01308-070
- Recruiting
- Hospital 9 De Julho
-
Contact:
- Rafael Shimerling
- Phone Number: 11 9948-3000
- Email: rafael.schmerling.ext@dasa.com.br
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São Paulo, Brazil, 15090-000
- Recruiting
- Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Centro Integrado de Pesquisa (CIP)
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Contact:
- Thamyres Arroyo
- Phone Number: +55 17 32015054
- Email: thamyres.cruz@centrodepesquisacip.com.br
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brazil, 98700-000
- Recruiting
- Centro de Pesquisa Clinica em Oncologia - Oncosite
-
Contact:
- Fábio André Franke
- Phone Number: 55 55 3195-0504
- Email: oncositeijui@gmail.com
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Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
- Recruiting
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA
-
Contact:
- Alan Azambuja, MD
- Phone Number: +55 51-33072943
- Email: cgi.pesquisa@gmail.com
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Panagyurishte, Bulgaria, 4500
- Recruiting
- Uni Hospital
-
Contact:
- Milena Kardaleva
- Phone Number: 359888844526
- Email: kardaleva@gmail.com
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Plovdiv, Bulgaria, 4000
- Recruiting
- Complex Oncology Center - Plovdiv Ltd.
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Sofia, Bulgaria
- Recruiting
- Regina Life Clinic
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Sofia, Bulgaria, 1527
- Recruiting
- University Hospital Tsaritsa Yoanna (ISUL) (Queen Giovanna University Hospital)
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Edmonton, Canada, T6G 1Z2
- Recruiting
- Cross Cancer Institute
-
Contact:
- Dr. John Walker, MD
- Phone Number: 780-577-8082
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Ontario
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Toronto, Ontario, Canada, M5G 2C1
- Recruiting
- Princess Margaret Cancer Centre
-
Contact:
- Marcus Butler, MD
- Phone Number: 5485 416-946-4501
- Email: marcus.butler@uhn.ca
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Hradec Králové, Czechia, 500 05
- Recruiting
- Fakultni Nemocnice Hradec Kralove (FNHK) - Klinika Onkologie a Radioterapie
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Contact:
- Jindřich Kopecký, PhD
- Phone Number: 42 0495834980
- Email: jindrich.kopecky@fnhk.cz
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Olomouc, Czechia, 77900
- Recruiting
- Fakultni Nemocnice Olomouc (FNOL)
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Contact:
- Bohuslav Melichar
- Phone Number: (+420)588444295
- Email: Bohuslav.Melichar@fnol.cz
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Prague, Czechia, 110 00
- Completed
- Sanatorium Profesora Arenbergera
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Herlev, Denmark, 2730
- Recruiting
- Kobenhavns Universitet - Herlev Hospital (Amtssygehuset i Herlev)
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Contact:
- Inge Marie Svane
- Phone Number: 004538362131
- Email: inge.marie.svane@regionh.dk
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Helsinki, Finland, 00290
- Recruiting
- Helsingin Yliopistollinen Keskussairaala - Cancercentrum
-
Contact:
- Micaela Hernberg, MD
- Phone Number: 00 35 850 4279 490
- Email: micaela.hernberg@hus.fi
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Tampere, Finland, 33520
- Recruiting
- Pirkanmaan Sairaanhoitopiiri (Pirkanmaa Hospital District)-Tampereen Yliopistollinen Sairaala (Tampere University Hospital)
-
Contact:
- Tanja Skyttä, MD
- Phone Number: 35 84 447 28790
- Email: tanja.skyttä@pirha.fi
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Turku, Finland, 20520
- Recruiting
- Turun Yliopistollinen Keskussairaala (TYKS)
-
Contact:
- Saana-Maaria Virtanen, MD
- Phone Number: 35 82 313 5090
- Email: saana.maaria.virtanen@varha.fi
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Bobigny, France, 93000
- Completed
- Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Seine-Saint-Denis - Hopital Avicenne
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Boulogne-Billancourt, France, 92104
- Recruiting
- Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare
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Caen, France, 14000
- Recruiting
- UNICANCER-Centre Francois Baclesse (CFB)
-
Contact:
- Dr Stefan Andreea, MD
- Phone Number: 33234455050
- Email: a.stefan@baclesse.unicancer.fr
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Dijon, France
- Recruiting
- CHU de Dijon Bourgogne - Hôpital François Mitterrand
-
Contact:
- Meryem DEBBABI
- Phone Number: 33380293842
- Email: meryem.debbabi@chu-dijon.fr
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Contact:
- Elisabeth CORNOT
- Phone Number: 33380669466
- Email: elisabeth.cornot@chu-dijon.fr
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Lille, France, 59037
