Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
May 6, 2026 updated by: Eikon Therapeutics
A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma (TeLuRide-006)
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants with Advanced Melanoma.
The study includes dose optimization and expansion parts.
Study Type
Interventional
Enrollment (Estimated)
740
Phase
- Phase 2
- 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: Krishna Kaza
- Phone Number: +1 (516) 675-6163
- Email: Kazak@eikontx.com
Study Contact Backup
- Name: Juliette Beaulieu
- Phone Number: 415-940-4170
- Email: beaulieuj@eikontx.com
Study Locations
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New South Wales
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Wollongong, New South Wales, Australia, 2500
- Recruiting
- Cancer Care Wollongong
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Contact:
- Sue Parker
- Phone Number: +61 242439708
- Email: Sparker@cancercarewollongong.com.au
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Contact:
- Tabetha Gibson
- Email: TGibson@cancercarewollongong.com.au
-
Principal Investigator:
- Daniel Brungs
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-
Queensland
-
Chermside, Queensland, Australia, 4032
- Recruiting
- Icon Cancer Centre Chermside
-
Contact:
- Jesse Peet
- Phone Number: +07 3737 4539
- Email: Jesse.Peet@icon.team
-
Contact:
- Amy Goh
- Phone Number: +0438597944
- Email: amy.goh@icon.team
-
Principal Investigator:
- Chun Gan
-
-
South Australia
-
Bedford Park, South Australia, Australia, 5042
- Recruiting
- Southern Adelaide Local Health Network Incorporated Flinders Medical Centre
-
Principal Investigator:
- Amitesh Roy
-
Contact:
- Alex Scott-Hoy
- Phone Number: 08 8204 4485
- Email: alex.scott-hoy@sa.gov.au
-
Contact:
- Alessia Belperio
- Phone Number: (08) 8204 5054
- Email: alessia.belperio@sa.gov.au
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Victoria
-
Box Hill, Victoria, Australia, 3128
- Recruiting
- Eastern Health
-
Contact:
- LaiWan Reid
- Phone Number: +61 474 871 676
- Email: laiwan.reid@monash.edu
-
Principal Investigator:
- Phillip Parente
-
Sub-Investigator:
- Zhen R Siow
-
Frankston, Victoria, Australia, 3199
- Recruiting
- Peninsula and South Eastern Haematology and Oncology Group
-
Principal Investigator:
- Vinod Ganju
-
Contact:
- Albert Goikhman
- Phone Number: +61 422510299
- Email: ag@paso.com.au
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-
-
-
Styria
-
Graz, Styria, Austria, 8036
- Recruiting
- Universitätsklinikum Graz
-
Contact:
- Alexandra Rodlauer-Kriegl
- Phone Number: +43 316385 80169
- Email: alexandra.rodlauer-kriegl@medunigraz.at
-
Principal Investigator:
- Ingrid Wolf
-
Sub-Investigator:
- Christiane Mutz-Rabl
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Sint-Niklaas, Belgium, 9100
- Recruiting
- Vitaz Primary Location
-
Principal Investigator:
- Ines Deleu
-
Contact:
- Luna Van Hoyweghen
- Phone Number: +32 3760 7627
- Email: luna.vanhoyweghen@vitaz.be
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-
Antwerpen
-
Edegem, Antwerpen, Belgium, 2650
- Recruiting
- Universitair Ziekenhuis Antwerpen
-
Principal Investigator:
- Marika Rasschaert
-
Contact:
- Sandrine Harzé
- Phone Number: +3234368354
- Email: sandrine.harze@uza.be
-
Contact:
- Valerie Stragier
- Phone Number: +32 3 436 8091
- Email: valerie.stragier@uza.be
-
Sub-Investigator:
- Timon Vandamme
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-
Brussels Capital
-
Brussels, Brussels Capital, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint-luc
-
Contact:
- Louise Favaretto
- Phone Number: +32 2 764 35 13
- Email: louise.favaretto@saintluc.uclouvain.be
-
Contact:
- Beatriz Busine
- Phone Number: +32 2 764 13 31
- Email: guichetcommercial@saintluc.uclouvain.be
-
Principal Investigator:
- Jean-François Baurain Baurain
-
Sub-Investigator:
- Frank Cornelis
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Namur
-
Yvoir, Namur, Belgium, B-5530
- Recruiting
- Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
-
Contact:
- Mathilde Parmentier
- Phone Number: +32 0 81 42 38 57
- Email: mathilde.parmentier@chuuclnamur.uclouvain.be
-
Contact:
- Geraldine Mineur
- Phone Number: +32 81 42 38 55
- Email: geraldine.mineur@uclouvain.be
-
Principal Investigator:
- Laurence Faugeras
-
Sub-Investigator:
- Quentin Gilliaux
-
-
Vlaams Brabant
-
Leuven, Vlaams Brabant, Belgium, 3000
- Recruiting
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
-
Contact:
- Loulou Dourée
- Phone Number: +32 16 34 39 44
- Email: loulou.douree@uzleuven.be
-
Contact:
- Marjolein Dom
- Phone Number: +32 16 34 59 91
- Email: marjolein.dom@uzleuven.be
-
Principal Investigator:
- Oliver Bechter
-
Sub-Investigator:
- Patrick Schöffski
-
-
West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgium, 8500
- Recruiting
- Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
-
Contact:
- Inge Meyer
- Phone Number: +32 56 63 39 40
- Email: inge.meyer@azgroeninge.be
-
Contact:
- Angel Remmerie
- Phone Number: +32 56 63 39 75
- Email: cta.oncologie@azgroeninge.be
-
Principal Investigator:
- Veronique Buyse
-
Sub-Investigator:
- Tine Loyson
-
-
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Research Ins<tute
