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A single-arm, phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor: Korean Gynecologic Oncology Group (KGOG 3056)/NIRVANA-R trial

 Junsik Park  ;  Myong Cheol Lim  ;  Jae-Kwan Lee  ;  Dae Hoon Jeong  ;  Se Ik Kim  ;  Min Chul Choi  ;  Byoung-Gie Kim  ;  Jung-Yun Lee 
 JOURNAL OF GYNECOLOGIC ONCOLOGY, Vol.33(2) : e12, 2022-03 
Journal Title
Issue Date
Antineoplastic Combined Chemotherapy Protocols* / adverse effects ; Bevacizumab / therapeutic use ; Carcinoma, Ovarian Epithelial / drug therapy ; Female ; Humans ; Indazoles ; Neoplasm Recurrence, Local / chemically induced ; Neoplasm Recurrence, Local / drug therapy ; Ovarian Neoplasms* / drug therapy ; Ovarian Neoplasms* / pathology ; Piperidines ; Platinum / therapeutic use ; Poly(ADP-ribose) Polymerase Inhibitors / therapeutic use ; Republic of Korea
Bevacizumab ; Ovarian Neoplasms ; Poly(ADP-ribose) Polymerase Inhibitors ; Recurrence ; Retreatment
Background: Given the expanding clinical use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPis), there is a significant need for optimal strategies with which to treat patients whose cancer progresses while using a PARPi. However, the treatment consensus after PARPi has not been established. The aim of the Korean Gynecologic Oncology Group (KGOG) 3056/NIRVANA-R trial is to investigate the efficacy of niraparib in combination with bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARPi.

Methods: The KGOG 3056/NIRVANA-R is a multi-centre, investigator-initiated, single-arm, phase II trial of patients with platinum-sensitive recurrent ovarian cancer recruited from seven KGOG sites. This study included patients with platinum-sensitive recurrent epithelial ovarian cancer who received at least 2 previous courses of platinum-containing therapy and had been treated with a PARPi. Mucinous histology type was excluded. Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study. Forty-four patients will be recruited. All enrolled patients are treated with niraparib and bevacizumab for maintenance therapy until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint of the study is 6-month progression-free survival rate. Accrual is expected to be completed in 2022, followed by presentation of results in 2023.

Trial registration: ClinicalTrials.gov Identifier: NCT04734665.
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1. College of Medicine (의과대학) > BioMedical Science Institute (의생명과학부) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Park, Junsik(박준식)
Lee, Jung-Yun(이정윤) ORCID logo https://orcid.org/0000-0001-7948-1350
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