- Recruiting
- Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez
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Contact:
- Pr Laurent Mortier
- Phone Number: 0033320444193
- Email: laurent.mortier@chu-lille.fr
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Nantes, France
- Recruiting
- Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
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Paris, France, 75010
- Recruiting
- Hospital Saint Louis
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Pierre-Bénite, France, 69310
- Recruiting
- Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
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Rouen, France, 76031
- Recruiting
- Centre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-Nicolle
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Contact:
- Orlane DEBOVES
- Phone Number: 0232886699
- Email: orlane.deboves@chu-rouen.fr
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Contact:
- Raphaëlle DAVESNE
- Phone Number: 0232886699
- Email: raphaelle.davesne@chu-rouen.fr
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Valence, France, 26000
- Recruiting
- Hopital Robert Debre
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Villejuif, France, 94800
- Recruiting
- Institut Gustave Roussy (IGR) Service de Dermatolgie
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Cedex
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Marseille, Cedex, France, 13385
- Recruiting
- Hopital de la Timone
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Toulouse, Cedex, France, 31059
- Recruiting
- Oncopole Claudius Regaud- Institut Universitaire du Cancer de Toulouse
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Berlin, Germany, 10115
- Recruiting
- Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)
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Contact:
- Max Schlaak, MD
- Phone Number: 4930450518448
- Email: studien-hauttumorcentrum@charite.de
-
Contact:
- Max Schlaak, MD
- Phone Number: 4930450518309
- Email: studien-hauttumorcentrum@charite.de
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Bremen, Germany, 28205
- Recruiting
- Klinikum Bremen-Ost gGmbH
-
Contact:
- Dr. Miriam Schiff
- Phone Number: 04 21-497 70452
- Email: miriam.schiff@gesundheitnord.de
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Dortmund, Germany, 44137
- Recruiting
- Klinikum Dortmund gGmbH - Klinikzentrum Mitte - Hautklinik
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Dresden, Germany, 01307
- Recruiting
- Universitätsklinikum Carl Gustav Carus
-
Contact:
- Daniela Walther
- Phone Number: 0049 351 458 19782
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Erfurt, Germany, 99089
- Recruiting
- Helios Klinikum Erfurt - Klinik fuer Hautkrankheiten und Allergologie
-
Contact:
- Prof. Dr. med. Rudolf A Herbst, MD
- Phone Number: 0361 781-4301
- Email: rudolf.herbst@helios-gesundheit.de
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Erlangen, Germany, 91054
- Recruiting
- Universitaetsklinikum Erlangen
-
Contact:
- Onkologische Studienzentrale der Hautklinik
- Phone Number: 09 131-854 5861
- Email: onkstudienzentrale.de@uk-erlangen.de
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Essen, Germany, 45122
- Recruiting
- Universitaetsklinikum Essen
-
Contact:
- Jessica Bauriedl
- Phone Number: 02017232325
- Email: Jessica.bauriedl@uk-essen.de
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Frankfurt, Germany, 60590
- Recruiting
- Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Dermatologie, Venerologie und Allergologie
-
Contact:
- Dr. Berenice Lang, MD
- Phone Number: 4969630183115
- Email: berenice.lang@unimedizin-ffm.de
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Giessen, Germany, D-35392
- Recruiting
- Justus-Liebig-Universitaet Giessen - Klinik fuer Dermatologie und Andrologie
-
Contact:
- Phone Number: (+)49641-985-43200
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Hamburg, Germany, 20246
- Recruiting
- University of Hamburg
-
Contact:
- Prof. Dr. Gebhardt
- Phone Number: 4940741057626
- Email: Studien-htz@uke.de
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Hamburg, Germany, 22045
- Recruiting
- Elbe Kliniken Stade - Hautkrebszentrum Buxtehude
-
Contact:
- Uta Haisch
- Phone Number: 4941617036212
- Email: Uta.Haisch@elbekliniken.de
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Heidelberg, Germany, 69120
- Recruiting
- Universitaetsklinikum Heidelberg (UKHD) - Hautklinik
-
Contact:
- Prof. Jessica Hassel, MD
- Phone Number: 496221568562
- Email: NCT.DermaOnko@med.uni-heidelberg.de
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Kiel, Germany, DE-24105
- Recruiting
- University Hospital Schleswig-Holstein
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Leipzig, Germany, 4103
- Recruiting
- Universitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und Allergologie
-
Contact:
- Jan Christoph Simon, MD
- Phone Number: 00493419718600
- Email: Jan.simon@medizin.uni-leipzig.de
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Mainz, Germany, D-55131
- Recruiting
- UNIVERSITAETSMEDIZIN der Johannes Gutenberg-Universitaet Mainz
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Contact:
- Jennifer Nostadt
- Phone Number: 49 6131 / 17-8412
- Email: birgit.huebscher@unimedizin-mainz.de
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Marburg, Germany, 35043
- Recruiting
- Universitaetsklinikum Giessen und Marburg GmbH - Marburg
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Minden, Germany, 32429
- Recruiting
- Johannes Wesling Klinikum Minden
-
Contact:
- Yenny Angela
- Phone Number: 57179054523
- Email: yenny.angela@muehlenkreiskliniken.de
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Munich, Germany, 81377
- Recruiting
- LMU Klinikum - Klinik und Poliklinik fur Dermatologie und Allergologie
-
Contact:
- Prof. Lucie Heinzerling, MD
- Phone Number: +4989440056326
- Email: DER.onko.studien@med.uni-muenchen.de
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Tübingen, Germany, 72076
- Recruiting
- Universitaetsklinikum Tuebingen (UKT) - Zentrum fuer Dermatoonkologie - Hautklinik
-
Contact:
- Teresa Amaral, MD, PhD
- Phone Number: 004970712985748
- Email: Teresa.amaral@med.uni-tuebingen.de
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Würzburg, Germany, 97080
- Recruiting
- Universitaetsklinikum Wuerzburg - Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie
-
Contact:
- Anja Gesierich, MD
- Phone Number: 4993120126762
- Email: Gesierich_A@ukw.de
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Budapest, Hungary, 1085
- Recruiting
- Semmelweis Egyetem Általános Orvostudományi Kar
-
Contact:
- Péter Holló, MD
- Phone Number: +36-20-8258870
- Email: hollo.peter@med.semmelweis-univ.hu
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Budapest, Hungary, 1122
- Recruiting
- Orszagos Onkologiai Intezet (National Institute of Oncology)
-
Contact:
- Dr. Tímea Balatoni, MD
- Phone Number: 36 30 990 9862
- Email: balatoni.timea@oncol.hu
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Debrecen, Hungary
- Recruiting
- Debreceni Egyetem-Klinikai Kozpont (DEKK)
-
Contact:
- Dr. Gabriella Emri, MD
- Phone Number: 36 30 437 4672
- Email: gemri@med.unideb.hu
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Pécs, Hungary, 7624
- Recruiting
- Pecsi Tudomanyegyetem (PTE) (University of Pecs)
-
Contact:
- Zsuzsanna Lengyel, MD
- Phone Number: 36303599887
- Email: lengyel.zsuzsanna@pte.hu
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Szeged, Hungary, 6720
- Recruiting
- Szegedi Tudomanyegyetem (University of Szeged)
-
Contact:
- Eszter Baltás, MD
- Phone Number: +36-303468499
- Email: ebaltas@gmail.com
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Bari, Italy, 70124
- Recruiting
- Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
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Bergamo, Italy, 24125
- Recruiting
- Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A)
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Meldola, Italy, 47014
- Recruiting
- IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)
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Milan, Italy, 20141
- Recruiting
- Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
-
Contact:
- Raffaella Ghisini
- Email: raffaella.ghisini@ieo.it
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Milan, Italy, 20133
- Recruiting
- Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
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Modena, Italy, 41124
- Recruiting
- Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena - Day Hospital Oncologico
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Napoli, Italy, 80131
- Recruiting
- Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di Napoli
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Padua, Italy, 35128
- Recruiting
- Istituto Oncologico Veneto (IOV) IRCCS
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Padua, Italy, I-35128
- Recruiting
- Istituto Oncologico Veneto (IOV) IRCCS
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Perugia, Italy, 06129
- Recruiting
- Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
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Ponderano, Italy, 13875
- Recruiting
- Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli Infermi
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Roma, Italy, 0168
- Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Roma, Italy, 00128
- Recruiting
- National Cancer Institute Regina Elena
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Siena, Italy, 53100
- Recruiting
- " Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica"
