Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
NCT ID: NCT06697301
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
740 participants
INTERVENTIONAL
2025-05-22
2040-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab).
Pembrolizumab (KEYTRUDA® )
Pembrolizumab is a PD-1 inhibitor.
Arm 2
Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab).
EIK1001
EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
Pembrolizumab (KEYTRUDA® )
Pembrolizumab is a PD-1 inhibitor.
Arm 3
Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab).
EIK1001
EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
Pembrolizumab (KEYTRUDA® )
Pembrolizumab is a PD-1 inhibitor.
Interventions
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EIK1001
EIK1001 is a Toll-like receptor 7/8 (TLR 7/8) dual agonist.
Pembrolizumab (KEYTRUDA® )
Pembrolizumab is a PD-1 inhibitor.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eikon Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Etah Kurland
Role: STUDY_DIRECTOR
Eikon Therapeutics
Muaz Sadeia
Role: STUDY_DIRECTOR
Eikon Therapeutics
Locations
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Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
Helios Clinical Research
Los Angeles, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Bioresearch Partner
Hialeah, Florida, United States
The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
MidAmerica Cancer Care
Kansas City, Missouri, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Gabrail Cancer Center Research LLC
Canton, Ohio, United States
University of Pittsburgh Medical Center(UPMC)-Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Icon Cancer Centre Chermside
Chermside, Queensland, Australia
Southern Adelaide Local Health Network Incorporated Flinders Medical Centre
Bedford Park, South Australia, Australia
Eastern Health
Box Hill, Victoria, Australia
Universitätsklinikum Graz
Graz, Styria, Austria
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
Yvoir, Namur, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, Belgium
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, West-Vlaanderen, Belgium
Sunnybrook Research Ins<tute
Toronto, Ontario, Canada
Masaryk Memorial Cancer Institute
Brno, Brno, Czechia
University Hospital Hradec Kralove
Sokolov, Hradce Kralove, Czechia
Aarhus Universitetshospital
Aarhus, Central Jutland, Denmark
Aalborg University Hospital
Aalborg, Nord Jutland, Denmark
Oulu University Hospital
Oulu, Oulu, Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Helsinki University Hospital
Helsinki, Uusimaa, Finland
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isère, France
Hôpital La Timone
Marseille, Marseille, France
CHU Rouen
Rouen, Rouen, France
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitat Leipzig
Saxony, Leipzig, Germany
Elbe Kliniken Stade-Buxtehude
Buxtehude, Lower Saxony, Germany
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, Germany
University of Mainz Medical Center
Mainz, RLP, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
Soroka medical center
Beersheba, Be'er Sheva, Israel
Rabin Medical Center
Petah Tikva, Petach Tikva, Israel
Ella Lemelbaum Institute for Immuno-Oncology and Melanoma
Ramat Gan, Ramat Gan, Israel
Tel Aviv Medical Center
Tel Aviv, Tel Aviv, Israel
Humanitas Gavazzeni Bergamo
Bergamo, Province of Bergamo, Italy
Christchurch Public Hospital
Christchurch, Christchurch, New Zealand
Auckland City Hospital
Auckland, New Zealand, New Zealand
Nordland Hospital Trust
Bodø, Bodø, Norway
Oslo University Hospital - The Norwegian Radium Hospital
Oslo, Oslo County, Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, Gdańsk, Poland
Prezychodnia Lekarska KOMED Roman Karaszewski
Konin, Konin, Poland
Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii
Siedlce, Siedlce, Poland
Hospital da Luz Lisboa
Lisbon, Lisbon District, Portugal
Military Medical Academy- Department of Oncology
Belgrade, Belgrade, Serbia
Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, South Africa
University of Pretoria, Steve Biko Academic Hospital
Pretoria, Gauteng, South Africa
The Medical Oncology Centre of Rosebank
Saxonwold, Gauteng, South Africa
Cape Town Oncology Trials
Cape Town, Western Cape, South Africa
TASK Eden
George Central, Western Cape, South Africa
Hospital Universitari Dexeus
Barcelona, Barcelona, Spain
Vall d' Hebron Institute of Oncology
Barcelona, Barcelona, Spain
Hospital Universitario Lucus Augusti
Lugo, Galicia, Spain
Institut Català d'Oncologia Girona (ICO Girona)
Girona, Girona, Spain
University Hospital of Jerez
Jerez de La Frontera (Cádiz), Jerez de La Frontera (Cádiz), Spain
GenesisCare Madrid - Hospital San Francisco de Asís
Madrid, Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital 12 de Octubre
Usera, Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
IVO - Fundacion Instituto Valenciano de Oncologia
Valencia, Valencia, Spain
INCLIVA Instituto de Investigación Sanitaria
Valencia, Valencia, Spain
Gävle Sjukhus
Gävle, Gävleborg County, Sweden
Karolinska University Hospital
Stockholm, Södermanland County, Sweden
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland
Kantonsspital Graubünden
Chur, Chur, Switzerland
Guy's and St Thomas' NHS Foundation Trust
London, England, United Kingdom
Sarah Cannon Research Institute London
London, England, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Tiffany Wales
Role: primary
Laura Sellers
Role: primary
Sabrina Mora
Role: primary
Leslie Posadas
Role: backup
Linda Gozar
Role: primary
Ashley Miller
Role: primary
Tahimi Campa
Role: primary
Mabel Cruz
Role: backup
Taylor Stutzman
Role: primary
Logan Marney
Role: primary
Kelsey Etter
Role: primary
Carrie Smith
Role: primary
Danielle Bednarz
Role: primary
Sue Parker
Role: primary
Tabetha Gibson
Role: backup
Jesse Peet
Role: primary
Amy Goh
Role: backup
Alex Scott-Hoy
Role: primary
Alessia Belperio
Role: backup
LaiWan Reid
Role: primary
Alexandra Rodlauer-Kriegl
Role: primary
Sandrine Harzé
Role: primary
Valerie Stragier
Role: backup
Louise Favaretto
Role: primary
Beatriz Busine
Role: backup
Mathilde Parmentier
Role: primary
Geraldine Mineur
Role: backup
Loulou Dourée
Role: primary
Marjolein Dom
Role: backup
Inge Meyer
Role: primary
Angel Remmerie
Role: backup
Stephanie Lewaniak
Role: primary
Carolyn Lim
Role: backup
Hana Blahynkova
Role: primary
Klara Reznickova
Role: primary
Line M Sparvath
Role: primary
Lone Dall
Role: backup
Lotte Andersen
Role: primary
Celine Nielsen
Role: backup
Raija Mikkonen
Role: primary
Marjo Koivisto
Role: primary
Jacoba Peterson-Hirvonen
Role: primary
Caroline Marchi
Role: primary
Stéphane Mouret
Role: primary
Kahina DJENAD-ICHALLAL
Role: primary
Elodie Geant
Role: primary
Katharina Thuene
Role: primary
Marianne Kraus
Role: primary
Silke Weidauer-Zuniga
Role: primary
Christin Pavlović
Role: backup
Lioba Starp
Role: primary
Uta Haisch
Role: backup
Helge Wuttig
Role: primary
Claudia Bauer
Role: primary
Susanne Wagner
Role: backup
Frauke Westermann
Role: primary
Corinna Schirmann
Role: backup
Jenny Koop
Role: primary
Beate Gehrt
Role: backup
Margarita Boltian
Role: primary
Noa Konvalina
Role: primary
Osnat Mazuz
Role: primary
Hagit Damchiner-Pearl
Role: primary
Paola Maggioni
Role: primary
Katharine Moore
Role: primary
Jessica Lalanne
Role: primary
Ruta Padalkar
Role: backup
Petter Øien
Role: primary
Kirsten Hagene
Role: primary
Elżbieta Kurzawa
Role: primary
Dorota Pospieszynska
Role: primary
Tomasz Milewski
Role: primary
Catarina Aleixo
Role: primary
Filipa Nunes
Role: backup
Vesna Nesic
Role: primary
Anna Szőke
Role: primary
Venolia Mohlabine
Role: primary
Teresa Smit
Role: primary
Theo Niemand
Role: primary
Pieter Laubscher
Role: backup
Pieter Lennox
Role: primary
Susanna Loock
Role: backup
Carlos Esparre
Role: primary
Marta Juan
Role: backup
Alba Barrio
Role: primary
Núria Llansana
Role: backup
Raquel Romero
Role: primary
Begoña M Castillo
Role: primary
Bruna Castilhos
Role: backup
Mari Carmen Leon
Role: primary
Araceli Rodriguez
Role: primary
Isabel Cañete
Role: primary
Maria Jesus Perez Lorenzo
Role: primary
Desireeh Fernandez
Role: primary
Raquel Bayona
Role: primary
Belen Vazquez
Role: backup
Paqui Fernandez
Role: primary
Paloma Campos
Role: backup
Ulrika Åsenlund
Role: primary
Johanna Lofberg Betts
Role: primary
Lucien Morel
Role: primary
Julia Püschel
Role: backup
Gabriela Manetsch
Role: primary
Rumana Parvin
Role: primary
Taiwo Oguntoyinbo
Role: backup
Sebastian Agredo
Role: primary
Other Identifiers
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KEYNOTE-G04
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-G04
Identifier Type: OTHER
Identifier Source: secondary_id
EIK1001-006
Identifier Type: -
Identifier Source: org_study_id