Clinical trial • Phase II/III • Oncology

Pembrolizumab for Advanced melanoma

Phase II/III trial of Pembrolizumab for Advanced melanoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced melanoma
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody|Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
17-05-2024
First CTIS Authorization Date
18-11-2024

Trial design

Randomised, placebo + pembrolizumab 200 mg versus eik1001 + pembrolizumab 200 mg (arms described as placebo + pembrolizumab 200 mg; eik1001 selected dose + pembrolizumab 200 mg).-controlled, adaptive Phase II/III trial in Denmark, Bulgaria, Norway and others.

Randomised
Yes
Comparator
Placebo + pembrolizumab 200 mg versus EIK1001 + pembrolizumab 200 mg (arms described as placebo + pembrolizumab 200 mg; EIK1001 Selected Dose + pembrolizumab 200 mg).
Adaptive
True, adaptive elements include a Dose Optimization stage with participants randomized 1:1:1 across 3 arms to identify a selected dose of EIK1001, a Phase 2 dose selection (ongoing participants from Dose Optimization continue and new participants randomized to selected dose vs placebo), and a Phase 3 expansion at the selected dose. The design includes dose optimization and dose selection interim analyses and allows participants in the unselected arm to continue on study if there is clinical benefit.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
540
Trial Duration For Participant
730

Eligibility

Recruits 540 paediatric patients.

Pregnancy Exclusion
Participant is pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study.
Vulnerable Population
Adolescents are included (participants ≥ 12 years). The protocol requires written informed consent/assent: participants must be willing and able to provide written informed consent/assent; assent and parental/guardian consent arrangements are provided for minors (assent forms and parental ICFs are included in country-specific documents). Country-specific assent/parental ICFs and materials are provided (examples in the submission: Belgium, Portugal, Italy, Spain, Germany, Czechia, Bulgaria, Norway, Finland, Poland and others) to handle consent/assent for adolescent participants.

Inclusion criteria

  • {"criterion_text":"- 1. Be ≥ 12 years of age on the day of signing of informed consent/assent.\n- 10. 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).\n- 11. Be willing and able to provide written, informed consent/assent for the study.\n- 2. Have a life expectancy of at least 3 months.\n- 3. 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.\n- 4. 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.\n- 5. Have known BRAF V600 mutation status or consent/assent to BRAF V600 mutation testing per local institutional standards during the Screening Period\n- 6. Have an ECOG Performance Status of 0 to 1 for participants ≥ 18 years of age, Lansky Performance score (LPS) score ≥ 50 (for participants 12 to 15), or Karnofsky Performance Status (KPS) score ≥ 50 for participants 16 to < 18 years of age.\n- 7. 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.\n- 8. Have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication (applies to WOCBP).\n- 9. 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)."}

