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

JUNG-YUN LEE Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, South Korea info_outline JUNG-YUN LEE, Junsik Park, Jae Kwan Lee, Dae Hoon Jeong, Se Ik Kim, Min Chul Choi, Byoung-Gie Kim, Myong Cheol Lim, Jeong-Yeol Park

Authors JUNG-YUN LEE Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, South Korea info_outline JUNG-YUN LEE, Junsik Park, Jae Kwan Lee, Dae Hoon Jeong, Se Ik Kim, Min Chul Choi, Byoung-Gie Kim, Myong Cheol Lim, Jeong-Yeol Park Organizations Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, South Korea, Yonsei University, Seoul, South Korea, Korea University Guro Hospital, Seoul, South Korea, Inje University Busan Paik Hospital, Busan, South Korea, Seoul National University College of Medicine, Seoul, South Korea, CHA Bundang Medical Center, Seongnam-si, South Korea, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, National Cancer Center, Goyang-Si, Gyeonggi-Do, South Korea, Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea Abstract Disclosures Research Funding Pharmaceutical/Biotech Company 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 and 4 of planned 44 patients have been enrolled. Clinical trial information: NCT04734665.