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
Résumé de l'étude
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)
Intervention étudiée
Patients with previously untreated advanced melanoma
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
PRA Switzerland Lange Gasse 15, 4002 Basel, Switzerland
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Egle Ramelyte
+41 43 253 76 59
Egle.Ramelyte@clutterusz.chUniversitätsspital Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
28.01.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible