Advanced MelanomaPhase 2/3NCT06697301
Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
A Phase 2/3 study testing EIK1001 and Pembrolizumab (KEYTRUDA® ) in people with Advanced Melanoma, run by Eikon Therapeutics at 127 sites in 24 countries.
Trial summary
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- EIK1001 and Pembrolizumab (KEYTRUDA® )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 127 sitesin 24 countries
- Study dates
- 22 May 2025to Dec 2040
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
127 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
127 sites in 24 countries
Spain19 sites, 19 recruiting
- Recruiting
H. Germans Trias I Pujol (ICO-Badalona)
Badalona, Badalona, 08916
Laura Millares Costas, +34 677254583, lmillares@iconcologia.net
José Manzano
- Recruiting
Hospital Universitari Dexeus
Barcelona, Barcelona, 08028
Carlos Esparre, +34 93 54 60 143, cesparre@oncorosell.com
Marta Juan, +34 93 54 60 143, mjuan@oncorosell.com
- Recruiting
Vall d' Hebron Institute of Oncology
Barcelona, Barcelona, 08035
Alba Barrio, (+34) 93 254 34 50 ext. 8827, bbruno@vhio.net
Núria Llansana, (+34) 93 254 3450 ext. 5063, nfarras@vhio.net
- Recruiting
Hospital Clinic Barcelona
Barcelona, Spain, 8036
Nadina Fradera, (+34) 687727943 ext. 383541, fradera@recerca.clinic.cat
Julio Vidal, +39 663 467 747 ext. 381716, juvidal@recerca.clinic.cat
- Recruiting
San Pedro de Alcántara Hospital
Cáceres, Cáceres, 10003
Julia Cruces González, +34 927256406, julia.crucesgonzalez@externos.salud-juntaex.es
Pablo Ayala
- Recruiting
University Hospital of Jerez
Cadiz, 11407
Mari Carmen Leon, +34 956 03 22 44, carmen.oncojerez@gmail.com
Regina Garcia Galindo
- Recruiting
Institut Català d'Oncologia Girona (ICO Girona)
Girona, Girona, 17007
Begoña M Castillo, +34 972 22 58 28, bmartin@iconcologia.net
Bruna Castilhos, nmartin@iconcologia.net
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
Raquel Romero, +34 982 296459, raquel.romero.van.der.schoot@sergas.es
Begona Campos Balea
- Recruiting
GenesisCare Madrid - Hospital San Francisco de Asís
Madrid, Madrid, 28002
Araceli Rodriguez, +34 916219256, arodriguez.oncologytrials@gmail.com
José Angel Garcia Cuesta
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Isabel Cañete, 915868161, icg.hgugm@gmail.com
IVAN MARQUEZ
- Recruiting
HM CIOCC
Madrid, Madrid, 28050
Paloma Vargas Durán, +34 91 756 78 00 ext. +4814, pvargas@hmhospitales.com
Juan Rodriguez Moreno
- Recruiting
Hospital Regional Universitario
Málaga, Malaga, 29011
Irene Rojas García, +34 608093004, ensayosch@yahoo.es
Miguel Angel Berciano
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
Desireeh Fernandez, +34 951032508, desireeh.fernandez@ibima.eu
Manuel Zalabardo
- Recruiting
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
Paula Ruiz, +34 968 36 91 51, dm.oncoarrixaca2@gmail.com
Pablo Fuentes
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Laura Pérez, +34 942 20 33 51, laura.revuelta@idival.org
Marta García
- Recruiting
Hospital Clínico de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Veronica Rivas, +34 981956332 ext. 256332, veronica.rivas.limeres@gmail.com
Teresa Curiel
- Recruiting
Hospital 12 de Octubre
Usera, Madrid, 28031
Maria Jesus Perez Lorenzo, +34913908547, startup.oncology.imas12@h12o.es
Guillermo De Velasco
- Recruiting
IVO - Fundacion Instituto Valenciano de Oncologia
Valencia, Valencia, 46009
Raquel Bayona, 671429340, datamanager33@fincivo.org
Belen Vazquez, 663224875, coordinacion@fincivo.org
- Recruiting
INCLIVA Instituto de Investigación Sanitaria
Valencia, Valencia, 46010
