OncoMatch/Clinical Trials/NCT05460000
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
Is NCT05460000 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including 3 cycles chemotherapy instead of 6 cycles chemotherapy and 6 cycles chemotherapy for ovarian cancer.
Treatment: 3 cycles chemotherapy instead of 6 cycles chemotherapy · 6 cycles chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Allowed: BRCA1 pathogenic mutation
HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score >83 independent of BRCA status
Allowed: BRCA2 pathogenic mutation
HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score >83 independent of BRCA status
Disease stage
Required: Stage FIGO STAGE III, FIGO STAGE IV (FIGO)
Grade: high-grade
FIGO Stage III-IV high-grade ovarian cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: primary surgery — first line
Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively
Cannot have received: interval debulking
Has undergone interval debulking of the tumor
Cannot have received: any anti-cancer therapy for ovarian cancer other than primary surgery
Has received any anti-cancer therapy for ovarian cancer other than primary surgery
Cannot have received: PARP inhibitor
Has received prior treatment with a PARP inhibitor or has participated in a trial where any treatment arm included the administration of a PARP inhibitor
Lab requirements
Blood counts
Hemoglobin ≥ 10.0 g/dL independent of transfusion ≤ 14 days prior to screening; ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L
Kidney function
Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance > 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x institutional ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome; ASAT/SGOT and ALAT/SGPT ≤ 2.5 x ULN
Patients must have normal organ and bone marrow function: Hemoglobin ≥ 10.0 g/dL... Platelet count ≥ 100 x 10^9/L... Total bilirubin ≤ 1.5 x institutional ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome; ASAT/SGOT and ALAT/SGPT ≤ 2.5 x ULN; Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance > 30 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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