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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

NCT05460000 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-02-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

3 cycles chemotherapy instead of 6 cycles chemotherapy

We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.

DRUG

6 cycles chemotherapy

Standard chemotherapy as comparator

Sponsors & Collaborators

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    collaborator OTHER

  • North Eastern German Society of Gynaecological Oncology

    lead OTHER

Principal Investigators

  • Jalid Sehouli, Prof. Dr. med. · Lead coordinating investigator (LKP) according to AMG and representative of the sponsor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-11
Primary Completion
2032-10-01
Completion
2032-10-01
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Czechia
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05460000 on ClinicalTrials.gov