Full TitleFRV-004: A Randomized Multicenter Phase II Trial to Evaluate the Safety, Efficacy and Immunogenicity of Vaccination with Folate Receptor Alpha Peptides Admixed with GM-CSF as a Vaccine Adjuvant versus GM-CSF Alone in Patients with Platinum Sensitive Ovarian Cancer and a Response or Stable Disease to Platinum Therapy [RESTARTED FROM MED17-097]
Ovarian cancers are typically surgically removed and then treated with chemotherapy with platinum-containing drugs. While the cancer may initially shrink, it often comes back. The purpose of this study is to assess the safety and effectiveness of a cancer vaccine called TPIV200 in women with ovarian cancer that shrank or did not grow while on chemotherapy. Researchers want to see if TPIV200 can prevent or delay the return of ovarian cancer in these patients.
TPIV200 targets a protein called folate receptor alpha. This protein is rare in healthy tissue but is common in ovarian cancer tissue. The vaccine is made from protein pieces found on ovarian cancer cells. The protein pieces are mixed with an “adjuvant” called granulocyte-macrophage colony-stimulating factor (GM-CSF). In this study, patients will be randomly assigned to receive TPIV200 plus GM-CSF or GM-CSF alone. Both treatments are given by injection.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have ovarian, primary peritoneal, or fallopian tube cancer that was surgically removed and shrank or stopped growing after initial platinum-containing chemotherapy.
- Patients must receive their first dose of the study treatment within one year of finishing their initial platinum-containing chemotherapy.
- 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 women age 18 and older.
For more information and to inquire about eligibility for this study, please contact Dr. Roisin O’Cearbhaill at 646-888-4227.