Study on Naporafenib and Trametinib for Patients with NRAS-mutant Melanoma (SEACRAFT-2)

Sponsor: Erasca, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06346067

Provider View

This clinical trial is testing a new combination of drugs, naporafenib and trametinib, to see if they can help patients with NRAS-mutant melanoma live longer without the cancer getting worse. The study will compare this combination to other standard treatments chosen by doctors.

Patient Parameters

Program Overview

The study aims to find the best dose of naporafenib combined with trametinib for treating patients with NRAS-mutant melanoma, a type of skin cancer that cannot be removed by surgery or has spread to other parts of the body. In the second stage, the study will compare how well patients do on this combination treatment versus other standard treatments like dacarbazine, temozolomide, or trametinib alone. Researchers will look at how long patients live without the cancer getting worse and their overall survival.

Description

SEACRAFT-2 is a large, international study that will test the effectiveness and safety of a new drug combination, naporafenib and trametinib, for patients with NRAS-mutant melanoma. This type of melanoma cannot be surgically removed or has spread to other areas. The study is divided into two parts: the first part will determine the best dose of the drug combination, and the second part will compare this combination to other treatments chosen by doctors, such as dacarbazine, temozolomide, or trametinib alone. The study will include about 470 patients who have already tried other treatments but need new options. Participants will be randomly assigned to receive either the new drug combination or one of the standard treatments. The study will monitor how long patients live without their cancer worsening and their overall survival.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide written consent to participate.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of melanoma that cannot be surgically removed or has spread.
  • Must have an NRAS mutation confirmed by a lab test.
  • Must have tumor tissue available for additional testing.
  • Must have previously received treatment with an anti-PD-1/L1 drug and shown disease progression during or shortly after treatment.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have at least one measurable tumor.
  • Must be able to swallow pills.

Exclusion Criteria

  • Cannot have uveal or mucosal melanoma.
  • Cannot have previously been treated with drugs targeting ERK, MEK, RAF, or RAS.
  • Cannot have digestive issues that affect drug absorption.
  • Cannot have a history of certain eye conditions like retinal vein occlusion.
  • Cannot have a heart function below 50%.
  • Cannot have unstable brain metastases.
  • Cannot be taking herbal medicines that affect the liver and cannot be stopped.
  • Cannot be pregnant, breastfeeding, or planning to have children during the study.

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