A Phase II Study of Dacarbazine with and without Selumetinib to Treat Metastatic Uveal Melanoma

Protocol
14-033
Full Title
A Randomized, Double-Blind Study to Assess the Efficacy of Selumetinib (AZD6244, Hyd-Sulfate) in Combination with Dacarbazine Compared with Placebo in Combination with Dacarbazine as First Systemic Therapy in Patients with Metastatic Uveal Melanoma (SUMIT)
Phase
II
Purpose

Uveal melanoma is a cancer of the eye. When it has spread to other parts of the body, it is typically treated with dacarbazine, but the cancer may persist or come back.

In this study, researchers want to see if adding the drug selumetinib to dacarbazine treatment is more effective than dacarbazine alone for patients with metastatic uveal melanoma. Selumetinib inhibits a protein called MEK, which is overactive in most uveal melanomas.

Patients in this study will be randomly assigned to receive dacarbazine plus selumetinib (three-quarters of the patients) or dacarbazine plus placebo (one-quarter of patients). Selumetinib is taken orally (by mouth), while dacarbazine is given intravenously (by vein). Patients whose cancers continue to grow despite dacarbazine/placebo will be able to switch to dacarbazine/selumetinib.

Eligibility

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

  • Patients must have metastatic uveal melanoma that has not yet been treated with a systemic therapy (like dacarbazine or other chemotherapy).
  • At least 4 weeks must have passed since completion of any prior radiation therapy or major surgery 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. Michael Postow at 646-888-4589.

Disease(s)
Melanoma: Melanoma of the Eye
Locations
Related Diseases