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Torino, Italy, 10126
- Recruiting
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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Kaunas, Lithuania, 50161
- Recruiting
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
-
Contact:
- Rima Adomaitiene
- Phone Number: 37 06 010 5626
- Email: rima.deltuvaite@gmail.com
-
Vilnius, Lithuania, LT-08406
- Recruiting
- Vilnius University Hospital Santaros Clinics Affiliate National Cancer Center
-
Contact:
- Aiste Sukstiene
- Phone Number: 37 05 274 6459
- Email: aiste.sukstiene@nvc.santa.lt
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Mexico City, Mexico, 04701
- Recruiting
- Centro Oncologico Internacional(COI) - Ciudad de Mexico
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Jalisco
-
Guadalajara, Jalisco, Mexico, 44280
- Recruiting
- Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
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Bergen, Norway, 05009
- Recruiting
- Haukeland University Hospital
-
Contact:
- Cornelia Schuster, MD
- Phone Number: 4755972010
- Email: cornelia.schuster@helse-bergen.no
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Oslo, Norway, 0379
- Recruiting
- Oslo University Hospital
-
Contact:
- Anna Winge-Main
- Phone Number: +47 452 59938
- Email: annwi@ous-hf.no
-
-
-
-
-
Bydgoszcz, Poland, 85796
- Completed
- Centrum Onkologii im. Prof. Franciszka Łukaszczyka
-
Gdansk, Poland, 80-214
- Recruiting
- Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
-
Contact:
- Izabela Gudewicz
- Email: izabelagudewicz@gumed.edu.pl
-
Skorzewo, Poland, 60185
- Completed
- Centrum Medyczne Pratia Poznan - Skorzewo
-
Warsaw, Poland, 02-781
- Recruiting
- Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
-
Contact:
- Beata Wielgocka
- Phone Number: 225462603
- Email: beata.wielgocka@pib-nio.pl
-
-
-
-
-
Coimbra, Portugal, 3004-561
- Recruiting
- Centro Hospitalar e Universitario de Coimbra EPE (CHUC)
-
Lisbon, Portugal, 1099-023
- Recruiting
- Instituto Portugues de Oncologio de Lisboa Francisco Gentil EPE (IPO Lisboa) (IPOLFG)
-
Contact:
- Dr. Patricia Pereira
- Phone Number: 35 1 21 722 9892
- Email: pmsilva@ipolisboa.min-saude.pt
-
Lisbon, Portugal, 1649-035
- Recruiting
- Hospital Lusiadas Lisboa (HPP Hospital Dos Lusiadas)
-
Contact:
- Sofia Torres, MD
- Email: sofia.torres@chln.min-saude.pt
-
-
-
-
-
Cluj-Napoca, Romania, 400015
- Recruiting
- L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN) (The Oncology Institute Prof. Dr. Ion. Chiricuta)
-
Contact:
- Dana Iancu
- Phone Number: 40 745 364 514
- Email: dana_iancu2004@yahoo.com
-
Craiova, Romania, 200542
- Recruiting
- Sf Nectarie Oncology Center
-
Contact:
- Augustin Gheorghe
- Phone Number: 40723557512
- Email: gusti.gheorghe@yahoo.com
-
Iași, Romania, 700106
- Recruiting
- Victoria Hospital (Centrul de oncologie Euroclinic SRL) (Centrul De Oncologie Medicala) (Euroclinic Onchology Center)
-
Contact:
- Constantin Volovat, MD
- Phone Number: 40 746 110 096
- Email: cvolovat@gmail.com
-
-
-
-
-
A Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruña (CHUAC)
-
Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall D'Hebron
-
Barcelona, Spain, 8036
- Recruiting
- Hospital Clinic de Barcelona
-
Contact:
- Nadina Fradera
- Phone Number: 0034687727943
- Email: fradera@recerca.clinic.cat
-
Barcelona, Spain, 08908
- Recruiting
- Hospital Duran i Reynals
-
Barcelona, Spain, 08035
- Recruiting
- Hospital Universitario Dexeus
-
Córdoba, Spain, 14004
- Recruiting
- Hospital Universitario Reina Sofia
-
Contact:
- Manuel Sánchez Ostos
-
Contact:
- Phone Number: 957 002 343
- Email: manuel.sanchez.oncologia@gmail.com
-
Granada, Spain, 18014
- Recruiting
- Hospital Universitario Virgen de las Nieves (HUVN)
-
Contact:
- Isabel Rodriguez
- Phone Number: 179591 0034 958 145 591
- Email: i_rodriguez_gonzalez@hotmail.es
-
Las Palmas de Gran Canaria, Spain, 35016
- Recruiting
- Hospital Universitario Insular de Gran Canaria
-
Contact:
- Fatima Guillen Suarez
- Phone Number: 34 92 841 738
- Email: uecchuimi.scs@gobiernodecanarias.org
-
Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon Y Cajal
-
Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
-
Contact:
- Yolanda Álvarez Pérez
- Phone Number: 917277516
- Email: yolandalapaz@gmail.com
-
Madrid, Spain, 28009
- Recruiting
- Hospital General Universitario Gregorio Marañon
-
Contact:
- Isabel Cañete
- Phone Number: 0034 914268161
- Email: icg.hgugm@gmail.com
-
Madrid, Spain, 28050
- Recruiting
- Centro Integral Oncológico Clara Campal (CIOCC)
-
Madrid, Spain, 28027
- Recruiting
- Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
-
Contact:
- Sara Diaz Sánchez
- Phone Number: 7604 0034 913 531 920
- Email: sdiazsanch@unav.es
-
Madrid, Spain, 28041
- Recruiting
- Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)
-
Contact:
- Guillermo de Velasco
- Phone Number: 913908003
