August 13 2021
NRG-GY023: A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination with Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women with Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab
NRG-GY023 is an NRG Oncology clinical trial that recently opened to patient enrollment for women with platinum-resistant, recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer who have been previously treated with bevacizumab. The trial will be testing different combinations of the drugs durvalumab (MEDI4736), olaparib, and cediranib to see if any of the drug combinations improve progression-free survival (PFS) when compared to the usual treatment of non-platinum chemotherapy for this patient population.
Women enrolled in the trial will be stratified by their prior PARP inhibitor or prior immune checkpoint inhibitor exposure. Following stratification, women will be enrolled into one of four potential treatment arms; (1) the standard of care non-platinum single agent chemotherapy, (2) treatment combination consisting of durvalumab (MEDI4736), olaparib, and cediranib, (3) a treatment combination consisting of durvalumab (MEDI4736) and cediranib; or (4) a treatment consisting of olaparib and cediranib. Trial participants will be monitored for disease progression.
“In the United States, ovarian cancer is the deadliest of the gynecologic malignancies and most women present with epithelial ovarian cancer at an advanced stage with a high risk of recurrence. Additionally, platinum resistance is associated with a poor prognosis in these women, especially those who have been treated previously with bevacizumab or PARP inhibitors” stated Jung-Min Lee, MD, of the National Cancer Institute (NCI) Center for Cancer Research and the Principal Investigator of the NRG-GY023 study.
The primary focus of NRG-GY023 is to determine if the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib improve PFS in this patient population when compared to the standard of care. Additionally, researchers will assess the drug combinations to ascertain if they improve overall response rate or overall survival for patients.
“It is crucial that researchers find a novel treatment for recurrent ovarian cancer as there are currently no effective therapeutic options available for this population. NRG-GY023 sets the stage to find clinical benefit from other agents to meet the unmet need for women with this diagnosis,” Lee added.
Learn more about this trial on ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website.