Status: Recruiting
A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy
Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.
Participants needed: 640
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: North Eastern German Society of Gynaecological OncologyUpdated: Feb 12, 2026Locations: 47
Eligibility criteria
Written informed consent and obtained from the subject prior to performing any p... [+16]
Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e.,... [+28]