- Email: gdvelasco.gdv@gmail.com
-
Málaga, Spain, 29016
- Recruiting
- Hospital Regional Universitario de Malaga
-
Contact:
- Irene Rojas
- Phone Number: 0034 608093004
- Email: ensayosch@yahoo.es
-
Pamplona, Spain, 31008
- Recruiting
- Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
-
Contact:
- Eduardo De la Guardia
- Phone Number: 0034 948 296 666 + 2736
- Email: edelaguardia@unav.es
-
Reus, Spain, 43204
- Recruiting
- Hospital Universitari Sant Joan De Reus
-
Contact:
- Francisca Martínez Madueño
- Phone Number: (+34) 664 300 708
- Email: francisca.martinez@salutsantjoan.cat
-
San Sebastián, Spain, 20014
- Recruiting
- Onkologikoa - Kutxaren Institutu Onkologikoa (Instituto Oncologico De Guipuzcoa)
-
Contact:
- Ainhoa Arocena
- Phone Number: 94 332 8315
-
Contact:
- Lidia Nieto
- Phone Number: 94 332 8315
-
Seville, Spain, 41013
- Recruiting
- Hospital Universitario Virgen Del Rocio
-
Seville, Spain, 41009
- Recruiting
- Hospital Universitario Virgen Macarena
-
Contact:
- Mónica Suengas
- Phone Number: 697958425
- Email: moni.suengas@gmail.com
-
Valencia, Spain, 46026
- Recruiting
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
-
Contact:
- Maite Giralt
- Phone Number: 34 638 037 641
- Email: sconcologia@iislafe.es
-
Contact:
- Phone Number: 34 96 124 41 88
-
Valencia, Spain, 46014
- Recruiting
- Hospital Clinico Universitario de Valencia
-
Valencia, Spain, 46010
- Recruiting
- Instituto de Investigacion Sanitaria (INCLIVA) (Institute of Health Research Hospital Clinic of Valencia)
-
Contact:
- Inés González Barrallo, MD
- Phone Number: +34 961 973 517
- Email: igbarrallo@gmail.com
-
Zaragoza, Spain, 50009
- Recruiting
- Servicio Aragones de Salud - Hospital Universitario Miguel Servet (HUMS)
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Recruiting
- Universidad de Cantabria (UC) - Hospital Universitario Marques de Valdecilla (HUMV)
-
Contact:
- Marta Sotelo
- Phone Number: 73351 942 20 33 51
- Email: marta.sotelo@scsalud.es
-
-
Murcia
-
El Palmar, Murcia, Spain, 30120
- Recruiting
- Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA)
-
Contact:
- Paula Ruiz Carreño
- Phone Number: 0034968369387
- Email: dm.oncoarrixaca2@gmail.com
-
-
-
-
-
Gothenburg, Sweden, SE41345
- Recruiting
- Sahlgrenska Akademin - Institutionen for Kliniska Vetenskaper (Institute of Clinical Sciences)
-
Jönköping, Sweden, 553 05
- Recruiting
- Lanssjukhuset Ryhov - Onkologiska Kliniken
-
Contact:
- Bo Thelin
- Phone Number: 46102425943
- Email: bo.thelin@rjl.se
-
Lund, Sweden, 22185
- Recruiting
- Skanes Universitetssjukhus - Lund - Onkologiska Klinik
-
Stockholm, Sweden, 171 76
- Recruiting
- Karolinska Universitetssjukhuset
-
Contact:
- Amanda Hallgren
- Phone Number: +46 08-123-717-91
- Email: amanda.hallgren@regionstockholm.se
-
Uppsala, Sweden, SE75185
- Recruiting
- Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)
-
-
-
-
-
Zurich, Switzerland, 8901
- Recruiting
- UniversitaetsSpital Zuerich - Dermatologische Klinik
-
Contact:
- Prof. Dr. med Reinhard Dummer, MD
- Phone Number: 41442552507
- Email: Reinhard.dummer@usz.ch
-
-
-
-
-
Altındağ, Turkey (Türkiye), 6230
- Recruiting
- Kanser Enstitusu (Hacettepe University Cancer Institute)
-
Ankara, Turkey (Türkiye), 6100
- Recruiting
- T.C. Saglik Bakanligi - SBU Gulhane Egitim ve Arastirma Hastanesi
-
Contact:
- Dr Nuri Karadurmus
- Phone Number: +90 536 640 10 20
- Email: drnkaradurmus@yahoo.com
-
Malatya, Turkey (Türkiye), 44280
- Recruiting
- Inonu Universitesi - Turgut Ozal Tip Merkezi
-
Contact:
- Mustafa Dikilitas
- Phone Number: 0533 572 01 75
- Email: dikilitasmd@yahoo.com
-
Samsun, Turkey (Türkiye), 55270
- Recruiting
- Ondokuz Mayis Universitesi (OMU) - Tip Facultesi
-
Contact:
- Bahiddin Yilmaz
- Phone Number: 0532 599 28 25
- Email: yilmazbahiddin80@gmail.com
-
Seyhan, Turkey (Türkiye), 1140
- Recruiting
- Medical Park Seyhan Hastanesi
-
Contact:
- Ahmet Sezer
- Phone Number: +90 533 361 69 39
- Email: drasezer@hotmail.com.tr
-
Yenimahalle, Turkey (Türkiye), 06170
- Recruiting
- T.C. Saglik Bakanligi - Ankara Etlik sehir Hastanesi
-
Contact:
- Nilay Ertunc Cayan
- Phone Number: +90 536 640 10 20
- Email: nilay.ertunc@medismart.com.tr
-
Çankaya, Turkey (Türkiye), 6800
- Recruiting
- Ankara Bilkent City Hospital, Oncology Department
-
-
Adana
-
Yüreğir, Adana, Turkey (Türkiye), 1370
- Recruiting
- T.C. Saglik Bakanligi - Adana Numune Egitim ve Arastirma Hastanesi (Adana Numune Education and Research Hospital)
-
Contact:
- Sevilay Demircioglu
- Phone Number: 90 554 861-2028
- Email: sevilay.demircioglu@ebmresearch.com
-
-
Ankara
-
Çankaya, Ankara, Turkey (Türkiye), 06520
- Recruiting
- Memorial Saglik Grubu - Memorial Ankara Hastanesi
-
Contact:
- Umut Demirci
- Phone Number: 0506 752 12 75
- Email: drumutdemirci@gmail.com
-
-
Antalya
-
Kepez, Antalya, Turkey (Türkiye), 7025
- Recruiting
- Memorial Antalya Hastanesi
-
Contact:
