A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Erasca, Inc.
- Study ID
- NCT06346067
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Advanced or Metastatic NRAS-mutant Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Naporafenib — DRUGNaporafenib (ERAS-254) is an experimental Pan-Raf inhibitor
- Dacarbazine — DRUGDacarbazine IV - Day 1
- Temozolomide — DRUGTemozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle
- Trametinib — DRUGTrametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
Study Details
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).
Key Dates
- Start date
- Apr 29, 2024
- Status verified
- Feb 2026
- Primary completion
- Apr 30, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 78 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Stage 1 Dose selection Lead-in Arm 1Naporafenib + Trametinib Naporafenib (ERAS-254) 100 mg administered orally twice daily (BID) Trametinib 1 mg once daily (QD)
- Experimental: Stage 1 Dose selection Lead-in Arm 2Naporafenib + Trametinib Naporafenib (ERAS-254) 400 mg administered orally twice daily (BID) Trametinib 0.5 mg once daily (QD)
- Active Comparator: Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapyTrametinib 2 mg once daily (QD)
- Experimental: Stage 2 Arm ANaporafenib + Trametinib Naporafenib (ERAS-254) BID oral administration with Trametinib QD at the dose selected in Stage 1
- Active Comparator: Stage 2 Arm B - Physician's Choice* Dacarbazine 1000 mg/m2 intravenously (IV) on Day 1 of each 21-day cycle OR * Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle OR * Trametinib monotherapy, 2 mg PO QD
Primary Outcome Measure
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 [ Time Frame: Assessed up to 6 months from time of first dose ]