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.
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Zurich
(BASEC)
Sponsor
Erasca, Inc.
(BASEC)
Contact
Contact Person Switzerland
Simone Küng Stimolo
+41 (0)78 687 67 19
simone.stimolo@clutterstimolo-pharma-consulting.chStimolo Pharma Consulting GmbH
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
20.12.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
not available
Link to the results in the primary register
not available