- Ali Murat Tatli, MD
- Phone Number: 00 90 532 7115 637
- Email: alimurattat@hotmail.com
-
-
Campus
-
Antalya, Campus, Turkey (Türkiye), 07070
- Recruiting
- Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
-
Contact:
- Ali Murat Tatli
- Email: alimurattat@hotmail.com
-
-
Gaziantep
-
Şehitkamil, Gaziantep, Turkey (Türkiye), 27584
- Recruiting
- Medical Park Gaziantep Hastanesi
-
Contact:
- Alper Sevinc, MD
- Phone Number: 0555 241 46 87
- Email: alpersevinc27@hotmail.com
-
-
Istanbul
-
Bahçelievler, Istanbul, Turkey (Türkiye), 34180
- Recruiting
- Memorial Saglik Grubu - Memorial Bahcelievler Hastanesi
-
Contact:
- Hakan Harputluoglu
-
-
İzmir
-
Bornova, İzmir, Turkey (Türkiye), 35100
- Recruiting
- Ege Universitesi Tip Fakultesi (Ege University Faculty of Medicine)
-
Contact:
- Fulden Saraç
- Phone Number: 53 09 672 608
- Email: fulden.sarac@atlascro.com.tr
-
Cordaleo, İzmir, Turkey (Türkiye), 35575
- Recruiting
- Izmir Ekonomi Universitesi Medikal Point Hastanesi
-
Contact:
- Cagatay Arslan, MD
- Phone Number: 505 264 2353
- Email: arslancagatay@yahoo.com
-
-
-
-
-
Birmingham, United Kingdom, B15 2TH
- Recruiting
- Queen Elizabeth Hospital Birmingham
-
Cambridge, United Kingdom, CB20QQ
- Recruiting
- Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) - Oncology Centre
-
Glasgow, United Kingdom, G12 0YN
- Recruiting
- Beatson West of Scotland Cancer Centre
-
Contact:
- Dr Pavlina Spiliopoulou, MD
- Phone Number: 0141 301 7043
- Email: pavlina.spiliopoulou2@nhs.scot
-
Liverpool, United Kingdom, L78YA
- Recruiting
- The Clatterbridge Cancer Centre NHS Foundation Trust
-
Contact:
- Pembe Yeslidag
- Phone Number: 01515565435
- Email: pembe.yesildag@nhs.net
-
London, United Kingdom, W1G 6AD
- Completed
- Sarah Cannon Research Institute (SCRI) - London (SCRI-UK)
-
Manchester, United Kingdom, M204BX
- Recruiting
- The Christie NHS Foundation Trust
-
Oxford, United Kingdom, Ox37LE
- Recruiting
- University of Oxford
-
Contact:
- Dr Miranda Payne, MD
- Phone Number: 01 865 74 1841
-
Surrey Quays, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden Hospital - Sutton
-
-
-
-
Arizona
-
Tucson, Arizona, United States, 85720
- Recruiting
- University of Arizona
-
Contact:
- Terri Katz
- Phone Number: 520-621-2029
- Email: tkatz@arizona.edu
-
-
California
-
La Jolla, California, United States, 92093-0698
- Recruiting
- University of California - San Diego
-
Contact:
- Katie O'Neil
- Phone Number: 858-822-6575
- Email: croneil@health.ucsd.edu
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA Hematology/Oncology
-
Contact:
- Jessica Crocker
- Phone Number: 310-794-3266
- Email: JCrocker@mednet.ucla.edu
-
Los Angeles, California, United States, 90025
- Recruiting
- The Angeles Clinic and Research Institute- West Los Angeles
-
Contact:
- Saba Mukarram
- Phone Number: 310-231-2181
- Email: smukarram@theangelesclinic.org
-
Los Angeles, California, United States, 90033
- Recruiting
- ESC Norris Comprehensive Cancer Center
-
Contact:
- Sandy Tran
- Phone Number: 323-865-3935
- Email: Sandy.Tran@med.usc.edu
-
Palo Alto, California, United States, 94304
- Completed
- Stanford Cancer Institute - Stanford Cancer Center Palo Alto
-
Santa Monica, California, United States, 90404
- Recruiting
- Saint John's Health Center - John Wayne Cancer Institute (JWCI)
-
Contact:
- Maribel Ramirez
- Phone Number: 310-582-7457
- Email: maribel.ramirez1@providence.org
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado, Anschutz Medical Campus
-
Contact:
- Kayla Vondran
- Phone Number: 720-848-9381
- Email: KAYLA.VONDRAN@CUANSCHUTZ.EDU
-
Denver, Colorado, United States, 80222
- Recruiting
- The Melanoma & Skin Cancer Institute
-
Contact:
- Brandon Keith
- Phone Number: 303-777-2663
- Email: bkeith@westernstatesncorp.org
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030-2205
- Completed
- UConn Health-Farmington (University of Connecticut Health Center (UCHC))
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20007
- Recruiting
- Georgetown University
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Recruiting
- Mayo Clinic Florida
-
Contact:
- Heidi Turner
- Phone Number: 904-953-5323
- Email: Turner.Heidi@mayo.edu
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami
-
Contact:
- Email: CRSCutaneous@miami.edu
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI
-
-
Kansas
-
Westwood, Kansas, United States, 66205
- Recruiting
- The University of Kansas Cancer Center (KUCC) - Westwood
-
Contact:
- CT Nurse Navigator
- Phone Number: 913-945-7552
- Email: CTNurseNav@kumc.edu
-
-
Kentucky
-
Edgewood, Kentucky, United States, 41017
- Recruiting
- St. Elizabeth Healthcare - Edgewood
-
Contact:
- Elizabeth Beatty, CRC
- Phone Number: 859-301-4243
- Email: Elizabeth.Beatty@stelizabeth.com
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Kamaneh Montazeri, MD
- Phone Number: 617-724-4000
