Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

Phase 2 Unknown 44 enrolled Yonsei University Takeda · collab

NaSingle-groupOpen-labelTreatment

Summary

This study is phase II, open label, clinical trial to determine the efficacy of Niraparib re-treatment with Bevacizumab of assessment progression-free survival(6 months PFS rate) with platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor.

Timeline

Start: 2021-07-05
Primary completion: 2023-03-31
Completion: 2024-03-31

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary endpoint of the study is 6-month progression-free survival rate. PMID 34910393 ↗

Publications

Park J, Lim MC, Lee JK, Jeong DH, Kim SI, Choi MC, Kim BG, Lee JY. 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. J Gynecol Oncol. 2022 Mar;33(2):e12. doi: 10.3802/jgo.2022.33.e12. Epub 2021 Dec 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	—
Subject	Niraparib	Small molecule	200 mg	—
Subject	Niraparib	Small molecule	300 mg	—

Indications

No indication recorded.