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Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

NCT05183984 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-04-13

No results posted yet for this study

Summary

Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.

Conditions

Interventions

DRUG

Chemotherapy

Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period

DRUG

Bevacizumab-Awwb

MVASI (bevacizumab biosimilar) will be administrated by intravenous infusion at the second chemotherapy cycle for 5 cycles. the administration will continue during maintenance phase. Total bevacizumab duration therapy is 15 months.

DRUG

Niraparib

niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years.

Sponsors & Collaborators

  • ARCAGY/ GINECO GROUP

    lead OTHER

Principal Investigators

  • Gilles FREYER, Pr · HCL - Centre Hospitalier Lyon Sud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2027-02-28
Completion
2032-02-01

Countries

  • France
  • Italy
  • Japan
  • Singapore
  • South Korea
  • Spain

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 NCT05183984 on ClinicalTrials.gov