A Phase I Study of the NY-ESO-1 Vaccine plus Ipilimumab in Patients with Inoperable or Metastatic Melanoma

Protocol
12-253
Full Title
Phase I Study of NY-ESO-1 Vaccine in Combination with Ipilimumab in Patients with Unresectable or Metastatic Melanoma, For Whom Treatment with Ipilimumab is Indicated
Phase
I
Purpose

The purpose of this study is to assess a combination of immunotherapies against advanced melanoma: the investigational NY-ESO-1 vaccine and the FDA-approved drug ipilimumab. NY-ESO-1 is a protein found on some melanomas. The vaccine that targets this protein is designed to stimulate an immune response against melanoma.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism. An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy remaining cancer cells.

The goal of this study is to assess the safety of and immune response to the NY-ESO-1 vaccine when given to patients in combination with ipilimumab, and to assess the preliminary effectiveness of this therapy.

Eligibility

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

  • Patients must have inoperable or metastatic melanoma and be candidates for ipilimumab therapy.
  • At least 3 weeks must have passed since any major surgery and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to 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
Locations
Related Diseases