-
Principal Investigator:
- Rossanna Pezo
-
Contact:
- Stephanie Lewaniak
- Phone Number: 689957 +1 416-480-5000
- Email: stephanie.lewaniak@sunnybrook.ca
-
Contact:
- Carolyn Lim
- Phone Number: 67219 +1 416-480-5000
- Email: carolyn.lim@sunnybrook.ca
-
Sub-Investigator:
- Teresa Petrella
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-
-
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Brno
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Brno, Brno, Czechia, 65653
- Recruiting
- Masaryk Memorial Cancer Institute
-
Contact:
- Hana Blahynkova
- Phone Number: +420 543 136 233
- Email: hana.blahynkova@mou.cz
-
Principal Investigator:
- Radek Lakomy
-
Sub-Investigator:
- Svatopluk Dobeš
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-
Hradce Kralove
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Sokolov, Hradce Kralove, Czechia, 50009
- Recruiting
- University hospital Hradec Králové
-
Principal Investigator:
- Jindrich Kopecky
-
Contact:
- Klara Reznickova
- Phone Number: +420495832849
- Email: klara.reznickova@fnhk.cz
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-
-
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Central Jutland
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Aarhus, Central Jutland, Denmark, 8200
- Recruiting
- Aarhus Universitetshospital
-
Contact:
- Line M Sparvath
- Phone Number: +45 27512026
- Email: linspa@rm.dk
-
Contact:
- Lone Dall
- Phone Number: +45 9116 7216
- Email: lone.dall@auh.rm.dk
-
Principal Investigator:
- Henrik Schmidt
-
Sub-Investigator:
- Louise M Guldbrandt
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-
Nord Jutland
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Aalborg, Nord Jutland, Denmark, 9000
- Recruiting
- Aalborg University Hospital
-
Contact:
- Lotte Andersen
- Phone Number: +4599661290
- Email: loba@rn.dk
-
Contact:
- Celine Nielsen
- Phone Number: +4520259874
- Email: celine.nielsen@rn.dk
-
Principal Investigator:
- Adam Luczak
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-
-
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Oulu
-
Oulu, Oulu, Finland, 90230
- Recruiting
- Oulu University Hospital
-
Contact:
- Raija Mikkonen
- Phone Number: +358405057872
- Email: raija.mikkonen@pohde.fi
-
Principal Investigator:
- Sanna Livanainen
-
-
Pirkanmaa
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Tampere, Pirkanmaa, Finland, 33521
- Recruiting
- Tampere University Hospital
-
Contact:
- Marjo Koivisto
- Phone Number: +358444728004
- Email: marjo.koivisto@pirha.fi
-
Principal Investigator:
- Tanja Skyttä
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Uusimaa
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Helsinki, Uusimaa, Finland, 00029
- Recruiting
- Helsinki University Hospital
-
Contact:
- Jacoba Peterson-Hirvonen
- Phone Number: +358-50-372 9043
- Email: jacoba.peterson-hirvonen@hus.fi
-
Principal Investigator:
- Micaela Hernberg
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-
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Bordeaux, France, 33075
- Recruiting
- Hospital Saint Andre
-
Contact:
- Gaelle Domingo
- Phone Number: +33557820655
- Email: gaelle.domingo@chu-bordeaux.fr
-
Principal Investigator:
- Caroline Dutriaux
-
-
Auvergne-Rhône-Alpes
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Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
- Recruiting
- Centre hospitalier Lyon-Sud
-
Principal Investigator:
- Stéphane Dalle
-
Contact:
- Caroline Marchi
- Phone Number: +33 04 78 86 33 35
- Email: caroline.marchi@chu-lyon.fr
-
-
Boulogne
-
Boulogne, Boulogne, France, 92104
- Recruiting
- A Paré
-
Principal Investigator:
- Philippe Saiag
-
Contact:
- Veronique Clerisse
- Phone Number: +33618458154
- Email: veronique.clerisse@aphp.fr
-
Contact:
- Marine Masson
- Phone Number: +33 1 49 09 52 75
- Email: marinesuzanne.masson@aphp.fr
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-
Isère
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La Tronche, Isère, France, 38700
- Recruiting
- Centre Hospitalier Universitaire Grenoble Alpes
-
Principal Investigator:
- Julie Charles
-
Contact:
- Stéphane Mouret
- Phone Number: +33476767081
- Email: smouret1@chu-grenoble.fr
-
-
Lille Cedex
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Polonovski, Lille Cedex, France, 59037
- Recruiting
- Chu Lille
-
Principal Investigator:
- Laurent MORTIER
-
Contact:
- Léa Malvoisin
- Phone Number: +33320446415
- Email: lea.malvoisin@chu-lille.fr
-
Contact:
- Sara Aliouane
- Phone Number: +33320443597
- Email: sara.aliouane@chu-lille.fr
-
-
Marseille
-
Marseille, Marseille, France, 13385
- Recruiting
- Hôpital la Timone
-
Contact:
- Kahina DJENAD-ICHALLAL
- Phone Number: +33 0491 38 88 03
- Email: Kahina.DJENAD@ap-hm.fr
-
Principal Investigator:
- Caroline Gaudy
-
-
PACA
-
Nice, PACA, France, 06200
- Recruiting
- Centre Hospitalier Universitaire (CHU) Nice
-
Principal Investigator:
- Henri Montaudié
-
Contact:
- Emmanuelle Pradelli
- Phone Number: +33492036667
- Email: pradelli.e@chu-nice.fr
-
-
Paris
-
Paris, Paris, France, 75018
- Recruiting
- Hôpital Bichat AP-HP Université Paris Cité
-
Contact:
- Sabrina Djerroud
- Phone Number: +33 1 40 25 64 63
- Email: sabrina.djerroud@aphp.fr
-
Principal Investigator:
- Florence Brunet-Possenti
-
-
Pays de la Loire Region
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Saint-Herblain, Pays de la Loire Region, France, 44800
- Recruiting
- ICO Saint Herblain
-
Contact:
- Caoline Perrault
- Phone Number: +33 2 40 67 99 1
- Email: caroline.perrault@ico.unicancer.fr
-
Contact:
- Elodie Planchais
- Phone Number: +33 2 40 67 99 00
- Email: elodie.planchais@ico.unicancer.fr
-
Principal Investigator:
- Mélanie Saint-Jean
-
-
Rouen
-
Rouen, Rouen, France, 76031
- Recruiting
- CHU Rouen
-
Contact:
- Elodie Geant
- Phone Number: 6 66 99 (33) 02 32 88 66 99
- Email: elodie.geant@chu-rouen.fr
-
Principal Investigator:
- Anne Benedicte Duval Modeste
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-
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-
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Münster, Germany, 48157
- Recruiting
- Fachklinik Hornheide
-
Principal Investigator:
- Carmen Loquai
-
Contact:
- Konigkamp Romina
- Phone Number: +49 251 32 87 505
- Email: romina.koenigkamp@fachklinik-hornheide.de
-
-
Baden-Wurttemberg
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Mannheim, Baden-Wurttemberg, Germany, 68167
- Recruiting
- Universitätsmedizin Mannheim
-
Principal Investigator:
- Jochen Utikal
-
Contact:
- Katharina Thuene
- Phone Number: +49 621 383-3993
- Email: katharina.thuene@dkfz-heidelberg.de
-
Tübingen, Baden-Wurttemberg, Germany, 72076
- Recruiting
- Universitaetsklinikum Tuebingen (UKT)
-
Contact:
- Melanie Peter
- Phone Number: +49 7071 29 84555
- Email: melanie.peter@med.uni-tuebingen.de
-
Principal Investigator:
- Andreas Meiwes
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-
Bavaria
-
Würzburg, Bavaria, Germany, 97080
- Recruiting
- Klinik für Dermatologie, Venerologie und Allergologie
-
Contact:
- Jana Riederer
- Phone Number: +49 931-201-26762
- Email: riederer_j@ukw.de
-
Contact:
- Sandra Hupfloher
- Phone Number: +49 931 201 26762
- Email: hasseli_s@ukw.de
-
Principal Investigator:
- Anja Gesierich
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-
Free and Hanseatic City of Hamburg
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Martinsried, Free and Hanseatic City of Hamburg, Germany, 20246
- Recruiting
- Universitätsklinik Hamburg Eppendorf
-
Principal Investigator:
- Christoffer Gebhardt
-
Contact:
- Christin Seeger
- Phone Number: +49 15222800599
- Email: c.seeger@uke.de
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Leipzig
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Saxony, Leipzig, Germany, 04103
- Recruiting
- Universität Leipzig
-
Contact:
- Silke Weidauer-Zuniga
- Phone Number: +493419718750
- Email: silke.weidauer-zuniga@medizin.uni-leipzig.de
-
Contact:
- Christin Pavlović
- Phone Number: +49 341 97 18380
- Email: christin.pavlovic@medizin.uni-leipzig.de
-
Principal Investigator:
- Jan Christoph Simon
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Lower Saxony
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Buxtehude, Lower Saxony, Germany, 21614
- Recruiting
- Elbe Kliniken Stade-Buxtehude
-
Principal Investigator:
- Peter Mohr
-
Contact:
- Lioba Starp
- Phone Number: +4941617036212
- Email: Lioba.starp@elebekliniken.de
-
Contact:
- Uta Haisch
- Email: uta.haisch@elbekliniken.de
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North Rhine-Westphalia
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Minden, North Rhine-Westphalia, Germany, 32429
- Recruiting
- Johannes Wesling Klinikum Minden
-
Contact:
- Helge Wuttig
- Phone Number: +49-(0)571-790-54528
- Email: helge.wuttig@muehlenkreiskliniken.de
-
Principal Investigator:
- Ralf Gutzmer
-
-
RLP
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Mainz, RLP, Germany, 55131
- Recruiting
- University of Mainz Medical Center
-
Principal Investigator:
- Stephan Grabbe
-
Contact:
- Claudia Bauer
- Phone Number: +496131175147
- Email: claudia.bauer@unimedizin-mainz.de
-
Contact:
- Susanne Wagner
- Email: Susanne.Wagner2@unimedizin-mainz.de
-
-
Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24105
- Recruiting
- Universitätsklinikum Schleswig-Holstein - Campus Kiel
-
Contact:
- Frauke Westermann
- Phone Number: +49 431 500 21133
- Email: fwestermann@dermatology.uni-kiel.de
-
Contact:
- Corinna Schirmann
- Phone Number: +49 431 500 21136
- Email: cschirmann@dermatology.uni-kiel.de
-
Principal Investigator:
- Katharina Kähler
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Lübeck, Schleswig-Holstein, Germany, 23538
- Recruiting
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
-
Contact:
- Jenny Koop
- Phone Number: +49 451 500 41570
- Email: jenny.koop@uksh.de
-
Contact:
- Beate Gehrt
- Phone Number: +49 451 500 41570
- Email: beate.gehrt@uksh.de
-
Principal Investigator:
- Evelyn Gaffal
-
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State of Berlin
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Berlin, State of Berlin, Germany, 10115
- Recruiting
- Charite Department of Dermatology, Venereology and Allergology
-
Principal Investigator:
- Thomas Eigentler
-
Contact:
- Nurcan Uzun
- Phone Number: +49 30 450 518 448
- Email: nurcan.uzun@charite.de
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Pécs, Hungary, 7632
- Recruiting
- University of Pecs
-
Contact:
- Andrea Morvane Kiss
- Phone Number: +3672-536-882
- Email: morvane.andrea@pte.hu
-
Principal Investigator:
- Zsuzsanna Lengyel
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Budapest
-
Budapest, Budapest, Hungary, 1122
- Recruiting
- National Institute of Oncology
-
Contact:
- Barbara Varga
- Phone Number: +36204553579
- Email: varga.barbara@oncol.hu
-
Principal Investigator:
- Timea Balatoni
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Be'er Sheva
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Beersheba, Be'er Sheva, Israel, 8410101
- Recruiting
- Soroka Medical Center
-
Contact:
- Margarita Boltian
- Phone Number: 972 8-6403375
- Email: margaritabol@clalit.org.il
-
Principal Investigator:
- Alexander Yakobson
-
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Petach Tikva
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Petah Tikva, Petach Tikva, Israel, 4941492
- Recruiting
- Rabin Medical Center
-
Contact:
- Noa Konvalina
- Phone Number: +97239378077
- Email: noakon@clalit.org.il
-
Principal Investigator:
- Nethanel Asher
-
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Ramat Gan
-
Ramat Gan, Ramat Gan, Israel, 5262100
- Recruiting
- Ella Lemelbaum Institute for Immuno-Oncology and Melanoma
-
Contact:
- Osnat Mazuz
- Phone Number: +972 35307916
- Email: osnat.mazuz@sheba.health.gov.il
-
Principal Investigator:
- Ronnie Shapira-Frommer
-
Sub-Investigator:
- Raz Mutai
-
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Tel Aviv
-
Tel Aviv, Tel Aviv, Israel, 6423906
- Recruiting
- Tel Aviv Medical Center
-
Contact:
- Hagit Damchiner-Pearl
- Phone Number: 972-52-7360519
- Email: hagitdp@tlvmc.gov.il
-
Principal Investigator:
- Mor Miodovnik
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Milano
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Milan, Milano, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele
-
Contact:
- Nicola Fogale
- Phone Number: +39 02 2643 9024
- Email: fogale.nicola@hsr.it
-
Principal Investigator:
- Vincenzo Russo
-
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Province of Bergamo
-
Bergamo, Province of Bergamo, Italy, 24125
- Recruiting
- Humanitas Gavazzeni Bergamo
-
Contact:
- Paola Maggioni
- Phone Number: +39 0354204760
- Email: paola.maggioni@gavazzeni.it
-
Principal Investigator:
- Laura Pala
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The Marches
-
Ancona, The Marches, Italy, 60126
- Recruiting
- Clinica Oncologia Delle Marche
-
Principal Investigator:
- Rossana Berardi
-
Contact:
- Alessandra Lucarelli
- Phone Number: +39 071 5965093
- Email: alessandra.lucarelli@ospedaliriuniti.marche.it
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Tuscany
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Siena, Tuscany, Italy, 53100
- Recruiting
- UOC Immunoterapia Oncologica
-
Contact:
- Elisa Ibba
- Phone Number: +39 577586056
- Email: elisa.ibba@ao-siena.toscana.it
-
Principal Investigator:
- Anna Maria Di Giacomo
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Christchurch
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Christchurch, Christchurch, New Zealand, 8011
- Recruiting
- Christchurch Public Hospital
-
Contact:
- Katharine Moore
- Phone Number: +64 2740 66867
- Email: Katharine.Moore@cdhb.health.nz
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Principal Investigator:
- David Gibbs
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New Zealand
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Auckland, New Zealand, New Zealand, 1023
- Recruiting
- Auckland City Hospital
-
Contact:
- Jessica Lalanne
- Phone Number: 21837 +64 9 3074949
- Email: jlalanne@adhb.govt.nz
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Contact:
- Ruta Padalkar
- Phone Number: +64 9 3074949
- Email: RutaP@adhb.govt.nz
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Principal Investigator:
- Gareth Rivalland, MD
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Bodø
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Bodø, Bodø, Norway, N-8005
- Recruiting
- Nordland Hospital Trust
-
Contact:
- Petter Øien
- Phone Number: +47 75599133
- Email: petter.oien@nlsh.no
-
Principal Investigator:
- Bard Mannsaker
-
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Oslo
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Oslo, Oslo, Norway, 0310
- Recruiting
- Oslo University Hospital - The Norwegian Radium Hospital
-
Contact:
- Kirsten Hagene
- Phone Number: +47 99293273
- Email: kihage@ous-hf.no
-
Principal Investigator:
- Marta Nyakas
-
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Oslofjord
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Drammen, Oslofjord, Norway, 3004
- Recruiting
- Drammen Hospital
-
Contact:
- Siri Bråthen
- Phone Number: +47 32862464
- Email: siri.brathen@vestreviken.no
-
Sub-Investigator:
- Alina Carmen Porojnicu
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Gdańsk
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Gdansk, Gdańsk, Poland, 80-952
- Recruiting
- Uniwersyteckie Centrum Kliniczne
-
Contact:
- Elżbieta Kurzawa
- Phone Number: +48517331593
- Email: ekurzawa@uck.gda.pl
-
Principal Investigator:
- Kamil Drucis
-
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Konin
-
Konin, Konin, Poland, 62-500
- Recruiting
- Prezychodnia Lekarska KOMED Roman Karaszewski
-
Principal Investigator:
- Bogusława Karaszewska
-
Contact:
- Dorota Pospieszynska
- Phone Number: +48632406136
- Email: d.pospieszynska45@gmail.com
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Siedlce
-
Siedlce, Siedlce, Poland, 08-110
- Recruiting
- Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii
-
Principal Investigator:
- Lubomir Bodnar
-
Contact:
- Tomasz Milewski
- Phone Number: +48600173523
- Email: tmilewski@szpital.siedlce.pl
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Warsaw
-
Warsaw, Warsaw, Poland, 02-781
- Recruiting
- Maria Sklodowska-Curie National Cancer Research Institute
-
Contact:
- Anna Gluszcz
- Phone Number: +48 22 546 26 03
- Email: anna.gluszcz@nio.gov.pl
-
Principal Investigator:
- Anna Czarnecka
-
-
-
-
Lisbon District
-
Lisbon, Lisbon District, Portugal, 1500-650
- Recruiting
- Hospital da Luz Lisboa
-
Contact:
- Catarina Aleixo
- Phone Number: 44659 +351.217.104.544
- Email: caleixo@hospitaldaluz.pt
-
Contact:
- Filipa Nunes
- Phone Number: 44660 +351 217 104 400
- Email: filipa.nunes@luzsaude.pt
-
Principal Investigator:
- Gonçalo Fernandes
-
Lisbon, Lisbon District, Portugal, 1099-023
- Recruiting
- Ipo Lisboa
-
Contact:
- Bruna Pavia
- Phone Number: +35 933464102
- Email: bpavia@ipolisboa.min-saude.pt
-
Principal Investigator:
- Patricia Pereira
-
-
-
-
Belgrade
-
Belgrade, Belgrade, Serbia, 11000
- Recruiting
- Military Medical Academy- Department of Oncology
-
Contact:
- Vesna Nesic
- Phone Number: +381641452888
- Email: vesnanesic8@gmail.com
-
Principal Investigator:
- Lidija Kandolf
-
-
-
-
Eastern Cape
-
Port Elizabeth, Eastern Cape, South Africa, 6045
- Recruiting
- Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre
-
Contact:
- Anna Szőke
- Phone Number: +36 209529 303
- Email: aszoke@ledgerrun.com
-
Principal Investigator:
- John Crockett
-
Sub-Investigator:
- Sakina Bawa
-
-
Gauteng
-
Pretoria, Gauteng, South Africa, 0002
- Recruiting
- University of Pretoria, Steve Biko Academic Hospital
-
Principal Investigator:
- Richard Khanyile
-
Contact:
- Venolia Mohlabine
- Phone Number: +27 12 354 2022
- Email: Venolia.Mohlabine@up.ac.za
-
Saxonwold, Gauteng, South Africa, 2196
- Recruiting
- The Medical Oncology Centre of Rosebank
-
Contact:
- Teresa Smit
- Phone Number: 0027828805944
- Email: data@rapoport.co.za
-
Principal Investigator:
- Bernardo Rapoport
-
-
KwaZulu-Natal
-
Richards Bay, KwaZulu-Natal, South Africa, 3900
- Recruiting
- Abraham Oncology
-
Principal Investigator:
- Smitha Abraham
-
Contact:
- Debbie Jacobs
- Phone Number: +27 347800247
- Email: debbie@drabraham.co.za
-
-
Pretoria
-
Pretoria, Pretoria, South Africa, 0084
- Recruiting
- Curo Oncology
-
Contact:
- Lenore Dirker
- Phone Number: +27 12 335 6771
- Email: research@curo-oncology.co.za
-
Principal Investigator:
- Rouchelle Marais-Nieman
-
-
Western Cape
-
Cape Town, Western Cape, South Africa, 7570
- Recruiting
- Cape Town Oncology Trials
-
Principal Investigator:
- Corlia Coetzee
-
Contact:
- Theo Niemand
- Phone Number: +27 (0)71 129 1765
- Email: theo.niemand@ctot.co.za
-
Contact:
- Pieter Laubscher
- Phone Number: +27 (0)82 748 3608
- Email: pieter.laubscher@ctot.co.za
-
Sub-Investigator:
- Johann Riedemann
-
George Central, Western Cape, South Africa, 6530
- Recruiting
- TASK Eden
-
Contact:
- Pieter Lennox
- Phone Number: +27 (0) 82 853 4991
- Email: pieter@task.org.za
-
Contact:
- Susanna Loock
- Phone Number: +27 72 423 4763
- Email: sumaria.l@task.org.za
-
Principal Investigator:
- Louis Botha
-
Sub-Investigator:
- Alista Easton
-
-
-
-
Daegu
-
Buk-Gu, Daegu, South Korea, 41404
- Recruiting
- Kyungpook National University Chilgok Hospital
-
Principal Investigator:
- Soo Jung Lee
-
Contact:
- Soon Im Lee
- Phone Number: +82 53 200 3177
- Email: silee@knuh-ext.kr
-
-
Seoul
-
Jongno-gu, Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
-
Principal Investigator:
- Jeonghwan Youk
-
Contact:
- Jiyoo Jung
- Phone Number: (+82) 01046433169
- Email: jiyoo8843@snu.ac.kr
-
-
-
-
Badalona
-
Badalona, Badalona, Spain, 08916
- Recruiting
- H. Germans Trias I Pujol (ICO-Badalona)
-
Contact:
- Laura Millares Costas
- Phone Number: +34 677254583
- Email: lmillares@iconcologia.net
-
Principal Investigator:
- José Manzano
-
-
Barcelona
-
Barcelona, Barcelona, Spain, 08028
- Recruiting
- Hospital Universitari Dexeus
-
Contact:
- Carlos Esparre
- Phone Number: +34 93 54 60 143
- Email: cesparre@oncorosell.com
-
Contact:
- Marta Juan
- Phone Number: +34 93 54 60 143
- Email: mjuan@oncorosell.com
-
Principal Investigator:
- Maria G Cao
-
Sub-Investigator:
- Josep S Ortega
-
Barcelona, Barcelona, Spain, 08035
- Recruiting
- Vall d' Hebron Institute of Oncology
-
Contact:
- Alba Barrio
- Phone Number: 8827 (+34) 93 254 34 50
- Email: bbruno@vhio.net
-
Contact:
- Núria Llansana
- Phone Number: 5063 (+34) 93 254 3450
- Email: nfarras@vhio.net
-
Principal Investigator:
- Eva M Couselo
-
-
Cáceres
-
Cáceres, Cáceres, Spain, 10003
- Recruiting
- San Pedro de Alcántara Hospital
-
Contact:
- Julia Cruces González
- Phone Number: +34 927256406
- Email: julia.crucesgonzalez@externos.salud-juntaex.es
-
Principal Investigator:
- Pablo Ayala
-
-
