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.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Erasca, Inc.
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Simone Küng Stimolo
+41 (0)78 687 67 19
simone.stimolo@clutterstimolo-pharma-consulting.chStimolo Pharma Consulting GmbH
(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
20.12.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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