Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346067
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-17
Brief Title:
A Study to Assess Naporafenib ERAS-254 Administered With Trametinib in Patients With NRAS-mutant Melanoma SEACRAFT-2
Sponsor:
Erasca Inc
Organization:
Erasca Inc
Study Overview
Official Title:
A Randomized Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib Trametinib to Physicians Choice of Therapy Dacarbazine Temozolomide or Trametinib Monotherapy With a Dose Optimization lead-in SEACRAFT-2
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 physicians choice of therapy dacarbazine temozolomide or trametinib monotherapy
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 physicians choice of therapy dacarbazine temozolomide or trametinib monotherapy
Detailed Description:
SEACRAFT-2 is a global Phase III open-label randomized study to assess the efficacy and safety of naporafenib administered with trametinib compared to physicians choice of therapy dacarbazine temozolomide or trametinib monotherapy in patients with unresectable or metastatic NRAS mutant melanoma who have progressed on or are intolerant to an anti-programmed death-1 ligand 1 PD 1L1-based regimen The study will consist of 2 stages dose optimization in Stage 1 and the Phase 3 portion in Stage 2
A total of approximately 470 eligible patients will be randomized to receive study drugs in this study across 2 stages
A total of approximately 470 eligible patients will be randomized to receive study drugs in this study across 2 stages
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None