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drugset / Trial / NCT06346067

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

NCT06346067 ↗

Phase 3 Active not recruiting 78 enrolled Erasca, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2024-04-29
Primary completion
2028-04
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dacarbazine Small molecule 1000 mg/m2 Intravenous
Subject Naporafenib Small molecule 100 mg Oral
Subject Naporafenib Small molecule 400 mg Oral
Comparator Temozolomide Small molecule 200 mg/m2 Oral
Subject Trametinib Small molecule 0.5 mg Oral
Subject Trametinib Small molecule 1 mg Oral
Subject Trametinib Small molecule 2 mg Oral

Indications

melanoma