A Phase I/II Study of IMCgp100 Immunotherapy in Patients with Advanced Uveal Melanoma

Full Title

IMCgp100-102: A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 using the Intra-patient Escalation Dosing Regimen in Patients with Advanced Uveal Melanoma

Purpose

Uveal melanoma is a cancer of the eye. In this study, researchers will assess increasing doses of the investigational immunotherapy drug IMCgp100 in patients with advanced uveal melanoma. Patients will receive a lower dose on the first two weeks, and in the third week and beyond, they will receive a higher dose.

Tumors are capable of inactivating immune cells called killer T cells and often evade detection by the immune system. IMCgp100 is an investigational drug that can refocus a T cell against the gp100 protein in uveal melanoma cells. It is 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 metastatic uveal melanoma that persists despite one or two prior regimens of therapy.
  • Patients will be tested for a certain type of protein on their immune cells called HLA-A 02:01, and only those with that protein can participate in the treatment part of the study.
  • Patients should recover from the serious side effects of previous therapies before entering 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 about this study and to inquire about eligibility, please contact Dr. Alexander Shoushtari at 646-888-4161.

Protocol

18-241

Phase

I

Co-Investigators