Paqui Fernandez, +34) 96 197 35 00 ext. 436696, ffernandez@incliva.es
Paloma Campos, +34 682 43 47 08, pcampos@incliva.es
Germany16 sites, 16 recruiting
- Recruiting
Charite Department of Dermatology, Venereology and Allergology
Berlin, State of Berlin, 10115
Nurcan Uzun, +49 30 450 518 448, nurcan.uzun@charite.de
Thomas Eigentler
- Recruiting
Elbe Kliniken Stade-Buxtehude
Buxtehude, Lower Saxony, 21614
Lioba Starp, +4941617036212, Lioba.starp@elebekliniken.de
Uta Haisch, uta.haisch@elbekliniken.de
- Recruiting
University Hospital Carl Gustav Carus Dresden
Dresden, 01307
Daniela Ruhnau, +49 351 458 19782, daniela.ruhnau@ukdd.de
Friedegund Meier
- Recruiting
Helios Klinikum Erfurt
Erfurt, D-99089
Cornelia Greifzu, +49 361 781-5035, cornelia.greifzu@helios-gesundheit.de
Johann Oellers, +49 361 781-5141, johann.oellers@helios-gesundheit.de
- Recruiting
University Hospital Erlangen
Erlangen, Erlangen, 91054
Ruth Simanek, +49 9131 8545861, ruth.simanek@uk-erlangen.de
Carola Berking
- Recruiting
SRH Wald-Klinikum Gera GmbH
Gera, 07548
Kristin Zoeger, +49 365 828 7758, kristin.zoeger@srh.de
Mandy Michaelis, +49 365 828 7758, mandy.michaelis@srh.de
- Recruiting
Universität Leipzig
Haus, Leipzig, 04103
Silke Weidauer-Zuniga, +493419718750, silke.weidauer-zuniga@medizin.uni-leipzig.de
Christin Pavlović, +49 341 97 18380, christin.pavlovic@medizin.uni-leipzig.de
- Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, 24105
Frauke Westermann, +49 431 500 21133, fwestermann@dermatology.uni-kiel.de
Corinna Schirmann, +49 431 500 21136, cschirmann@dermatology.uni-kiel.de
- Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, 23538
Jenny Koop, +49 451 500 41570, jenny.koop@uksh.de
Beate Gehrt, +49 451 500 41570, beate.gehrt@uksh.de
- Recruiting
University of Mainz Medical Center
Mainz, RLP, 55131
Claudia Bauer, +496131175147, claudia.bauer@unimedizin-mainz.de
Susanne Wagner, Susanne.Wagner2@unimedizin-mainz.de
- Recruiting
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, 68167
Katharina Thuene, +49 621 383-3993, katharina.thuene@dkfz-heidelberg.de
Jochen Utikal
- Recruiting
Universitätsklinik Hamburg Eppendorf
Martinsried, Free and Hanseatic City of Hamburg, 20246
Christin Seeger, +49 15222800599, c.seeger@uke.de
Christoffer Gebhardt
- Recruiting
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, 32429
Helge Wuttig, +49-(0)571-790-54528, helge.wuttig@muehlenkreiskliniken.de
Ralf Gutzmer
- Recruiting
Fachklinik Hornheide
Münster, 48157
Konigkamp Romina, +49 251 32 87 505, romina.koenigkamp@fachklinik-hornheide.de
Carmen Loquai
- Recruiting
Universitaetsklinikum Tuebingen (UKT)
Tübingen, Baden-Wurttemberg, 72076
Melanie Peter, +49 7071 29 84555, melanie.peter@med.uni-tuebingen.de
Andreas Meiwes
- Recruiting
Klinik für Dermatologie, Venerologie und Allergologie
Würzburg, Bavaria, 97080
Jana Riederer, +49 931-201-26762, riederer_j@ukw.de
Sandra Hupfloher, +49 931 201 26762, hasseli_s@ukw.de
United States14 sites, 14 recruiting
- Recruiting
The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Taylor Stutzman, 301-571-2016, taylor.stutzman@aoncology.com
Victor Priego
- Recruiting
Gabrail Cancer Center Research LLC
Canton, Ohio, 44718
Carrie Smith, 330-417-8231, csmith@gabrailcancercenter.com
Nashat Gabrail
- Recruiting
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Tiffany Wales, 480-256-1372 ext. 27104, TIffany.Walas@ironwoodcrc.com
Amikar Sehdev, MD
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Ashley Miller, 719-365-5062, ashley.miller5@uchealth.org
Stacey ParkerBrueggemann, MD
- Recruiting
Bioresearch Partner
Hialeah, Florida, 33013
Tahimi Campa, 833-489-4968, tdelacampa@bioresearchpartner.com
Mabel Cruz, 833-489-4968, mcruz@bioresearchpartner.com
- Recruiting
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913
Laura Sellers, 5016247700 ext. 63839, Laura.Sellers@aoncology.com
Robert Muldoon
- Recruiting
MidAmerica Cancer Care
Kansas City, Missouri, 64132
Logan Marney, 833-886-1725, Logan.Marney@aoncology.com
Jaswinder Singh
- Recruiting
Helios Clinical Research
Los Angeles, California, 90015
Sabrina Mora, 562-735-3226, Sabrinamora@theoncologyinstitute.com
Leslie Posadas, leslieposadas@theoncologyinstitute.com
- Recruiting
Christiana Care
Newark, Delaware, 19713
Jennifer Knotts, 302- 623-4889, JKnotts@christianacare.org
Julie Falango, Julie.falango@christianacare.org
- Recruiting
University of Pittsburgh Medical Center(UPMC)-Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Danielle Bednarz, 412 623-1191, bednarzdl@upmc.edu
Diwakar Davar, MD
- Recruiting
Providence Medical Foundation
Santa Rosa, California, 95403
Linda Gozar, +1 714-992-3000 ext. 4332, Linda.Gozar@stjoe.org
David Park
- Recruiting
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63108
Kelsey Etter, 314-273-0656, etter@wustl.edu
George Ansstas
- Recruiting
Patientcare Clinical Research
Sugar Land, Texas, 77479
Muhammad Muzammil, 1 (732) 358-3048, muzammil@patientcareclinicalresearch.com
Amir Rasheed
- Recruiting
Florida Clinical Trials Group - Tamarac
Tamarac, Florida, 33321
Maria Abreu, (772) 297-3057, abreum@floridactg.com
Mairan Rivera, 772-297-3057, riveram@floridactg.com
Italy12 sites, 12 recruiting
- Recruiting
Azienda Ospedaliera Universitaria SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
Alessia Garau, +39 0131 206852, alessia.garau@aou.al.it
Lorenzo Lobina, +39 0131 206852, lorenzo.lobina@aou.al.it
- Recruiting
Clinica Oncologia Delle Marche
Ancona, The Marches, 60126
Alessandra Lucarelli, +39 071 5965093, alessandra.lucarelli@ospedaliriuniti.marche.it
Rossana Berardi
- Recruiting
Humanitas Gavazzeni Bergamo
Bergamo, Province of Bergamo, 24125
Paola Maggioni, +39 0354204760, paola.maggioni@gavazzeni.it
Laura Pala
- Recruiting
IRCCS Ospedale Policlinico San Marino
Genoa, Liguria, 16132
Cristiana Fava, +39 010 5558916, cristiana.fava@aomliguria.it
Alessia Graziana Bosio, +39 010 5558911, alessiagraziana.bosio@aomliguria.it
- Recruiting
Ospedale San Vincenzo Taormina
Messina, Italy, 98039
Simone Cardone, +39 3456108735, simonacardone@hotmail.it
Carmela Pania, +39 3496619293, carmela.pania@asp.messina.it
- Recruiting
Fondazione IRCSS - Istituto Nazionale dei Tumori
Milan, Italy, 20133
Ilaria Bisogno, +390223902894, ilaria.bisogno@istitutotumori.mi.it
Maria Montesanto, +39 0223903839, maria.montesanto@istitutotumori.mi.it
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Nicola Fogale, +39 02 2643 9024, fogale.nicola@hsr.it
Vincenzo Russo
- Recruiting
AOU Policlinico di Modena
Modena, Italy, 41125
Cristiana Rossetti, +39 0594222061, rossetti.cristiana@aou.mo.it
Michela Palmieri, +39 0594222062, mpalmier@unimore.it
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Davide Campagnolo, +39 0498215981, davide.campagnolo@iov.veneto.it
Giovanna Chiara Surace, +39 0498215982, giovannachiara.surace@iov.veneto.it
- Recruiting
Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Foggia, 71013
Carmela D'Arienzo, +39 0882410716, c.darienzo@operapadrepio.it
Cinzia Chiarazzo, +39 0882410716, cinzia.chiarazzo@gmail.com
- Recruiting
UOC Immunoterapia Oncologica
Siena, Tuscany, 53100
Elisa Ibba, +39 577586056, elisa.ibba@ao-siena.toscana.it
