A Pilot Study of Immunotherapy plus ADI-PEG 20 to Treat Advanced Uveal Melanoma

Full Title

Pilot Study Combining Arginine Depletion and Checkpoint Inhibition in Uveal Melanomas

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug ADI-PEG 20 in combination with nivolumab and ipilimumab immunotherapy in patients with advanced inoperable uveal or “uveal-like” melanoma.

ADI-PEG 20 is designed to kill tumor cells by breaking down a compound called arginine. Arginine plays an important role in making proteins; breaking down arginine may be a way to prevent cancer from growing and may make it easier for the immune system to detect uveal melanoma cells. It is given as an intramuscular (into the muscle) injection.

Ipilimumab and nivolumab are used together to treat melanoma of the skin. Both work by enhancing the ability of the immune system to find and destroy cancer cells. They are given intravenously (by vein).

Eligibility

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

  • Patients must have advanced inoperable uveal or uveal-like melanoma.
  • At least 3 weeks must pass between the completion of prior treatment and entry into the study.
  • Patients who have received prior nivolumab or ipilimumab cannot have severe or life-threatening side effects from this treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

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

Protocol

19-010

Phase

I

Co-Investigators