Georgia's Online Cancer Information Center

Find A Clinical Trial

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Status
Closed
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT03522246
Protocol IDs
CO-338-087/GOG-3020/ENGOT-ov45 (primary)
NCI-2018-01248
Study Sponsor
zr Pharma & GmbH

Summary

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm
study evaluating rucaparib and nivolumab as maintenance treatment following response to
front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will
be analyzed based on homologous recombination (HR) status of tumor samples.

Eligibility

  1. Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  2. Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
  3. Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
  4. Sufficient tumor tissue for planned analysis
  5. ECOG performance status of 0 or 1
  6. Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent

Treatment Sites in Georgia

Atlanta Gynecologic Oncology


980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342
404-303-3355
www.geraldfeuer.com

Doctors:

Gerald A. Feuer MD

Georgia Gynecologic Oncology


980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342
404-303-3355
www.ggo-atl.com/

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Study Coordinator:
Jen Cuvo
404-236-8304

Doctors:

Gerald A. Feuer MD
Guilherme Cantuaria MD
Meaghan Tenney MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.