Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

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

FieldValue
Enrollment Target 78 participants
Start Date 2024-04-29
Est. Completion 2028-12
Phase Phase 3
Erasca

8 total trials

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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02397668 · 78 participants · NA

    CorMatrix Cor TRICUSPID ECM Valve Replacement Study

  • NCT03321656 · 78 participants · Phase 2

    Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

  • NCT03687814 · 78 participants · NA

    Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation

  • NCT04018872 · 78 participants · Phase 2

    Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT06346067, the US trial registry maintained by the National Library of Medicine. NCT06346067 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.