Actively Recruiting
Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
Led by Eikon Therapeutics · Updated on 2026-05-08
740
Participants Needed
107
Research Sites
810 weeks
Total Duration
On this page
Sponsors
E
Eikon Therapeutics
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.
CONDITIONS
Official Title
Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of informed consent.
- Have a life expectancy of at least 3 months.
- Have confirmed Stage 3 (unresectable) or Stage 4 metastatic melanoma.
- Be eligible for standard therapy with pembrolizumab.
- Have at least one measurable lesion by CT or MRI at baseline.
- Have known BRAF V600 mutation status or agree to testing.
- Completed prior radiotherapy at least 2 weeks before study treatment.
- Have an ECOG Performance Status of 0 to 1.
- Have adequate organ and marrow function based on recent lab tests.
- Women of childbearing potential must have a negative pregnancy test within 72 hours before first dose.
- Willing to use effective contraception or abstain from heterosexual activity during the study (applies to women of childbearing potential).
- Male participants with partners who are women of childbearing potential must use approved contraception.
- Able and willing to provide written informed consent.
You will not qualify if you...
- Melanoma of ocular origin.
- Currently enrolled in or recently received investigational treatment with EIK1001 or placebo within 4 weeks or 5 half-lives.
- Received prior systemic therapy for advanced melanoma (except permitted prior adjuvant or neoadjuvant therapies with conditions).
- Experienced Grade 3 or higher adverse events from prior anti-PD-1 therapy.
- Had major surgery less than 3 weeks before first dose.
- Received live-virus vaccination within 30 days before first dose.
- History of prior malignancy unless disease-free for 5 years after curative therapy.
- Known active brain metastases or carcinomatous meningitis.
- Mean resting QTcF over 470 ms on ECG.
- Active autoimmune disease requiring systemic treatment in past 2 years, except certain conditions.
- Chronic or recent systemic steroid or immunosuppressive treatment.
- History or current pneumonitis or interstitial lung disease requiring steroids.
- Active infections requiring treatment.
- Uncontrolled HIV infection.
- Positive hepatitis B or C virus test indicating active infection.
- Conditions or treatments that could interfere with study participation.
- Psychiatric or substance abuse disorders affecting cooperation.
- History of regular illicit drug use or recent substance abuse including alcohol.
- Pregnant, breastfeeding, or planning conception during the study.
- Taking strong CYP3A4 or CYP1A2 inhibitors or inducers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 107 locations
1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
3
Helios Clinical Research
Los Angeles, California, United States, 90015
Actively Recruiting
4
Providence Medical Foundation
Santa Rosa, California, United States, 95403
Actively Recruiting
5
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
6
Bioresearch Partner
Hialeah, Florida, United States, 33013
Actively Recruiting
7
The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Actively Recruiting
8
MidAmerica Cancer Care
Kansas City, Missouri, United States, 64132
Actively Recruiting
9
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63108
Actively Recruiting
10
Gabrail Cancer Center Research LLC
Canton, Ohio, United States, 44718
Actively Recruiting
11
University of Pittsburgh Medical Center(UPMC)-Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
Cancer Care Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
13
Icon Cancer Centre Chermside
Chermside, Queensland, Australia, 4032
Actively Recruiting
14
Southern Adelaide Local Health Network Incorporated Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
15
Eastern Health
Box Hill, Victoria, Australia, 3128
Actively Recruiting
16
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Actively Recruiting
17
Universitätsklinikum Graz