Exclusion criteria

  • {"criterion_text":"- Has melanoma of ocular origin.\n- 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.\n- 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.\n- There is a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- There are any active infections requiring therapy.\n- There is uncontrolled human immunodeficiency virus (HIV) infection. HIV-infected participants with well-controlled HIV may enroll.\n- 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:\n- 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\n- Known psychiatric or substance abuse disorder that would interfere with cooperation with study requirements.\n- There is a known history of regular illicit drug use and/or recent history (within the last year) of substance abuse (including alcohol).\n- Participant is pregnant, breastfeeding, or planning to conceive or father children within the projected duration of the study.\n- 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.\n- Participant is currently receiving medications known to be strong inhibitors or inducers of CYP3A4 and CYP1A2.\n- 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.\n- Experienced a ≥ Grade 3 AE while receiving prior anti PD 1 therapy.\n- Has had major surgery (< 3 weeks prior to the first dose).\n- Has received a live-virus vaccination within 30 days of the first dose of study treatment.\n- Has a known history of prior malignancy, unless the participant has undergone potentially curative therapy with no evidence of disease recurrence for 5 years.\n- 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.\n- There is a mean resting QTcF > 470 ms on triplicate electrocardiograms"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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), adverse events (AEs), and discontinuation of study treatment due to an AE (Dose Optimization).","definition_or_measurement_approach":"OR defined as participants who demonstrate confirmed CR or PR by RECIST v1.1 as assessed by the Investigator; AEs and discontinuation due to AE recorded. (Dose Optimization)"}
  • {"endpoint_text":"- PFS defined as the time from randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"PFS: time from randomization to documented progressive disease per RECIST 1.1 by blinded independent central review (BICR) or death from any cause, whichever occurs first."}
  • {"endpoint_text":"- OS defined as the time from randomization to death due to any cause","definition_or_measurement_approach":"OS: time from randomization to death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- AEs and discontinuation of study treatment due to any AE.","definition_or_measurement_approach":"Adverse events collected and treatment discontinuations due to AE recorded."}
  • {"endpoint_text":"- OR and DOR; OR defined as participants who demonstrate confirmed CR or PR; DOR defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, according to RECIST 1.1 by BICR.","definition_or_measurement_approach":"OR per RECIST 1.1 by BICR; DOR = time from first documented CR/PR to progression or death per RECIST 1.1 by BICR."}
  • {"endpoint_text":"- PFS, OR, and DOR according to RECIST 1.1 by Investigator.","definition_or_measurement_approach":"PFS, OR, DOR assessed per RECIST 1.1 by the Investigator (investigator-assessed efficacy endpoints)."}
  • {"endpoint_text":"- DOR per RECIST 1.1 by Investigator (Dose Optimization).","definition_or_measurement_approach":"DOR assessed per RECIST 1.1 by Investigator (Dose Optimization)."}
  • {"endpoint_text":"- PFS per RECIST 1.1 by Investigator and OS (Dose Optimization).","definition_or_measurement_approach":"PFS per RECIST 1.1 by Investigator and OS; noted as Dose Optimization endpoints (not part of dose selection interim analysis)."}

Recruitment

Planned Sample Size
540
Recruitment Window Months
65
Consent Approach
Written informed consent/assent is required. Participants ≥12 years must provide written informed consent/assent; adolescent assent forms and parental/guardian consent forms are provided for minors. Country-specific subject information and informed consent forms (and assent/parental forms) are submitted in multiple languages (examples include Danish, Bulgarian, Norwegian, Finnish, Swedish, German, Portuguese, Italian, Spanish, Czech, Hungarian, Polish, French, Dutch), and pregnancy follow-up and optional future research consent modules are provided where applicable.

Geography

Total Number Of Sites
93
Total Number Of Participants
715

Denmark

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
431
Number Of Sites
2
Number Of Participants
34

Sites

Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Contact Person Name
Adam Andrzej Luczak
Contact Person Email
adal@rn.dk
Site Name
Region Midtjylland
Department Name
Department of Oncology
Contact Person Name
Henrik Schmidt
Contact Person Email
henrschm@rm.dk

Bulgaria

Earliest CTIS Part Ii Submission Date
05-12-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
411
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
National Oncological Medical Center EOOD
Department Name
Medical Oncology Clinic
Contact Person Name
Assia Konsulova-Kirova
Contact Person Email
akonsoulova@sbaloncology.bg

Norway

Earliest CTIS Part Ii Submission Date
19-12-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
397
Number Of Sites
3
Number Of Participants
39

Sites

Site Name
Vestre Viken HF
Department Name
Department of Oncology
Contact Person Name
Alina Porojnicu
Contact Person Email
alinacp@vestreviken.no
Site Name
Nordlandssykehuset HF
Department Name
Department of Cancer
Contact Person Name
Bård Mannsåker
Site Name
Oslo University Hospital HF
Department Name
Dept of Oncology
Contact Person Name
Marta Nyakas
Contact Person Email
MARNYA@ous-hf.no

Finland

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
406
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
HUS-Yhtymae
Department Name
Comprehensive Cancer Center, Dept of Oncology
Contact Person Name
Micaela Hernberg
Contact Person Email
Micaela.Hernberg@hus.fi
Site Name
Tampere University Hospital
Department Name
Department of Oncology
Contact Person Name
Tanja Skyttä
Contact Person Email
tanja.skytta@pirha.fi
Site Name
Oulu University Hospital
Department Name
Cancer Center
Contact Person Name
Sanna Iivanainen
Contact Person Email
Sanna.iivanainen@pohde.fi

Sweden

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
403
Number Of Sites
2
Number Of Participants
33

