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Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer

NCT05009082 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 970

Last updated 2025-09-10

No results posted yet for this study

Summary

This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.

Conditions

Interventions

DRUG

Carboplatin

Area under curve (AUC) 5, intravenous, on day 1 every 3 weeks for 6 cycles

DRUG

Paclitaxel

175 mg/m², intravenous, on day 1 every 3 weeks for 6 cycles

DRUG

Bevacizumab

7.5 mg/kg or 15 mg/kg (according to local standard), intravenous, on day 1 every 3 weeks starting from cycle 2 in combination with chemotherapy and thereafter for up to 1 year starting from Cycle 7 Day 1

DRUG

Niraparib

200 or 300 mg capsules once daily for up to a total of 3 years starting from Cycle 7 Day 1

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • AGO Study Group

    lead OTHER

Principal Investigators

  • Philipp Harter, MD, PhD · KEM Essen | Evang. Kliniken Essen-Mitte gGmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2028-12-31
Completion
2031-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT05009082 on ClinicalTrials.gov