Graz, Styria, Austria, 8036
Actively Recruiting
18
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
19
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
20
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne
Yvoir, Namur, Belgium, B-5530
Actively Recruiting
21
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
22
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, West-Vlaanderen, Belgium, 8500
Actively Recruiting
23
Vitaz Primary Location
Sint-Niklaas, Belgium, 9100
Actively Recruiting
24
Sunnybrook Research Ins<tute
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
25
Masaryk Memorial Cancer Institute
Brno, Brno, Czechia, 65653
Actively Recruiting
26
University Hospital Hradec Kralove
Sokolov, Hradce Kralove, Czechia, 50009
Actively Recruiting
27
Aarhus Universitetshospital
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
28
Aalborg University Hospital
Aalborg, Nord Jutland, Denmark, 9000
Actively Recruiting
29
Oulu University Hospital
Oulu, Oulu, Finland, 90230
Actively Recruiting
30
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33521
Actively Recruiting
31
Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00029
Actively Recruiting
32
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
Actively Recruiting
33
A Paré
Boulogne, Boulogne, France, 92104
Actively Recruiting
34
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isère, France, 38700
Actively Recruiting
35
CHU Lille
Polonovski, Lille Cedex, France, 59037
Actively Recruiting
36
Hôpital La Timone
Marseille, Marseille, France, 13385
Actively Recruiting
37
Centre Hospitalier Universitaire (CHU) Nice
Nice, PACA, France, 06200
Actively Recruiting
38
Hôpital Bichat AP-HP Université Paris Cité
Paris, Paris, France, 75018
Actively Recruiting
39
ICO Saint Herblain
Saint-Herblain, Pays de la Loire Region, France, 44800
Actively Recruiting
40
CHU Rouen
Rouen, Rouen, France, 76031
Actively Recruiting
41
Hospital Saint Andre
Bordeaux, France, 33075
Actively Recruiting
42
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
43
Universitaetsklinikum Tuebingen (UKT)
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
44
Klinik für Dermatologie, Venerologie und Allergologie
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
45
Universitätsklinik Hamburg Eppendorf
Martinsried, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
46
Universitat Leipzig
Saxony, Leipzig, Germany, 04103
Actively Recruiting
47
Elbe Kliniken Stade-Buxtehude
Buxtehude, Lower Saxony, Germany, 21614
Actively Recruiting
48
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, Germany, 32429
Actively Recruiting
49
University of Mainz Medical Center
Mainz, RLP, Germany, 55131
Actively Recruiting
50
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
51
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
52
Charite Department of Dermatology, Venereology and Allergology
Berlin, State of Berlin, Germany, 10115
Actively Recruiting
53
Fachklinik Hornheide
Münster, Germany, 48157
Actively Recruiting
54
National Institute of Oncology
Budapest, Budapest, Hungary, 1122
Actively Recruiting
55
University of Pécs
Pécs, Hungary, 7632
Actively Recruiting
56
Soroka medical center
Beersheba, Be'er Sheva, Israel, 8410101
Actively Recruiting
57
Rabin Medical Center
Petah Tikva, Petach Tikva, Israel, 4941492
Actively Recruiting
58
Ella Lemelbaum Institute for Immuno-Oncology and Melanoma
Ramat Gan, Ramat Gan, Israel, 5262100
Actively Recruiting
59
Tel Aviv Medical Center
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
60
IRCCS Ospedale San Raffaele
Milan, Milano, Italy, 20132
Actively Recruiting
61
Humanitas Gavazzeni Bergamo
Bergamo, Province of Bergamo, Italy, 24125
Actively Recruiting
62
Clinica Oncologia Delle Marche
Ancona, The Marches, Italy, 60126
Actively Recruiting
63
UOC Immunoterapia Oncologica
Siena, Tuscany, Italy, 53100
Actively Recruiting
64
Christchurch Public Hospital
Christchurch, Christchurch, New Zealand, 8011
Actively Recruiting
65
Auckland City Hospital
Auckland, New Zealand, New Zealand, 1023
Actively Recruiting
66