- Email: kmontazeri@mgh.harvard.edu
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana Farber Cancer Institute
-
Contact:
- Linnea Drew
- Phone Number: 617-632-6704
- Email: Linneam_drew@dfci.harvard.edu
-
-
Michigan
-
Detroit, Michigan, United States, 04820
- Recruiting
- Henry Ford Cancer Center - Michigan
-
Contact:
- Bethany Adams
- Phone Number: 248-224-7345
- Email: badams19@HFHS.ORG
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55407
- Recruiting
- Allina Health Cancer Institute - Minneapolis
-
Contact:
- Jonathan Alexander
- Phone Number: 612-863-8625
- Email: jonathan.alexander@allina.com
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Completed
- Washington University School of Medicine
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- John Theurer Cancer Center at Hackensack University Medical Center
-
Contact:
- Oncology Clinical Research Referral Office
- Phone Number: 551-996-1777
- Email: OncologyResearchReferral@hmhn.org
-
-
New York
-
Lake Success, New York, United States, 11042
- Recruiting
- Northwell Health Cancer Institute
-
Contact:
- Sarilee Liz
- Email: sliz@northwell.edu
-
New York, New York, United States, 10032
- Completed
- Columbia University Medical Center
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University
-
Contact:
- Sierra Cimafranca
- Phone Number: 614-685-1911
- Email: Sierra.Cimafranca@osumc.edu
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University
-
Contact:
- Madeleine Martinelli
- Phone Number: 267-414-8820
- Email: Madeleine.martinelli@jefferson.edu
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- UPMC Hillman Cancer Center
-
Contact:
- Kelly Schroder
- Phone Number: 412-623-3544
- Email: schroderka@upmc.edu
-
-
South Carolina
-
Greenville, South Carolina, United States, 29605
- Recruiting
- Prisma Health Cancer Institute
-
Contact:
- Lisa Johnson
- Email: Lisa.johnson@prismahealth.org
-
Spartanburg, South Carolina, United States, 29303
- Recruiting
- Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC)
-
Contact:
- Kristen Ford, RN MSN
- Phone Number: 864-530-6554
- Email: kford@gibbscc.org
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37920
- Recruiting
- The University of Tennessee - Knoxville (UTK)
-
Contact:
- Megan McKenzie, RN
- Phone Number: 865-305-6284
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Tennessee Oncology, PLLC
-
Contact:
- Mindy Jordan
- Phone Number: 888-555-2835
- Email: mejordan@tnonc.com
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon Research Institute: USA/TN
-
-
Texas
-
Dallas, Texas, United States, 75235-9179
- Recruiting
- University of Texas Southwestern
-
Contact:
- Desiree Pierre
- Phone Number: 214-645-9830
- Email: Desiree.Pierre@utsouthwestern.edu
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- University of Utah Huntsman Cancer Institute
-
Contact:
- Shantae George
- Phone Number: 801-213-8486
- Email: shantae.george@hci.utah.edu
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Recruiting
- UVA Health-UVA Emily Couric Clinical Cancer Center
-
Contact:
-
Richmond, Virginia, United States, 23298-0070
- Recruiting
- Virginia Commonwealth University (VCU) - Massey Cancer Center
-
Contact:
- Faith McFadden
- Phone Number: 804-628-0616
- Email: masseyskinca@vcu.edu
-
-
Washington
-
Seattle, Washington, United States, 98104
- Recruiting
- Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus
-
Contact:
- CancerResearch
- Phone Number: 206-215-3125
- Email: cancerresearch@swedish.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants must be HLA-A*02:01-positive
- Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
- Archived or fresh tumor tissue sample that must be confirmed as adequate
- Participants must have measurable disease per RECIST 1.1
- Participant must have BRAF V600 mutation status determined
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
Exclusion Criteria:
- Participants with a history of a malignant disease other than those being treated in this study
- Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- Participants with clinically significant pulmonary disease or impaired lung function
- Participants with clinically significant cardiac disease or impaired cardiac function
- Participants with active autoimmune disease requiring immunosuppressive treatment
- Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm C: Nivolumab OR Nivolumab + Relatlimab
Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.
|
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Other Names:
Concentrate for solution for infusion at a unit dose of 16 mg/mL.
Other Names:
|
|
Experimental: Arm A: Brenetafusp Low Dose + Nivolumab
Participants receive brenetafusp Low Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W. Closed to randomization after dose recommendation by the IDMC in November 2025. |
Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL.
