A Phase I Study of Galinpepimut-S and Pembrolizumab Immunotherapy in Women with Advanced Ovarian Cancer

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Full Title

A Phase 1/2 Study of Galinpepimut-S in Combination with Pembrolizumab (MK-3475) in Patients with Selected Advanced Cancers

Purpose

This study will assess the safety of the investigational drug galinpepimut-S (GPS) combined with pembrolizumab immunotherapy and find out what effects, if any, this combination treatment has on metastatic ovarian cancer. GPS stimulates the immune system to produce specialized immune cells that target the WT1 protein produced by some cancer cells. Before GPS is given, it is mixed with Montanide, which boosts the immune system’s response to WT1 and makes GPS more effective.

Pembrolizumab enhances the ability of the immune system to recognize and destroy cancer cells. GPS may help pembrolizumab work better against cancer while decreasing the risk that the immune system will attack healthy cells. GPS is given as an injection and pembrolizumab 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 ovarian cancer that makes the WT1 protein and continues to grow despite one or two prior regimens of therapy.
  • 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 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 women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roisin O’Cearbhaill at 646-888-4227.

Protocol

19-435

Phase

I/II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators