A Phase I Study of a Targeted Cancer Vaccine (Galinpepimut-S) Combined with Nivolumab Immunotherapy in Patients with Persistent Pleural Mesothelioma

Share
Print

Full Title

Combining a WT1 Cancer Vaccine (Galinpepimut-S) with Checkpoint Inhibition (Nivolumab) in Patients with WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study

Purpose

The purpose of this study is to assess the safety and effects of a cancer vaccine given with nivolumab immunotherapy in patients with pleural mesothelioma that continues to grow despite prior treatment. The vaccine is called galinpepimut-S and targets a protein called WT1, which is found on the surface of mesothelioma cells. It is mixed with a substance called montanide, which boosts the immune response.

Nivolumab inhibits a protein that normally puts the brakes on the immune response, enhancing the power of the immune system to find and destroy cancer cells. It is used to treat several types of cancer; its use in this study is considered investigational. It is believed that giving nivolumab in combination with a cancer vaccine will further enhance the immune response. Galinpepimut-S is given as an injection and nivolumab 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 pleural mesothelioma that continues to grow despite a previous course of treatment with pemetrexed chemotherapy.
  • Patients may not have previously received immunotherapy with a drug like nivolumab.
  • 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 Marjorie Zauderer at 646-888-4656.

Protocol

17-654

Phase

I

Investigator

Co-Investigators

Diseases