A study of Naporafenib (investigational drug) with Trametinib in patients with advanced melanoma (type of skin cancer) compared to another treatment chosen by the physician.
Résumé de l'étude
This phase III study is being conducted to determine whether the combination of Naporafenib with Trametinib is more effective when taken together. The study consists of two stages: Stage 1: In stage 1, the best dose of Naporafenib and Trametinib taken together will be determined by examining the side effects, tolerability, and efficacy of Naporafenib and Trametinib taken together compared to Trametinib taken alone. Stage 2: In stage 2, the efficacy of Naporafenib and Trametinib taken together will be compared to standard therapy. In total, up to 470 eligible patients will receive the investigational drug(s) in 2 stages.
(BASEC)
Intervention étudiée
The investigational drug(s) will be administered in continuous 28-day cycles (21-day cycles for Dacarbazine), until there is a deterioration of the disease (radiologically documented), an intolerance, a withdrawal of consent for further study treatment, or a decision by the investigator to discontinue treatment, with the first occurring event being decisive.
(BASEC)
Maladie en cours d'investigation
Unresectable or metastatic cutaneous skin cancer
(BASEC)
- Willing and able to provide written informed consent from the investigator - Age ≥ 18 years - Confirmed unresectable or metastatic cutaneous melanoma - Evidence of an NRAS mutation (tumor tissue or blood; testing in the laboratory of the cantonal hospital) prior to the first administration of the investigational drugs. Archived tumor tissue obtained within 5 years prior to study entry must be demonstrably available at the time of screening. (BASEC)
Critères d'exclusion
- Patients with a special form of skin cancer: choroidal melanoma or mucosal melanoma - Prior treatment with an ERK, MEK, RAF, or RAS inhibitor - Impairment of gastrointestinal function or a gastrointestinal disease that could significantly affect the absorption of the investigational drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small intestine resection) (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Erasca, Inc.
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Simone Küng Stimolo
+41 (0)78 687 67 19
simone.stimolo@clutterstimolo-pharma-consulting.chStimolo Pharma Consulting GmbH
(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
20.12.2024
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
A RANDOMIZED, OPEN-LABEL PHASE 3 STUDY IN PATIENTS WITH PREVIOUSLY TREATED UNRESECTABLE OR METASTATIC NRAS MUTANT CUTANEOUS MELANOMA COMPARING THE COMBINATION OF NAPORAFENIB + TRAMETINIB TO PHYSICIAN’S CHOICE OF THERAPY (DACARBAZINE, TEMOZOLOMIDE OR TRAMETINIB MONOTHERAPY) WITH A DOSE OPTIMIZATION LEAD-IN [SEACRAFT-2] (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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