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
Zusammenfassung der Studie
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)
Untersuchte Intervention
Patients with previously untreated advanced melanoma
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Zürich
(BASEC)
Sponsor
PRA Switzerland Lange Gasse 15, 4002 Basel, Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. Egle Ramelyte
+41 43 253 76 59
Egle.Ramelyte@clutterusz.chUniversitätsspital Zürich
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
28.01.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Registrierungsdatum
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Einschluss des ersten Teilnehmers
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Sekundäre Sponsoren
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Weitere Kontakte
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Sekundäre IDs
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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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Weitere Informationen zur Studie
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Ergebnisse der Studie
Zusammenfassung der Ergebnisse
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Link zu den Ergebnissen im Primärregister
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