A Phase II Study of Ensartinib in Patients with Advanced Melanoma and ALK Protein Abnormalities

Full Title

IIT: A Phase 2 Study of the ALK Inhibitor Ensartinib for Patients with Melanomas Harboring ALK Alterations or Aberrant ALK Expression

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug ensartinib in patients with melanoma that has continued to grow despite medical treatment and which contain an altered form of the ALK protein. Ensartinib works by blocking abnormal ALK, which drives the growth of some melanomas. Ensartinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced melanoma that has continued to grow despite immunotherapy. Patients with BRAF-positive cancers must also have previously received a BRAF inhibitor (such as vemurafenib).
  • Patients’ tumors must contain abnormal ALK protein expression or an ALK genetic fusion. Patients whose tumors have not been tested for abnormal ALK expression are eligible to sign up for the screening part of the study.
  • At least 2-3 weeks must pass between completion of prior therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Shoushtari at 646-888-4161.

Protocol

17-471

Phase

II

Co-Investigators

Diseases