Brief Summary

The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.

Conditions

• Advanced Melanoma

Intervention / Treatment

• Drug: EIK1001
• Drug: Pembrolizumab (KEYTRUDA® )

Primary Outcome Measures

• Progression Free Survival (PFS) (up to 5 years)
  Progression-free survival (PFS) is defined as the time from the date of randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
• Overall survival (OS) (up to 5 years)
  Overall survival (OS) defined as the time from randomization to death due to any cause.
• Objective Response (OR) (Dose Optimization Only) (up to 5 years)
  Objective Response (OR; defined as participants who demonstrate confirmed complete response \[CR\] or partial response \[PR\] by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1 as assessed by the Investigator) (Dose Optimization Only).
• Adverse Events (AEs) (Dose Optimization Only) (up to 2.5 years)
  Adverse events (AEs), and discontinuation of study treatment due to an AE (Dose Optimization Only). An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Countries

Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Norway, Poland, Portugal, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States

Locations and Investigators

• Aalborg University Hospital, Aalborg, Denmark
  • Adam Andrzej, Luczak
• Region Midtjylland, Aarhus N, Denmark
  • Henrik, Schmidt
• National Oncological Medical Center EOOD, Sofia, Bulgaria
  • Assia, Konsulova-Kirova
• Vestre Viken HF, Drammen, Norway
  • Alina, Porojnicu
• Nordlandssykehuset HF, Bodo, Norway
  • Bård, Mannsåker
• Oslo University Hospital HF, Oslo, Norway
  • Marta, Nyakas
• HUS-Yhtymae, Helsinki, Finland
  • Micaela, Hernberg
• Tampere University Hospital, Tampere, Finland
  • Tanja, Skyttä
• Oulu University Hospital, Oulu, Finland
  • Sanna, Iivanainen
• Region Gaevleborg, Gavle, Sweden
  • Ilke, Cikman
• Karolinska University Hospital, Solna, Sweden
  • Hanna, Eriksson
• Medical University Of Graz, Graz, Austria
  • Ingrid, Wolf
• Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur, Yvoir, Belgium
  • Laurence, Faugeras
• Algemeen Ziekenhuis Groeninge, Kortrijk, Belgium
  • Veronique, Buyse
• UZ Leuven, Leuven, Belgium
  • Oliver, Bechter
• Antwerp University Hospital, Edegem, Belgium
  • Marika, Rasschaert
• Cliniques Universitaires Saint-Luc, Sint-Lambrechts-Woluwe, Belgium
  • Jean-François, Baurain
• Vitaz, Sint-Niklaas, Belgium
  • Ines, DELEU
• Universitaet Leipzig, Leipzig, Germany
  • Jan C, Simon
• University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  • Christoffer, Gebhardt
• Fachklinik Hornheide e.V., Muenster, Germany
  • Carmen, Loquai
• SRH Wald-Klinikum Gera GmbH, Gera, Germany
  • Sabine, Sell
• Muehlenkreiskliniken AöR, Minden, Germany
  • Ralf, Gutzmer
• Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH, Buxtehude, Germany
  • Peter, Mohr
• Universitaetsklinikum Schleswig-Holstein AöR, Luebeck, Germany
  • Evelyn, Gaffal
• Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR, Dresden, Germany
  • Friedegund, Meier
• Universitaetsklinikum Erlangen AöR, Erlangen, Germany
  • Carola, Berking
• Heidelberg University, Mannheim, Germany
  • Jochen, Utikal
• HELIOS Klinikum Erfurt GmbH, Erfurt, Germany
  • Rudolf, Herbst
• Charite Universitaetsmedizin Berlin KöR, Berlin, Germany
  • Thomas, Eigentler
• Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Mainz, Germany
  • Stephan, Grabbe
• Universitaetsklinikum Tuebingen AöR, Tuebingen, Germany
  • Andreas, Meiwes
• Universitaetsklinikum Schleswig-Holstein AöR, Kiel, Germany
  • Katharina C, Kähler
• Universitaetsklinikum Wuerzburg AöR, Wuerzburg, Germany
  • Anja, Gesierich
• Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E., Coimbra, Portugal
  • Inês, Ferreira Gomes
• Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E., Lisbon, Portugal
  • Patrícia, Pereira
• Hospital Da Luz S.A., Lisbon, Portugal
  • Gonçalo, Fernandes
• Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E., Porto, Portugal
  • Dânia, Marques
• I.F.O. Istituti Fisioterapici Ospitalieri, Rome, Italy
  • Michelangelo, Russillo
• Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria, Alexandria, Italy
  • Federica, Grosso
• Ospedale “San Vincenzo”, Taormina, Italy
  • Francesco, Ferraù
• Azienda Universitaria Ospedaliera Consorziale Policlinico Bari, Bari, Italy
  • Marco Gaetano, Tucci
• Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy
  • Michele, Del Vecchio
• IRCCS Ospedale Policlinico San Martino, Genoa, Italy
  • Francesco, Spagnolo
• Azienda Ospedaliera Universitaria Senese, Siena, Italy
  • Anna Maria, Di Giacomo
• Cliniche Gavazzeni S.p.A., Bergamo, Italy
  • Laura, Pala
• Casa Sollievo Della Sofferenza, San Giovanni Rotondo, Italy
  • Gabriele, Di Maggio
• Azienda Provinciale Per I Servizi Sanitari, Trento, Italy
  • Sonia, Brugnara
• Istituto Oncologico Veneto, Padova, Italy
  • Jacopo, Pigozzo
• Azienda Ospedaliero Universitaria Delle Marche, Ancona, Italy
  • Rossana, Berardi

And 43 other sites.

Study Officials

• Etah Kurland (Study Director) — Eikon Therapeutics
• Muaz Sadeia (Study Director) — Eikon Therapeutics