A multicenter, randomized, double-blind, comparator-controlled, Phase II/III study to assess the safety and efficacy of EIK1001 and Pembrolizumab compared to placebo and Pembrolizumab as first-line therapy in participants with advanced melanoma
Descrizione riassuntiva dello studio
Melanoma is the sixth most common cancer in Switzerland, accounting for about 4.1% of all new cancer cases. In participants with advanced melanoma, the 5-year survival rate is approximately 40%. Melanoma is resistant to currently available treatments, and there is an urgent need to develop more effective therapies. EIK1001 is a drug in development for the treatment of melanomas and has been shown to enhance the immune system's mechanisms to fight cancer cells. The aim of this study is to develop a novel combination therapy in which EIK1001 + Pembrolizumab will be administered to participants with advanced melanoma. This study targets participants aged 18 years and older with inoperable melanoma at stage 3 and stage 4 (advanced), who must not have received prior systemic therapy for advanced melanoma. The study requires participant involvement for approximately 10 years, with a treatment duration of up to two years. The frequency of visits until week 27 is once a week. The frequency then decreases to once every 3 weeks. Approximately 740 participants will be enrolled in this study. Participants will go through the following sections: pre-screening; treatment; an active follow-up period consisting of a visit at the end of treatment, a visit for safety follow-up, and a contact for survival follow-up. In the treatment section, participants will receive EIK1001 or a placebo as an intravenous (i.v.) infusion for 30 minutes, followed by a 60-minute break. Pembrolizumab will be administered over 30 minutes as an i.v. infusion.
(BASEC)
Intervento studiato
Patients with previously untreated advanced melanoma
(BASEC)
Malattie studiate
Advanced melanoma
(BASEC)
1. Over 18 years old 2. Has a life expectancy of at least 3 months 3. Has a histologically or cytologically confirmed metastatic melanoma of stage 3 or stage 4 (BASEC)
Criteri di esclusione
1. Melanoma originating from the eye 2. Participant is enrolled in another study or has received treatment within 4 weeks or 5 half-lives of EIK1001 or placebo. 3. Participant has received systemic therapy for advanced melanoma prior to the first dose of EIK1001 or placebo (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
PRA Switzerland Lange Gasse 15, 4002 Basel, Switzerland
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Egle Ramelyte
+41 43 253 76 59
Egle.Ramelyte@clutterusz.chUniversitätsspital Zürich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
28.01.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
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non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
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Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
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