Anna Maria Di Giacomo
- Recruiting
Azienda Provinciale per I Servizi Sanitari
Trento, Italy, 38123
Renza Triolo, +39 0461903178, renza.triolo@asuit.tn.it
Roberta Biondi, +39 0461904747, roberta.biondi@asuit.tn.it
France10 sites, 10 recruiting
- Recruiting
Hospital Saint Andre
Bordeaux, 33075
Gaelle Domingo, +33557820655, gaelle.domingo@chu-bordeaux.fr
Caroline Dutriaux
- Recruiting
A Paré
Boulogne, Boulogne, 92104
Veronique Clerisse, +33618458154, veronique.clerisse@aphp.fr
Marine Masson, +33 1 49 09 52 75, marinesuzanne.masson@aphp.fr
- Recruiting
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isère, 38700
Stéphane Mouret, +33476767081, smouret1@chu-grenoble.fr
Julie Charles
- Recruiting
CHU Lille
Lille, Lille Cedex, 59037
Léa Malvoisin, +33320446415, lea.malvoisin@chu-lille.fr
Sara Aliouane, +33320443597, sara.aliouane@chu-lille.fr
- Recruiting
Hôpital La Timone
Marseille, Marseille, 13385
Kahina DJENAD-ICHALLAL, +33 0491 38 88 03, Kahina.DJENAD@ap-hm.fr
Caroline Gaudy
- Recruiting
Centre Hospitalier Universitaire (CHU) Nice
Nice, PACA, 06200
Emmanuelle Pradelli, +33492036667, pradelli.e@chu-nice.fr
Henri Montaudie
- Recruiting
Hôpital Bichat AP-HP Université Paris Cité
Paris, Paris, 75018
Sabrina Djerroud, +33 1 40 25 64 63, sabrina.djerroud@aphp.fr
Florence Brunet-Possenti
- Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495
Caroline Marchi, +33 04 78 86 33 35, caroline.marchi@chu-lyon.fr
Stéphane Dalle
- Recruiting
CHU Rouen
Rouen, Rouen, 76031
Elodie Geant, (33) 02 32 88 66 99 ext. 6 66 99, elodie.geant@chu-rouen.fr
Anne Benedicte Duval Modeste
- Recruiting
ICO Saint Herblain
Saint-Herblain, Pays de la Loire Region, 44800
Caoline Perrault, +33 2 40 67 99 1, caroline.perrault@ico.unicancer.fr
Elodie Planchais, +33 2 40 67 99 00, elodie.planchais@ico.unicancer.fr
South Africa7 sites, 7 recruiting
- Recruiting
Cape Town Oncology Trials
Cape Town, Western Cape, 7570
Theo Niemand, +27 (0)71 129 1765, theo.niemand@ctot.co.za
Pieter Laubscher, +27 (0)82 748 3608, pieter.laubscher@ctot.co.za
- Recruiting
TASK Eden
George, Western Cape, 6529
Pieter Lennox, +27 (0) 82 853 4991, pieter@task.org.za
Susanna Loock, +27 72 423 4763, sumaria.l@task.org.za
- Recruiting
Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, 6045
Anna Szőke, +36 209529 303, aszoke@ledgerrun.com
John Crockett
- Recruiting
University of Pretoria, Steve Biko Academic Hospital
Pretoria, Gauteng, 0002
Venolia Mohlabine, +27 12 354 2022, Venolia.Mohlabine@up.ac.za
Richard Khanyile
- Recruiting
Curo Oncology
Pretoria, Pretoria, 0084
Lenore Dirker, +27 12 335 6771, research@curo-oncology.co.za
Rouchelle Marais-Nieman
- Recruiting
Abraham Oncology
Richards Bay, KwaZulu-Natal, 3900
Debbie Jacobs, +27 347800247, debbie@drabraham.co.za
Smitha Abraham
- Recruiting
The Medical Oncology Centre of Rosebank
Saxonwold, Gauteng, 2196
Teresa Smit, 0027828805944, data@rapoport.co.za
Bernardo Rapoport
Belgium6 sites, 6 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200
Louise Favaretto, +32 2 764 35 13, louise.favaretto@saintluc.uclouvain.be
Beatriz Busine, +32 2 764 13 31, guichetcommercial@saintluc.uclouvain.be
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, 2650
Sandrine Harzé, +3234368354, sandrine.harze@uza.be
Valerie Stragier, +32 3 436 8091, valerie.stragier@uza.be
- Recruiting
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, West-Vlaanderen, 8500
Inge Meyer, +32 56 63 39 40, inge.meyer@azgroeninge.be
Angel Remmerie, +32 56 63 39 75, cta.oncologie@azgroeninge.be
- Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000
Loulou Dourée, +32 16 34 39 44, loulou.douree@uzleuven.be
Marjolein Dom, +32 16 34 59 91, marjolein.dom@uzleuven.be
- Recruiting
Vitaz Primary Location
Sint-Niklaas, 9100
Luna Van Hoyweghen, +32 3760 7627, luna.vanhoyweghen@vitaz.be
Ines Deleu
- Recruiting
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
Yvoir, Namur, B-5530
Mathilde Parmentier, +32 0 81 42 38 57, mathilde.parmentier@chuuclnamur.uclouvain.be
Geraldine Mineur, +32 81 42 38 55, geraldine.mineur@uclouvain.be
Australia5 sites, 5 recruiting
- Recruiting
Southern Adelaide Local Health Network Incorporated Flinders Medical Centre
Bedford Park, South Australia, 5042
Alex Scott-Hoy, 08 8204 4485, alex.scott-hoy@sa.gov.au
Alessia Belperio, (08) 8204 5054, alessia.belperio@sa.gov.au
- Recruiting
Eastern Health
Box Hill, Victoria, 3128
LaiWan Reid, +61 474 871 676, laiwan.reid@monash.edu
Phillip Parente
- Recruiting
Icon Cancer Centre Chermside
Chermside, Queensland, 4032
Jesse Peet, +07 3737 4539, Jesse.Peet@icon.team
Amy Goh, +0438597944, amy.goh@icon.team
- Recruiting
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
Albert Goikhman, +61 422510299, ag@paso.com.au
Vinod Ganju
- Recruiting
Cancer Care Wollongong
Wollongong, New South Wales, 2500
Sue Parker, +61 242439708, Sparker@cancercarewollongong.com.au
Tabetha Gibson, TGibson@cancercarewollongong.com.au
Poland5 sites, 5 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, Gdańsk, 80-952
Elżbieta Kurzawa, +48517331593, ekurzawa@uck.gda.pl
Kamil Drucis
- Recruiting
Maria Sklodowska-Curie Na;onal Research Ins;tute of Oncology, Gliwice Branch
Gliwice, Silesian Voivodeship, 44-102
Dorota Trzcińska, +48 32-278-8237, Dorota.trzcinska@gliwice.nio.gov.pl
Anna Hebda, +48 32-278-8237, anna.hebda@gliwice.nio.gov.pl
- Recruiting
Prezychodnia Lekarska KOMED Roman Karaszewski
Konin, Konin, 62-500
Dorota Pospieszynska, +48632406136, d.pospieszynska45@gmail.com
Bogusława Karaszewska
- Recruiting
Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii
Siedlce, Siedlce, 08-110
Tomasz Milewski, +48600173523, tmilewski@szpital.siedlce.pl
Lubomir Bodnar
- Recruiting
Maria Sklodowska-Curie National Cancer Research Institute
Warsaw, Warsaw, 02-781
Anna Gluszcz, +48 22 546 26 03, anna.gluszcz@nio.gov.pl
Anna Czarnecka
Israel4 sites, 4 recruiting
- Recruiting
Soroka medical center
Beersheba, Be'er Sheva, 8410101
Margarita Boltian, 972 8-6403375, margaritabol@clalit.org.il
Alexander Yakobson
- Recruiting
Rabin Medical Center
Petah Tikva, Petach Tikva, 4941492
Noa Konvalina, +97239378077, noakon@clalit.org.il
Nethanel Asher
- Recruiting
Ella Lemelbaum Institute for Immuno-Oncology and Melanoma
Ramat Gan, Ramat Gan, 5262100
Osnat Mazuz, +972 35307916, osnat.mazuz@sheba.health.gov.il
Ronnie Shapira-Frommer
- Recruiting
Tel Aviv Medical Center
Tel Aviv, Tel Aviv, 6423906
Hagit Damchiner-Pearl, 972-52-7360519, hagitdp@tlvmc.gov.il
Mor Miodovnik
United Kingdom4 sites, 4 recruiting
- Recruiting
Belfast City Hospital, Belfast Health and Social Care Trust
Belfast, Belfast, BT9 7AB
Eimear Nicholl, +4428 9504 7412 ext. 47412, Eimear.nicholl@belfasttrust.hsc
Bode Oladipo
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, England, SE1 9RT
Rumana Parvin, 020 7188 7188 ext. 57422, rumana.parvin@gstt.nhs.uk
Taiwo Oguntoyinbo, 020 7188 2019 ext. 82019/57422, taiwo.guntoyinbo@gstt.nhs.uk
- Recruiting
Sarah Cannon Research Institute London
London, England, W1G6AD
Sebastian Agredo, +44 203 219 5211, Sebastian.Agredo@hcahealthcare.co.uk
Anja Williams
- Recruiting
University Hospital Southampton
Southampton, Hampshire, SO32 2DA
Connie Temple-Brown, +44 2380777222, constance.temple-brown@uhs.nhs.uk
Matthew Wheater
Finland3 sites, 3 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, Uusimaa, 00029
Jacoba Peterson-Hirvonen, +358-50-372 9043, jacoba.peterson-hirvonen@hus.fi
Micaela Hernberg
- Recruiting
Oulu University Hospital
Oulu, Oulu, 90230
Raija Mikkonen, +358405057872, raija.mikkonen@pohde.fi
Sanna Livanainen
- Recruiting
Tampere University Hospital
Tampere, Pirkanmaa, 33521
Marjo Koivisto, +358444728004, marjo.koivisto@pirha.fi
Tanja Skyttä
Norway3 sites, 3 recruiting
- Recruiting
Nordland Hospital Trust
Bodø, Bodø, N-8005
Petter Øien, +47 75599133, petter.oien@nlsh.no
Bard Mannsaker
- Recruiting
Drammen Hospital
Drammen, Oslofjord, 3004
Siri Bråthen, +47 32862464, siri.brathen@vestreviken.no
Alina Carmen Porojnicu
- Recruiting
Oslo University Hospital - The Norwegian Radium Hospital
Oslo, Oslo, 0310
Kirsten Hagene, +47 99293273, kihage@ous-hf.no
Marta Nyakas
Czechia2 sites, 2 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, Brno, 65653
Hana Blahynkova, +420 543 136 233, hana.blahynkova@mou.cz
Radek Lakomy
- Recruiting
University Hospital Hradec Kralove
Sokolov, Hradce Kralove, 50009
Klara Reznickova, +420495832849, klara.reznickova@fnhk.cz
Jindrich Kopecky
Denmark2 sites
- Suspended
Aalborg University Hospital
Aalborg, Nord Jutland, 9000
- Suspended
Aarhus Universitetshospital
Aarhus, Central Jutland, 8200
Hungary2 sites, 2 recruiting
- Recruiting
National Institute of Oncology
Budapest, Budapest, 1122
Barbara Varga, +36204553579, varga.barbara@oncol.hu
Timea Balatoni
- Recruiting
University of Pécs
Pécs, 7632
Andrea Morvane Kiss, +3672-536-882, morvane.andrea@pte.hu
Zsuzsanna Lengyel
New Zealand2 sites, 2 recruiting
- Recruiting
Auckland City Hospital
Auckland, New Zealand, 1023
Jessica Lalanne, +64 9 3074949 ext. 21837, jlalanne@adhb.govt.nz
Ruta Padalkar, +64 9 3074949, RutaP@adhb.govt.nz
- Recruiting
Christchurch Public Hospital
Christchurch, Christchurch, 8011
Katharine Moore, +64 2740 66867, Katharine.Moore@cdhb.health.nz
David Gibbs
Portugal2 sites, 2 recruiting
- Recruiting
IPO Lisboa
Lisbon, Lisbon District, 1099-023
Bruna Pavia, +35 933464102, bpavia@ipolisboa.min-saude.pt
Patricia Pereira
- Recruiting
Hospital da Luz Lisboa
Lisbon, Lisbon District, 1500-650
Catarina Aleixo, +351.217.104.544 ext. 44659, caleixo@hospitaldaluz.pt
Filipa Nunes, +351 217 104 400 ext. 44660, filipa.nunes@luzsaude.pt
South Korea2 sites, 2 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Soon Im Lee, +82 53 200 3177, silee@knuh-ext.kr
Soo Jung Lee
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jiyoo Jung, (+82) 01046433169, jiyoo8843@snu.ac.kr
Miso Kim
Sweden2 sites, 2 recruiting
- Recruiting
Gävle Sjukhus
Gävle, Gävleborg County, 801 88
Ulrika Åsenlund, +46 722077689, ulrika.asenlund@regiongavleborg.se
Ilke Cikman
- Recruiting
Karolinska University Hospital
Stockholm, Södermanland County, 17176
Johanna Lofberg Betts, +46 8 12373388, johanna.lofberg-betts@regionstockholm.se
Hannah Eriksson
Switzerland2 sites, 2 recruiting
- Recruiting
Kantonsspital Graubünden
Chur, Chur, 7000
Gabriela Manetsch, +41812566860, gabriela.manetsch@ksgr.ch
Roger von Moos
- Recruiting
Universitätsspital Zürich
Zurich, Canton of Zurich, 8091
Lucien Morel, +41 44 255 18 59, lucien.morel@usz.ch
Julia Püschel, +41 44 255 9485, julia.pueschel@usz.ch
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinikum Graz
Graz, Styria, 8036
Alexandra Rodlauer-Kriegl, +43 316385 80169, alexandra.rodlauer-kriegl@medunigraz.at
Ingrid Wolf