Nordland Hospital Trust
Bodø, Bodø, Norway, N-8005
Actively Recruiting
67
Oslo University Hospital - The Norwegian Radium Hospital
Oslo, Oslo, Norway, 0310
Actively Recruiting
68
Drammen Hospital
Drammen, Oslofjord, Norway, 3004
Actively Recruiting
69
Uniwersyteckie Centrum Kliniczne
Gdansk, Gdańsk, Poland, 80-952
Actively Recruiting
70
Prezychodnia Lekarska KOMED Roman Karaszewski
Konin, Konin, Poland, 62-500
Actively Recruiting
71
Mazowiecki Szpital Wojewódzki, Siedlckie Centrum Onkologii
Siedlce, Siedlce, Poland, 08-110
Actively Recruiting
72
Maria Sklodowska-Curie National Cancer Research Institute
Warsaw, Warsaw, Poland, 02-781
Actively Recruiting
73
IPO Lisboa
Lisbon, Lisbon District, Portugal, 1099-023
Actively Recruiting
74
Hospital da Luz Lisboa
Lisbon, Lisbon District, Portugal, 1500-650
Actively Recruiting
75
Military Medical Academy- Department of Oncology
Belgrade, Belgrade, Serbia, 11000
Actively Recruiting
76
Cancercare Port Elizabeth - Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, South Africa, 6045
Actively Recruiting
77
University of Pretoria, Steve Biko Academic Hospital
Pretoria, Gauteng, South Africa, 0002
Actively Recruiting
78
The Medical Oncology Centre of Rosebank
Saxonwold, Gauteng, South Africa, 2196
Actively Recruiting
79
Abraham Oncology
Richards Bay, KwaZulu-Natal, South Africa, 3900
Actively Recruiting
80
Curo Oncology
Pretoria, Pretoria, South Africa, 0084
Actively Recruiting
81
Cape Town Oncology Trials
Cape Town, Western Cape, South Africa, 7570
Actively Recruiting
82
TASK Eden
George Central, Western Cape, South Africa, 6530
Actively Recruiting
83
Kyungpook National University Chilgok Hospital
Buk-Gu, Daegu, South Korea, 41404
Actively Recruiting
84
Seoul National University Hospital
Jongno-gu, Seoul, South Korea, 03080
Actively Recruiting
85
H. Germans Trias I Pujol (ICO-Badalona)
Badalona, Badalona, Spain, 08916
Actively Recruiting
86
Hospital Universitari Dexeus
Barcelona, Barcelona, Spain, 08028
Actively Recruiting
87
Vall d' Hebron Institute of Oncology
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
88
San Pedro de Alcántara Hospital
Cáceres, Cáceres, Spain, 10003
Actively Recruiting
89
Hospital Universitario Lucus Augusti
Lugo, Galicia, Spain, 27003
Actively Recruiting
90
Institut Català d'Oncologia Girona (ICO Girona)
Girona, Girona, Spain, 17007
Actively Recruiting
91
University Hospital of Jerez
Jerez de La Frontera (Cádiz), Jerez de La Frontera (Cádiz), Spain, 11407
Actively Recruiting
92
GenesisCare Madrid - Hospital San Francisco de Asís
Madrid, Madrid, Spain, 28002
Actively Recruiting
93
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
94
HM CIOCC
Madrid, Madrid, Spain, 28050
Actively Recruiting
95
Hospital 12 de Octubre
Usera, Madrid, Spain, 28031
Actively Recruiting
96
Hospital Regional Universitario
Málaga, Malaga, Spain, 29011
Actively Recruiting
97
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain, 29010
Actively Recruiting
98
IVO - Fundacion Instituto Valenciano de Oncologia
Valencia, Valencia, Spain, 46009
Actively Recruiting
99
INCLIVA Instituto de Investigación Sanitaria
Valencia, Valencia, Spain, 46010
Actively Recruiting
100
Gävle Sjukhus
Gävle, Gävleborg County, Sweden, 801 88
Actively Recruiting
101
Karolinska University Hospital
Stockholm, Södermanland County, Sweden, 17176
Actively Recruiting
102
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
103
Kantonsspital Graubünden
Chur, Chur, Switzerland, 7000
Actively Recruiting
104
Belfast City Hospital, Belfast Health and Social Care Trust
Belfast, Belfast, United Kingdom, BT9 7AB
Actively Recruiting
105
Guy's and St Thomas' NHS Foundation Trust
London, England, United Kingdom, SE1 9RT
Actively Recruiting
106
Sarah Cannon Research Institute London
London, England, United Kingdom, W1G6AD
Actively Recruiting
107
University Hospital Southampton
Southampton, Hampshire, United Kingdom, SO32 2DA
Actively Recruiting
Research Team
K
Krishna Kaza
CONTACT
J
Juliette Beaulieu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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