HCC 18-087: Recurrent Ovarian Cancer Study

STUDY BASICS

Do you have ovarian cancer that has recurred following treatment? If so, you may be eligible to participate in a research study to help find out if adding investigational drugs called pembrolizumab (Keytruda®) and rintatolimod (Ampligen®) to routine treatment with intraperitoneal cisplatin has an effect on recurrent ovarian cancer.

STUDY PURPOSE

Women with ovarian cancer typically have surgery and receive chemotherapy, but the disease sometimes comes back and requires additional treatment. Ovarian cancer that comes back (called recurrent ovarian cancer) is often treated with intraperitoneal chemotherapy—a treatment that involves injecting chemotherapy directly into the abdomen through a thin tube. The purpose of this study is to find out if adding the investigational drugs pembrolizumab (brand name Keytruda®) and rintatolimod (brand name Ampligen®) to routine treatment with an intraperitoneal chemotherapy called cisplatin has an effect on recurrent ovarian cancer.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Diagnosed with recurrent ovarian cancer (ovarian cancer that has returned after treatment)

WHAT PARTICIPANTS CAN EXPECT

Participation involves an initial screening period, followed by about six months of treatment, and about three years of follow up. Participants in the study will have a tumor biopsy, peritoneal port placement, blood draws, and other procedures as needed. All participants will be treated with intraperitoneal cisplatin and rintatolimod and an infusion of pembrolizumab every three weeks for about six months. Cisplatin will be given on Mondays; pembrolizumab and rintatolimod will be given on Tuesdays.