NCT06346067Phase 3Active not recruiting

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-04Estimated

Enrollment · participants78Actual

Source updated2026-02-27Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-02-27 · 3 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~470 participants (planned)~~

+ After

78 participants (actual)

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Advanced or Metastatic NRAS-mutant Melanoma

Treatments or interventions studied

NaporafenibDrugAlso known as ERAS-254, LXH254
DacarbazineDrugAlso known as DTIC
TemozolomideDrugAlso known as Temodar, TMZ
TrametinibDrugAlso known as Mekinist

Primary outcomes · main study measures

Read the study measures

measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2; description: Incidence and severity of treatment-emergent AEs and serious AEs; timeFrame: Assessed up to 6 months from time of first dose; measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2; description: Objective response rate (ORR) based on assessment of radiographic imaging RECIST v1.1; timeFrame: Assessed up to 6 months from time of first dose; measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2; description: Maximum plasma concentration of ERAS-254 and trametinib; timeFrame: Study Day 1 up to Day 29; measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2; description: Time to achieve maximum plasma concentration of ERAS-254 and trametinib; timeFrame: Study Day 1 up to Day 29; measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2; description: Area under the plasma concentration-time curve; timeFrame: Study Day 1 up to Day 29; 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); description: * Progression free survival (PFS) based on assessment of radiographic imaging per RECIST v1.1 * Survival status; timeFrame: Assessed up to 24 months from time of first dose

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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