Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab

Trial ID #	NCT03326193; OVARIO
Phase	II
Drug Class	DNA Damage Repair Pathway Inhibitors: PARP
Drug Name	Niraparib
Alternate Drug Names	MK4827, Zejula
Drugs in Trial	Carboplatin, Paclitaxel, Bevacizumab, Niraparib
Eligible Participant	Newly diagnosed high grade serous or endometrioid stage IIIb/IV ovarian cancer with CR or PR after first-line therapy
Patients Enrolled	105; 79% stage III, 63% w/ neoadjuvant chemotherapy
Therapy Setting	Maintenance
Study Design	Open-Label, Non-randomized
Endpoints	PFS, evaluated per RECIST
Efficacy	PFS: 19.6 months PFS (BRCA MUT): NR PFS (HRD): 28.3 months PFS (HRP): 14.2 months PFS (6 months): 90% PFS (12 months): 75% PFS (18 months): 62% PFS (24 months): 53%
Conclusion	Niraparib+bevacizumab maintenance treatment does not appear to cause cumulative toxicities and shows promising PFS
Reference	Hardesty MM et al. OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. Gynecol Oncol (2022) 166(2):219-229 https://pubmed.ncbi.nlm.nih.gov/35690498/