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Research Ins<tute
Toronto, Ontario, M4N 3M5
Stephanie Lewaniak, +1 416-480-5000 ext. 689957, stephanie.lewaniak@sunnybrook.ca
Carolyn Lim, +1 416-480-5000 ext. 67219, carolyn.lim@sunnybrook.ca
Serbia1 site, 1 recruiting
- Recruiting
Military Medical Academy- Department of Oncology
Belgrade, Belgrade, 11000
Vesna Nesic, +381641452888, vesnanesic8@gmail.com
Lidija Kandolf
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Melanoma
- Being tested
- EIK1001, Pembrolizumab (KEYTRUDA® )
- Keywords
- Metastatic, Advanced
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIK1001Drug
EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
Pembrolizumab (KEYTRUDA® )Drug
Pembrolizumab is a PD-1 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab). Receives: Drug: Pembrolizumab (KEYTRUDA® ) |
| Arm 2 | Experimental | Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab). Receives: Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA® ) |
| Arm 3 | Experimental | Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab). Receives: Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA® ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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.
Measured: up to 5 years
Overall survival (OS)
Overall survival (OS) defined as the time from randomization to death due to any cause.
Measured: up to 5 years
Objective Response (OR) (Dose Optimization Only)
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).
Measured: up to 5 years
Adverse Events (AEs) (Dose Optimization Only)
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.
Measured: up to 2.5 years
Secondary outcomes (9)
Adverse Events (AEs) and Discontinuation of study treatment due to any AE.
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.
Measured: up to 2.5 years
Objective Response (OR)
Objective response (OR) is defined as the participants who demonstrate confirmed response (CR) or partial response (PR) according to RECIST 1.1 by BICR.
Measured: up to 5 years
Duration of Response (DOR).
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.
Measured: up to 5 years
Progression Free Survival (PFS)
Progression Free Survival (PFS) according to RECIST 1.1 by Investigator.
Measured: up to 5 years
Objective Response (OR)
Objective Response (OR) according to RECIST 1.1 by Investigator.
Measured: up to 5 years
Duration of Response (DOR)
Duration of Response (DOR) according to RECIST 1.1 by Investigator
Measured: up to 5 years
Duration of Response (DOR) (Dose Optimization Only).
Duration of Response (DOR) per RECIST 1.1 by Investigator (Dose Optimization Only).
Measured: up to 5 years
Progression-free survival (PFS) per RECIST 1.1 by Investigator (Dose Optimization Only).
Progression-free survival (PFS) per RECIST 1.1 by Investigator (Dose Optimization Only).
Measured: up to 5 years
Overall survival (OS) (Dose Optimization Only)
Overall survival (OS) defined as the time from randomization to death due to any cause (Dose Optimization Only).
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start22 May 2025
- Primary completionDec 2035 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eikon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Etah Kurland, Study director, Eikon TherapeuticsMuaz Sadeia, Study director, Eikon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697301
- Sponsor's protocol ID
- EIK1001-006
- Other IDs
- KEYNOTE-G04, MK-3475-G04
- Status last verified
- May 2026
- First submitted
- 18 Nov 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No