Other Names:
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Other Names:
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Experimental: Arm B: Brenetafusp High Dose + Nivolumab
Participants receive brenetafusp High Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W. Selected as go-forward experimental arm after dose recommendation by the IDMC in November 2025 |
Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL.
Other Names:
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Progression-Free Survival (PFS)
Time Frame: Up to ~45 months
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PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
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Up to ~45 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maximum Plasma Concentration (Cmax) of IMC-F106C
Time Frame: Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
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The Cmax of IMC-F106C will be reported.
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Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
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Overall Survival (OS)
Time Frame: Up to ~57 months
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OS is the time from randomization to time of death from any cause.
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Up to ~57 months
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Overall Response Rate (ORR)
Time Frame: Up to ~45 months
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ORR as assessed by BICR according to RECIST 1.1.
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Up to ~45 months
|
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Number of Participants Experiencing ≥1 Adverse Event (AE)
Time Frame: Up to ~57 months
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An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur in the study.
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Up to ~57 months
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Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)
Time Frame: Up to ~57 months
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An SAE is any untoward medical consequence that results in death; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or any other important medical event in the opinion of the Investigator.
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Up to ~57 months
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Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation
Time Frame: Up to ~45 months
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The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.
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Up to ~45 months
|
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Incidence of anti-IMC-F106C Antibodies
Time Frame: Up to ~45 months
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The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.
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Up to ~45 months
|
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Association between PFS and Intra-Tumor Immune Cells
Time Frame: Up to ~45 months
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The potential association between the effect of IMC-F106C on efficacy and intra-tumor environment will be explored.
Intra-tumor environment is estimated as the ratio of CD3+ to CD163+ cells and the correlation with PFS will be estimated by the hazard ratio (+/- 95% CI) from a Cox model.
This analysis will be restricted to subjects randomized to receive IMC-F106C.
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Up to ~45 months
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Health-Related Quality of Life
Time Frame: Up to ~45 months
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The change from baseline over time and between treatments of health-related quality of life will be reported.
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Up to ~45 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2024
Primary Completion (Estimated)
October 16, 2027
Study Completion (Estimated)
October 16, 2027
Study Registration Dates
First Submitted
October 19, 2023
First Submitted That Met QC Criteria
October 31, 2023
First Posted (Actual)
November 1, 2023
Study Record Updates
Last Update Posted (Actual)
February 25, 2026
Last Update Submitted That Met QC Criteria
February 23, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Skin Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Skin Neoplasms
- Melanoma
- Amino Acids, Peptides, and Proteins
- Proteins
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Nivolumab
- relatlimab
- Opdualag
Other Study ID Numbers
- IMC-F106C-301
- 2023-505306-42 (Other Identifier: EU CT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.