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NCT06346067 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)
A Phase 3 study of Advanced or Metastatic NRAS-mutant Melanoma, sponsored by Erasca.
- Active
- Registry status
- Phase 3
- Development phase
- 78
- Enrollment target
- 20
- Study locations
NCT06346067: Active Phase 3 study of Advanced or Metastatic NRAS-mutant Melanoma, sponsored by Erasca.
NCT06346067 is a Phase 3 study of Advanced or Metastatic NRAS-mutant Melanoma that is active but no longer recruiting, run by Erasca. The registered enrollment target is 78 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06346067, a Phase 3 study of Advanced or Metastatic NRAS-mutant Melanoma, is active but no longer recruiting, sponsored by Erasca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 78 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Incidence and severity of treatment-emergent AEs and serious AEs
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Trametinib
- DRUG Dacarbazine
- DRUG Naporafenib
Study Locations (20)
Texas
- Texas Oncology- Austin Midtown - Austin
- Texas Oncology - Baylor Charles A. Sammons Cancer Center - Dallas
- The University of Texas MD Anderson Cancer Center - Houston
Florida
- Mayo Clinic - Florida - Jacksonville
- University of Miami Sylvester Cancer - Miami
Arizona
- Mayo Clinic - Arizona - Phoenix
California
- University of California, San Francisco - San Francisco
Colorado
- The Melanoma and Skin Care Institute - Englewood
Kansas
- University of Kansas Cancer Center - Kansas City
Louisiana
- Ochsner Clinic Foundation - Jefferson
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2024-04-29 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
What the registry record for NCT06346067 still lists
NCT06346067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Advanced or Metastatic NRAS-mutant Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Temozolomide is the first listed.
NCT06346067 names 20 study sites across 17 states, led by Texas, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06346067 about?
NCT06346067 is a clinical study titled "A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)". 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...
What is the current status of trial NCT06346067?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 78 participants. The study started on 2024-04-29. Estimated completion is 2028-12.
What conditions does trial NCT06346067 study?
This clinical trial studies the following conditions: Advanced or Metastatic NRAS-mutant Melanoma.
What interventions are being tested in trial NCT06346067?
The interventions under investigation include: Temozolomide (DRUG), Trametinib (DRUG), Dacarbazine (DRUG), Naporafenib (DRUG).
Who is sponsoring clinical trial NCT06346067?
This trial is sponsored by Erasca, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06346067 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06346067's enrollment target sits among peer trials
78 1770th of 2000 higher than 230 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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