Sites

Site Name
Region Gaevleborg
Department Name
Oncology department
Contact Person Name
Ilke Cikman
Contact Person Email
Ilke.cikman@regiongavleborg.se
Site Name
Karolinska University Hospital
Department Name
Head-throat-lung and skin cancer department
Contact Person Name
Hanna Eriksson

Austria

Earliest CTIS Part Ii Submission Date
20-12-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
395
Number Of Sites
1
Number Of Participants
19

Sites

Site Name
Medical University Of Graz
Department Name
University Hospital for Dermatology and Venereolog
Contact Person Name
Ingrid Wolf
Contact Person Email
ingrid.wolf@medunigraz.at

Belgium

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
400
Number Of Sites
6
Number Of Participants
41

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Contact Person Name
Laurence Faugeras
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Oncology
Contact Person Name
Veronique Buyse
Contact Person Email
veronique.buyse@azgroeninge.be
Site Name
UZ Leuven
Department Name
General Medical Oncology
Contact Person Name
Oliver Bechter
Contact Person Email
oliver.bechter@uzleuven.be
Site Name
Antwerp University Hospital
Department Name
Oncology
Contact Person Name
Marika Rasschaert
Contact Person Email
Marika.Rasschaert@uza.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Jean-François Baurain
Site Name
Vitaz
Department Name
Medical Oncology
Contact Person Name
Ines DELEU
Contact Person Email
Ines.deleu@vitaz.be

Germany

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
428
Number Of Sites
16
Number Of Participants
103

Sites

Site Name
Universitaet Leipzig
Department Name
Department of Dermatology, Venereology and Allergology
Contact Person Name
Jan C Simon
Contact Person Email
derma@uniklinik-leipzig.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Dermatology and Venerology
Contact Person Name
Christoffer Gebhardt
Contact Person Email
ch.gebhardt@uke.de
Site Name
Fachklinik Hornheide e.V.
Department Name
Department of Dermatology
Contact Person Name
Carmen Loquai
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Zentrum für klinische Studien
Contact Person Name
Sabine Sell
Contact Person Email
Sabine.sell@srh.de
Site Name
Muehlenkreiskliniken AöR
Department Name
Department of Dermatology, Venereology, Allergology and Phlebology
Contact Person Name
Ralf Gutzmer
Site Name
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
Department Name
Department of Dermatology
Contact Person Name
Peter Mohr
Contact Person Email
Peter.Mohr@elbekliniken.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Department of Dermatology
Contact Person Name
Evelyn Gaffal
Contact Person Email
Evelyn.gaffal@uksh.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Skin Tumor Center
Contact Person Name
Friedegund Meier
Contact Person Email
friedegund.meier@ukdd.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Department of Dermatology
Contact Person Name
Carola Berking
Contact Person Email
Carola.Berking@uk-erlangen.de
Site Name
Heidelberg University
Department Name
Department of Dermatology, Venereology and Allergology
Contact Person Name
Jochen Utikal
Contact Person Email
Jochen.Utikal@umm.de
Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Klinik für Hautkrankheiten und Allergologie
Contact Person Name
Rudolf Herbst
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Dermatology, Venerology and Allergology
Contact Person Name
Thomas Eigentler
Contact Person Email
thomas.eigentler@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Department of Dermatology
Contact Person Name
Stephan Grabbe
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department of Dermatology
Contact Person Name
Andreas Meiwes
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
Department Name
Department of Dermatology
Contact Person Name
Katharina C Kähler
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Department of Dermatology, Venereology and Allergology
Contact Person Name
Anja Gesierich
Contact Person Email
Gesierich_a@ukw.de

Portugal

Earliest CTIS Part Ii Submission Date
13-11-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
432
Number Of Sites
4
Number Of Participants
26

Sites

Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Oncology
Contact Person Name
Inês Ferreira Gomes
Contact Person Email
3952@ipocoimbra.min-saude.pt
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Patrícia Pereira
Contact Person Email
pmsilva@ipolisboa.min-saude.pt
Site Name
Hospital Da Luz S.A.
Department Name
Oncology
Contact Person Name
Gonçalo Fernandes
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncology
Contact Person Name
Dânia Marques

Italy

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
417
Number Of Sites
14
Number Of Participants
90

