protocolSection identificationModule nctId: NCT06346067, orgStudyIdInfo id: ERAS-254-02, briefTitle: A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Erasca, Inc., class: INDUSTRY, descriptionModule briefSummary: Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2.Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy)., conditionsModule conditions: Advanced or Metastatic NRAS-mutant Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: Naporafenib, interventions name: Dacarbazine, interventions name: Temozolomide, interventions name: Trametinib, outcomesModule primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 2: To compare PFS and OS for patients who are randomized to receive the combination of naporafenib + trametinib to that of patients who receive physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy), secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Plasma concentration (Cmax):Stage 1 only, secondaryOutcomes measure: Area under the curve (AUC):Stage 1 only, secondaryOutcomes measure: Quality of Life: To assess disease and treatment-related QOL in patients with NRASm melanoma., otherOutcomes measure: Duration of Response (DOR) for CNS disease in participants, otherOutcomes measure: Overall Response Rate (ORR) for CNS disease in participants, otherOutcomes measure: Disease Control Rate (DCR) for CNS disease in participants, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SCRI Oncology Partners (formerly Tennessee Oncology), city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False