A Phase I Study of Immunotherapy with the WT1 Vaccine and Nivolumab in Women with Recurrent Ovarian Cancer

Full Title

A Phase I Study of Concomitant WT1 Analog Peptide Vaccine with Montanide and GM-CSF in Combination with Nivolumab in Patients with Recurrent Ovarian Cancer who are in Second or Greater Remission

Purpose

Researchers in this study are evaluating the immune response following combination treatment with the investigational WT1 vaccine plus the drug nivolumab in women with ovarian cancer that is in second or greater remission. This treatment is a form of immunotherapy.

WT1 is a protein involved in normal development, but can fuel cancer growth when it is abnormal. WT1 is often overexpressed in ovarian cancer cells. The WT1 vaccine is designed to stimulate a patient's immune system to kill any cancer cells remaining in the body after treatment. Patients will also receive Montanide and GM-CSF (other drugs) to boost the immune response triggered by the vaccine.

Nivolumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Nivolumab is approved for treating several types of cancer. Its use in this study is considered investigational. It is hoped that the immune response following both the vaccine and nivolumab is greater than either treatment alone.

The WT1 vaccine is given as a subcutaneous (under the skin) injection, while 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 WT1-positive ovarian, fallopian tube, or primary peritoneal cancer that is in second or greater remission.
  • Patients must start vaccine therapy within 4 months of completing chemotherapy.
  • 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

15-247

Phase

I

Investigator

Co-Investigators