Sites

Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOSD Sarcomi e Tumori rari
Contact Person Name
Michelangelo Russillo
Contact Person Email
michelangelo.russillo@ifo.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
SSD Mesotelioma, Melanoma e Tumori Rari
Contact Person Name
Federica Grosso
Contact Person Email
federica.grosso@ospedale.al.it
Site Name
Ospedale “San Vincenzo”
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Francesco Ferraù
Contact Person Email
ferrau@oncologiataormina.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
U.O.C Oncologia Medica
Contact Person Name
Marco Gaetano Tucci
Contact Person Email
marco.tucci@uniba.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SS Oncologia Medica Melanomi
Contact Person Name
Michele Del Vecchio
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
U. O. Oncologia Medica 2
Contact Person Name
Francesco Spagnolo
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
U.O.C. Immunoterapia Oncologica
Contact Person Name
Anna Maria Di Giacomo
Site Name
Cliniche Gavazzeni S.p.A.
Department Name
Unità Oncologia Medica
Contact Person Name
Laura Pala
Contact Person Email
laura.pala@gavazzeni.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
UOC Oncologia
Contact Person Name
Gabriele Di Maggio
Contact Person Email
gooncogabry@gmail.com
Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
U.O. Oncologia Medica
Contact Person Name
Sonia Brugnara
Contact Person Email
sonia.brugnara@apss.tn.it
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 2
Contact Person Name
Jacopo Pigozzo
Contact Person Email
jacopo.pigozzo@iov.veneto.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Dipartimento di medicina Interna
Contact Person Name
Rossana Berardi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Vincenzo Russo
Contact Person Email
russo.vincenzo@hsr.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Dipartimento di Oncologia ed Ematologia
Contact Person Name
Roberta Depenni
Contact Person Email
depenni.roberta@aou.mo.it

Czechia

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
620
Number Of Sites
4
Number Of Participants
26

Sites

Site Name
Sanatorium profesora Arenbergera
Contact Person Name
Petr Arenberger
Contact Person Email
avemedica@email.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Contact Person Name
Jindřich Kopecký
Contact Person Email
jindrich.kopecky@fnhk.cz
Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Department of clinical oncology
Contact Person Name
Radek Lakomý
Contact Person Email
radek.lakomy@mou.cz

Hungary

Earliest CTIS Part Ii Submission Date
13-11-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
432
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Dermatooncology
Contact Person Name
Tímea Balatoni
Contact Person Email
balatoni.timea@oncol.hu
Site Name
University Of Pecs
Department Name
Clinical Center, Dermatology, Venereology and Oncodermatology Clinic
Contact Person Name
Zsuzsanna Lengyel
Contact Person Email
lengyel.zsuzsanna@pte.hu

Poland

Earliest CTIS Part Ii Submission Date
05-12-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
410
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
I Przychodnia Lekarska Komed Roman Karaszewski
Department Name
N\A
Contact Person Name
Bogusława Karaszewska
Contact Person Email
komed.badania@gmail.com
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej i Radioterapii
Contact Person Name
Lubomir Bodnar
Contact Person Email
bbk@szpital.siedlce.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej
Contact Person Name
Kamil Drucis
Contact Person Email
Kamil.drucis@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Oddział Chemioterapii Dziennej
Contact Person Name
Wiesław Bal
Contact Person Email
Wieslaw.bal@io.gliwice.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Nowotworów Tkanek Miękkich Kości i Czerniaków
Contact Person Name
Anna Małgorzata Czarnecka
Contact Person Email
miesaki@nio.gov.pl

Spain

Earliest CTIS Part Ii Submission Date
19-12-2024
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
393
Number Of Sites
19
Number Of Participants
124

Sites

Site Name
Hospital Universitario Lucus Augusti
Department Name
Oncology
Contact Person Name
Begona Campos Balea
Contact Person Email
bcamposbalea@hotmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Guillermo de Velasco Oria de Rueda
Contact Person Email
gdvelasco.gdv@gmail.com
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Contact Person Name
Elisabet Bujons Buscaron
Contact Person Email
mruiz@idibgi.org
Site Name
Hospital Universitario Regional De Malaga
Department Name
Medical Oncology
Contact Person Name
Miguel Ángel Berciano Guerrero
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Juan Rodriguez Moreno
Contact Person Email
jfrodriguez@hmhospitales.com
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Ana Maria Arance Fernandez
Contact Person Email
amarance@clinic.cat
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Medical Oncology
Contact Person Name
José Luís Manzano Mozo
Contact Person Email
jmanzano@iconcologia.net
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Contact Person Name
Pablo Cerezuela Fuentes
Contact Person Email
pcerezuelaf@seom.org
Site Name
Instituto Multidisciplinar De Oncologia S.A.
Department Name
Oncology
Contact Person Name
José Ángel García
Contact Person Email
jose.garcia@genesiscare.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Iván Márquez Rodas
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Contact Person Name
Manuel Zalabardo Aguilar
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Contact Person Name
María Gonzalez Cao
Contact Person Email
cesparre@oncorosell.com
Site Name
Hospital San Pedro De Alcantara
Department Name
Oncology
Contact Person Name
Pablo Ayala de Miguel
Contact Person Email
pablo.ayala@salud-juntaex.es
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Maria José Juan Fita
Contact Person Email
contratosestudios@fivo.org
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Marta Sotelo García
Contact Person Email
marta.sotelo@scsalud.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Contact Person Name
Maria Teresa Curiel Garcia
Site Name
Hospital De Jerez De La Frontera
Department Name
Oncology
Contact Person Name
Regina Garcia Galinda
Contact Person Email
reginagarciagalindo@gmail.com
Site Name
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Department Name
Oncology
Contact Person Name
Inés Gonzalez Barrallo
Contact Person Email
uicec@incliva.es

France

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
620
Number Of Sites
11
Number Of Participants
70

Sites

Site Name
Centre Hospitalier De La Cote Basque
Department Name
Oncology
Contact Person Name
Fabio Da Silva
Contact Person Email
fda-silva@ch-cotebasque.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Dermatology
Contact Person Name
Anne-Benedicte Duval-Modeste
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Dermatology
Contact Person Name
Caroline Dutriaux
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Melanie Saint-Jean
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Dermatology
Contact Person Name
Henri Montaudié
Contact Person Email
Montaudie.h@chu-nice.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Dermatology, allergology, photobiology
Contact Person Name
Julie Charles
Contact Person Email
jcharles@chugrenoble.fr
Site Name
Assistance Publique Hopitaux De Paris (Boulogne-Billancourt)
Department Name
General and Oncologic Dermatology
Contact Person Name
Philippe Saiag
Contact Person Email
Philippe.saiag@uvsq.fr
Site Name
Hospices Civils De Lyon
Department Name
Dermatology
Contact Person Name
Stephane Dalle
Contact Person Email
Stephane.dalle@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Dermatology
Contact Person Name
Laurent Mortier
Contact Person Email
Laurent.mortier@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris Cedex 18)
Department Name
Dermatology
Contact Person Name
Florence Brunet-Possenti
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Dermatology and skin cancer unit
Contact Person Name
Caroline Gaudy-Marqueste
Contact Person Email
Caroline.gaudy@ap-hm.fr

Sponsor

Primary sponsor

Full Name
Eikon Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Clinical Trial Contracting, Central Imaging, operational duties listed in sponsor third parties
Name
Veeda Clinical Research Limited
Responsibilities
Clinical/site services (listed as third party)
Name
ClinChoice
Responsibilities
Third-party operational support (listed as third party)

Third parties

  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursements","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"ePRO","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"QP Services, Pack, Label, Distribution","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Ancillare Europe B.V.","duties_or_roles":"Ancillary Supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"DMC services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scisafe Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"ClinChoice","duties_or_roles":"","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eConsent","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Quanterix Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"Argus Safety Database","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Canopy Biosciences LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Clinical Trial Contracting, Central Imaging; other operational duties","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PEMBROLIZUMAB
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Marketing authorisation present (prodAuthStatus indicates authorised product information present)
Starting Dose
200 mg
Maximum Dose
7000 mg (max total dose amount)
Investigational Product Name
Matching placebo
Modality
Other
Investigational Product Name
EIK1001 solution for injection 1.0 mg/mL free base equivalent
Active Substance
Resiquimod sulfate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Investigational product (PRD11186932)
Dose Levels
0.60 mg/m2|0.75 mg/m2
Dose Escalation Increase
0.60 mg/m2 -> 0.75 mg/m2
Combination Treatment
Yes

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