Galicia
-
Lugo, Galicia, Spain, 27003
- Recruiting
- Hospital Universitario Lucus Augusti
-
Contact:
- Raquel Romero
- Phone Number: +34 982 296459
- Email: raquel.romero.van.der.schoot@sergas.es
-
Principal Investigator:
- Begona Campos Balea
-
-
Girona
-
Girona, Girona, Spain, 17007
- Recruiting
- Institut Català d'Oncologia Girona (ICO Girona)
-
Principal Investigator:
- Pilar Barretina
-
Contact:
- Begoña M Castillo
- Phone Number: +34 972 22 58 28
- Email: bmartin@iconcologia.net
-
Contact:
- Bruna Castilhos
- Email: nmartin@iconcologia.net
-
Sub-Investigator:
- Anna Carbó
-
-
Jerez de La Frontera (Cádiz)
-
Jerez de La Frontera (Cádiz), Jerez de La Frontera (Cádiz), Spain, 11407
- Recruiting
- University Hospital of Jerez
-
Contact:
- Mari Carmen Leon
- Phone Number: +34 956 03 22 44
- Email: carmen.oncojerez@gmail.com
-
Principal Investigator:
- Regina Garcia Galindo
-
-
Madrid
-
Madrid, Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañon
-
Contact:
- Isabel Cañete
- Phone Number: 915868161
- Email: icg.hgugm@gmail.com
-
Principal Investigator:
- IVAN MARQUEZ
-
Madrid, Madrid, Spain, 28002
- Recruiting
- GenesisCare Madrid - Hospital San Francisco de Asís
-
Contact:
- Araceli Rodriguez
- Phone Number: +34 916219256
- Email: arodriguez.oncologytrials@gmail.com
-
Principal Investigator:
- José Angel Garcia Cuesta
-
Madrid, Madrid, Spain, 28050
- Recruiting
- HM CIOCC
-
Contact:
- Paloma Vargas Durán
- Phone Number: +4814 +34 91 756 78 00
- Email: pvargas@hmhospitales.com
-
Principal Investigator:
- Juan Rodriguez Moreno
-
Usera, Madrid, Spain, 28031
- Recruiting
- Hospital 12 de Octubre
-
Contact:
- Maria Jesus Perez Lorenzo
- Phone Number: +34913908547
- Email: startup.oncology.imas12@h12o.es
-
Principal Investigator:
- Guillermo De Velasco
-
-
Malaga
-
Málaga, Malaga, Spain, 29011
- Recruiting
- Hospital Regional Universitario
-
Contact:
- Irene Rojas García
- Phone Number: +34 608093004
- Email: ensayosch@yahoo.es
-
Principal Investigator:
- Miguel Angel Berciano
-
-
Málaga
-
Málaga, Málaga, Spain, 29010
- Recruiting
- Hospital Universitario Virgen de la Victoria
-
Contact:
- Desireeh Fernandez
- Phone Number: +34 951032508
- Email: desireeh.fernandez@ibima.eu
-
Principal Investigator:
- Manuel Zalabardo
-
-
Valencia
-
Valencia, Valencia, Spain, 46009
- Recruiting
- IVO - Fundacion Instituto Valenciano de Oncologia
-
Principal Investigator:
- Maria Jose Juan Fita
-
Contact:
- Raquel Bayona
- Phone Number: 671429340
- Email: datamanager33@fincivo.org
-
Contact:
- Belen Vazquez
- Phone Number: 663224875
- Email: coordinacion@fincivo.org
-
Sub-Investigator:
- Eduardo Nagore
-
Valencia, Valencia, Spain, 46010
- Recruiting
- INCLIVA Instituto de Investigación Sanitaria
-
Sub-Investigator:
- Valentina Gambardella
-
Contact:
- Paqui Fernandez
- Phone Number: 436696 +34) 96 197 35 00
- Email: ffernandez@incliva.es
-
Contact:
- Paloma Campos
- Phone Number: +34 682 43 47 08
- Email: pcampos@incliva.es
-
Principal Investigator:
- Ines G Barrallo
-
-
-
-
Gävleborg County
-
Gävle, Gävleborg County, Sweden, 801 88
- Recruiting
- Gavle Sjukhus
-
Contact:
- Ulrika Åsenlund
- Phone Number: +46 722077689
- Email: ulrika.asenlund@regiongavleborg.se
-
Principal Investigator:
- Ilke Cikman
-
Sub-Investigator:
- Olga Del Val Munoz
-
-
Södermanland County
-
Stockholm, Södermanland County, Sweden, 17176
- Recruiting
- Karolinska University Hospital
-
Contact:
- Johanna Lofberg Betts
- Phone Number: +46 8 12373388
- Email: johanna.lofberg-betts@regionstockholm.se
-
Principal Investigator:
- Hannah Eriksson
-
-
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Switzerland, 8091
- Recruiting
- Universitatsspital Zurich
-
Principal Investigator:
- Egle Ramelyte
-
Contact:
- Lucien Morel
- Phone Number: +41 44 255 18 59
- Email: lucien.morel@usz.ch
-
Contact:
- Julia Püschel
- Phone Number: +41 44 255 9485
- Email: julia.pueschel@usz.ch
-
Sub-Investigator:
- Michele Welti
-
-
Chur
-
Chur, Chur, Switzerland, 7000
- Recruiting
- Kantonsspital Graubunden
-
Contact:
- Gabriela Manetsch
- Phone Number: +41812566860
- Email: gabriela.manetsch@ksgr.ch
-
Principal Investigator:
- Roger von Moos
-
-
-
-
Belfast
-
Belfast, Belfast, United Kingdom, BT9 7AB
- Recruiting
- Belfast City Hospital, Belfast Health and Social Care Trust
-
Contact:
- Eimear Nicholl
- Phone Number: 47412 +4428 9504 7412
- Email: Eimear.nicholl@belfasttrust.hsc
-
Principal Investigator:
- Bode Oladipo
-
-
England
-
London, England, United Kingdom, SE1 9RT
- Recruiting
- Guy's and St Thomas' NHS Foundation Trust
-
Contact:
- Rumana Parvin
- Phone Number: 57422 020 7188 7188
- Email: rumana.parvin@gstt.nhs.uk
-
Contact:
- Taiwo Oguntoyinbo
- Phone Number: 82019/57422 020 7188 2019
- Email: taiwo.guntoyinbo@gstt.nhs.uk
-
Principal Investigator:
- Alvin Lee
-
London, England, United Kingdom, W1G6AD
- Recruiting
- Sarah Cannon Research Institute London
-
Principal Investigator:
- Anja Williams
-
Contact:
- Sebastian Agredo
- Phone Number: +44 203 219 5211
- Email: Sebastian.Agredo@hcahealthcare.co.uk
-
Sub-Investigator:
- Elisa Fontana
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO32 2DA
- Recruiting
- University Hospital Southampton
-
Contact:
- Connie Temple-Brown
- Phone Number: +44 2380777222
- Email: constance.temple-brown@uhs.nhs.uk
-
Principal Investigator:
- Matthew Wheater
-
-
-
-
Arizona
-
Chandler, Arizona, United States, 85224
- Recruiting
- Ironwood Cancer & Research Centers
-
Contact:
- Tiffany Wales
- Phone Number: 27104 480-256-1372
- Email: TIffany.Walas@ironwoodcrc.com
-
Principal Investigator:
- Amikar Sehdev, MD
-
-
Arkansas
-
Hot Springs, Arkansas, United States, 71913
- Recruiting
- Genesis Cancer and Blood Institute
-
Principal Investigator:
- Robert Muldoon
-
Contact:
- Laura Sellers
- Phone Number: 63839 5016247700
- Email: Laura.Sellers@aoncology.com
-
-
California
-
Los Angeles, California, United States, 90015
- Recruiting
- Helios Clinical Research
-
Principal Investigator:
- Pamela Miel
-
Contact:
- Sabrina Mora
- Phone Number: 562-735-3226
- Email: Sabrinamora@theoncologyinstitute.com
-
Contact:
- Leslie Posadas
- Email: leslieposadas@theoncologyinstitute.com
-
Santa Rosa, California, United States, 95403
- Recruiting
- Providence Medical Foundation
-
Principal Investigator:
- David Park
-
Sub-Investigator:
- Natalie Valle
-
Contact:
- Linda Gozar
- Phone Number: 4332 +1 714-992-3000
- Email: Linda.Gozar@stjoe.org
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80909
- Recruiting
- UCHealth Memorial Hospital Central
-
Contact:
- Ashley Miller
- Phone Number: 719-365-5062
- Email: ashley.miller5@uchealth.org
-
Principal Investigator:
- Stacey ParkerBrueggemann, MD
-
-
Florida
-
Hialeah, Florida, United States, 33013
- Recruiting
- BioResearch Partner
-
Contact:
- Tahimi Campa
- Phone Number: 833-489-4968
- Email: tdelacampa@bioresearchpartner.com
-
Contact:
- Mabel Cruz
- Phone Number: 833-489-4968
- Email: mcruz@bioresearchpartner.com
-
Principal Investigator:
- Luis Rangel
-
-
Maryland
-
Bethesda, Maryland, United States, 20817
- Recruiting
- The Center for Cancer and Blood Disorders
-
Principal Investigator:
- Victor Priego
-
Contact:
- Taylor Stutzman
- Phone Number: 301-571-2016
- Email: taylor.stutzman@aoncology.com
-
-
Missouri
-
Kansas City, Missouri, United States, 64132
- Recruiting
- MidAmerica Cancer Care
-
Principal Investigator:
- Jaswinder Singh
-
Contact:
- Logan Marney
- Phone Number: 833-886-1725
- Email: Logan.Marney@aoncology.com
-
St Louis, Missouri, United States, 63108
- Recruiting
- Washington University School of Medicine in St. Louis
-
Principal Investigator:
- George Ansstas
-
Contact:
- Kelsey Etter
- Phone Number: 314-273-0656
- Email: etter@wustl.edu
-
Sub-Investigator:
- Nicole Chrisman
-
-
Ohio
-
Canton, Ohio, United States, 44718
- Recruiting
- Gabrail Cancer Center Research LLC
-
Principal Investigator:
- Nashat Gabrail
-
Contact:
- Carrie Smith
- Phone Number: 330-417-8231
- Email: csmith@gabrailcancercenter.com
-
Sub-Investigator:
- Carmen Baldwin
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- University of Pittsburgh Medical Center(UPMC)-Hillman Cancer Center
-
Principal Investigator:
- Diwakar Davar, MD
-
Contact:
- Danielle Bednarz
- Phone Number: 412 623-1191
- Email: bednarzdl@upmc.edu
-
-
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:
To be eligible for inclusion in this study, participants must:
- Be ≥ 18 years of age on the day of signing of informed consent.
- Have a life expectancy of at least 3 months.
- Have histologically or cytologically confirmed Stage 3 (unresectable) or Stage 4 metastatic melanoma per AJCC 8th ed. and be eligible for standard therapy with pembrolizumab.
- Have at least 1 lesion with measurable disease at Baseline by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by assessment of local site Investigator/radiologist.
- Have known BRAF V600 mutation status or consent to BRAF V600 mutation testing per local institutional standards during the screening period
- Have completed prior radiotherapy at least 2 weeks prior to study treatment administration.
- Have an ECOG Performance Status of 0 to 1.
- Have adequate organ and marrow function as defined by normal CBC, coagulation, serum chemistry and liver function tests on specimens collected within 10 days of treatment start.
- Have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication (applies to women of childbearing potential [WOCBP]).
- Be willing to use either 2 adequate methods of contraception, 1 adequate method plus a hormonal method of contraception, or be willing to abstain from heterosexual activity throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to WOCBP who are not menopausal for > 2 years, post-hysterectomy/oophorectomy, or surgically sterilized).
- Agree to use an approved adequate contraceptive method throughout the study (Visit 1 to 120 days after the last dose of study therapy; applies to sexually active male participants with a partner who is WOCBP).
- Be willing and able to provide written, informed consent for the study.
Exclusion Criteria:
A participant is excluded from the study if any of the following criteria apply:
- Has melanoma of ocular origin.
- Is currently enrolled in or has recently participated in a study of an IMP and received an IMP within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001 or placebo.
- Prior to the 1St dose of EIK1001 or placebo, the prospective participant has received systemic therapy for advanced melanoma.
- Note: prior adjuvant or neoadjuvant melanoma therapies (such as anti-PD-1 or anti CTLA 4 therapies or BRAF/MEK inhibitors) are permitted if all related AEs have either returned to Baseline or stabilized, with a minimum of 6 months between the last dose of prior therapy and documented disease progression.
- Experienced a ≥ Grade 3 AE while receiving prior anti PD 1 therapy.
- Has had major surgery (< 3 weeks prior to the first dose).
- Has received a live-virus vaccination within 30 days of the first dose of study treatment.
- Has a known history of prior malignancy, unless the participant has undergone potentially curative therapy with no evidence of disease recurrence for 5 years.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if they are clinically stable for at least 4 weeks with no evidence of new or enlarging brain metastases. There must be no need for immunosuppressive doses of glucocorticoids for at least 2 weeks prior to study treatment administration.
- There is a mean resting QTcF > 470 ms on triplicate electrocardiograms.
- There is active autoimmune disease that has required systemic treatment in the past 2 years. The following autoimmune conditions are permitted: Type 1 diabetes, hypothyroidism (on hormone replacement), or- vitiligo, psoriasis and alopecia as long as no systemic treatment is required.
- There is either chronic treatment with systemic steroids, other immunosuppressive medication, or either of these has been administered within 14 days of start of study treatment.
- Note: Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections are eligible. Steroid replacement for adrenal insufficiency is also permitted.
- There is a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/ interstitial lung disease.
- There are any active infections requiring therapy.
- There is uncontrolled human immunodeficiency virus (HIV) infection. HIV-infected participants with well-controlled HIV may enroll.
- There is a positive test result for hepatitis B virus (HBV) or HCV indicating presence of virus (it is expected that all participants will have been serologically tested for hepatitis B in advance of this study, with HBsAG, anti-HBc IgG, and anti-HBs as per ASCO 2020 Provisional Clinical Opinion [PCO] on universal Serologic testing for hepatitis B at the onset of anticancer therapy; screening should also include an anti-HCV test prior to start of cancer treatment:
- There is a history or clinical evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the participant's participation for the full duration of the study
- Known psychiatric or substance abuse disorder that would interfere with cooperation with study requirements.
- There is a known history of regular illicit drug use and/or recent history (within the last year) of substance abuse (including alcohol).
- Participant is pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study.
- Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1
Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab).
|
Pembrolizumab is a PD-1 inhibitor.
|
|
Experimental: Arm 2
Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).
|
Pembrolizumab is a PD-1 inhibitor.
EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
|
|
Experimental: Arm 3
Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).
|
Pembrolizumab is a PD-1 inhibitor.
EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival (PFS)
Time Frame: up to 5 years
|
Progression-free survival (PFS) is defined as the time from the date of randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
|
up to 5 years
|
|
Overall survival (OS)
Time Frame: up to 5 years
|
Overall survival (OS) defined as the time from randomization to death due to any cause.
|
up to 5 years
|
|
Objective Response (OR) (Dose Optimization Only)
Time Frame: up to 5 years
|
Objective Response (OR; defined as participants who demonstrate confirmed complete response [CR] or partial response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 as assessed by the Investigator) (Dose Optimization Only).
|
up to 5 years
|
|
Adverse Events (AEs) (Dose Optimization Only)
Time Frame: up to 2.5 years
|
Adverse events (AEs), and discontinuation of study treatment due to an AE (Dose Optimization Only).
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
|
up to 2.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events (AEs) and Discontinuation of study treatment due to any AE.
Time Frame: up to 2.5 years
|
Adverse events (AEs), and discontinuation of study treatment due to any AE.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
|
up to 2.5 years
|
|
Objective Response (OR)
Time Frame: up to 5 years
|
Objective response (OR) is defined as the participants who demonstrate confirmed response (CR) or partial response (PR) according to RECIST 1.1 by BICR.
|
up to 5 years
|
|
Duration of Response (DOR).
Time Frame: up to 5 years
|
Duration of Response (DOR) is defined as the time from the first documented evidence of complete response (CR) or partial response (PR) until disease progression or death due to any cause, whichever occurs first according to RECIST 1.1 by BICR.
|
up to 5 years
|
|
Progression Free Survival (PFS)
Time Frame: up to 5 years
|
Progression Free Survival (PFS) according to RECIST 1.1 by Investigator.
|
up to 5 years
|
|
Objective Response (OR)
Time Frame: up to 5 years
|
Objective Response (OR) according to RECIST 1.1 by Investigator.
|
up to 5 years
|
|
Duration of Response (DOR)
Time Frame: up to 5 years
|
Duration of Response (DOR) according to RECIST 1.1 by Investigator
|
up to 5 years
|
|
Duration of Response (DOR) (Dose Optimization Only).
Time Frame: up to 5 years
|
Duration of Response (DOR) per RECIST 1.1 by Investigator (Dose Optimization Only).
|
up to 5 years
|
|
Progression-free survival (PFS) per RECIST 1.1 by Investigator (Dose Optimization Only).
Time Frame: up to 5 years
|
Progression-free survival (PFS) per RECIST 1.1 by Investigator (Dose Optimization Only).
|
up to 5 years
|
|
Overall survival (OS) (Dose Optimization Only)
Time Frame: up to 5 years
|
Overall survival (OS) defined as the time from randomization to death due to any cause (Dose Optimization Only).
|
up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Etah Kurland, Eikon Therapeutics
- Study Director: Muaz Sadeia, Eikon Therapeutics
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)
May 22, 2025
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2040
Study Registration Dates
First Submitted
November 18, 2024
First Submitted That Met QC Criteria
November 18, 2024
First Posted (Actual)
November 20, 2024
Study Record Updates
Last Update Posted (Actual)
May 8, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIK1001-006
- KEYNOTE-G04 (Other Identifier: Merck Sharp & Dohme LLC)
- MK-3475-G04 (Other Identifier: Merck Sharp & Dohme LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
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.
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