Niraparib Versus Bevacizumab As Maintenance Therapy in Patients with De Novo Ovarian Cancer Without Homologous Recombination Deficiency (OVNI-B)

February 10, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

Retrospective Study to Evaluate Niraparib Versus Bevacizumab As Maintenance Therapy After First-line Treatment with Platinum-based Chemotherapy in Patients with De Novo Ovarian Cancer Without Homologous Recombination Deficiency

Background: High-grade serous epithelial ovarian cancer is a disease with a poor prognosis in the advanced stages (stages III and IV). For patients with no biomolecular abnormalities, there are two maintenance treatments available after first-line chemotherapy: bevacizumab or niraparib. There is no prospective or strong retrospective study comparing these two therapies.

Hypothesis: Patients receiving bevacizumab are different from those receiving niraparib.

Objective: To compare the progression-free survival (PFS) of patients with high-grade stage III and IV ovarian carcinoma who received chemotherapy with those who received maintenance treatment with bevacizumab and those who received niraparib.

Method: Retrospective, multicenter study based on data collected from the patient's medical record. Eligible patients are all patients diagnosed with de novo high-grade serous epithelial ovarian carcinoma who have received first-line platinum-based chemotherapy followed by maintenance treatment with bevacizumab or niraparib. All eligible patients will be included. Patients with a BRCA mutation and/or a positive HRD score will be excluded. Data will be collected using an electronic CRF. The inclusion period is from October 2020 to December 2023.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction The incidence of ovarian cancer in France is estimated at over 5,100 cases/year in 2018. The most common histological form is high-grade serous epithelial carcinoma, which accounts for around 70% of ovarian cancers. Mortality is estimated at over 3,400 cases per year. The management of newly-diagnosed patients is based on multimodal treatment with maximal cytoreductive surgery, platinum-based chemotherapy and targeted therapy. For patients with advanced disease (stage III or IV), peri-operative or adjuvant chemotherapy with carboplatin combined with paclitaxel is the standard of treatment. At the end of this treatment, patients benefit from maintenance therapy, which may differ according to their biomolecular characteristics. For patients with a BRCA gene mutation or a high HRD score, the standard treatment is a combination of poly-ADP-ribose-polymerase inhibitor (iPARP) and an anti-VEGF antiangiogenic, bevacizumab.

On the other hand, for patients with no BRCA mutation or with a low HRD score (known as HRP), there are two treatment standards. They can be treated with an iPARP, niraparib. Indeed, the phase III PRIMA trial, which evaluated survival in patients with advanced ovarian cancer regardless of BRCA or HRD status, showed an improvement in progression-free survival (PFS) on an intention-to-treat basis. However, in the population of patients without BRCA and HRP mutations, PFS was 8.1 months in the niraparib group versus 5.4 months in the placebo group. The difference was statistically significant, with a hazard ratio of 0.68 (95% confidence interval 0.49-0.94). Overall survival data were not yet mature in 2023 in the most recent publication.

These same patients may also benefit from maintenance treatment with bevacizumab. A benefit in terms of PFS and OS has been demonstrated for populations at high risk of relapse (stage IV, or non-operable stage III or non-maximal surgery) in the ICON7 phase III study. In the GOG-0218 phase III study, bevacizumab was only shown to benefit progression-free survival.

Thus, both therapeutic strategies can be proposed as maintenance treatment after first-line chemotherapy for patients with advanced high-grade epithelial ovarian carcinoma in the non-mutated BRCA and HRP subpopulation. The data available to help choose between the two molecules are limited. The safety profile of each molecule and the contraindications may help in the choice. In their absence, there are no validated criteria in the scientific literature. The KELIM score (CA-125 ELIMination of Rate Constant K) can be used to predict iPARP efficacy. However, it has not been validated in this indication, since it was originally developed to predict chemosensitivity in these patients. Finally, there are no studies directly comparing the efficacy of bevacizumab with niraparib in this population.

Real-life data are therefore needed to understand and analyze prescribing practices, in order to identify avenues to aid therapeutic choice. Our study therefore aims to describe a population of patients with advanced high-grade epithelial ovarian carcinoma treated with maintenance bevacizumab or niraparib after platinum-based chemotherapy.

Study aim

Main objective:

To compare the progression-free survival (PFS) of patients with high-grade stage III and IV epithelial ovarian carcinoma who received chemotherapy between those who received maintenance treatment with bevacizumab and those who received niraparib.

Secondary objectives A. To describe the OS of the two groups. B. To compare the clinical, biological and sociodemographic characteristics of the two groups.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Occitanie
      • Nîmes, Occitanie, France, 30029
        • Recruiting
        • CHU de Nîmes
        • Contact:
        • Contact:
          • Soufyan Annakib, M.D.
        • Contact:
          • Frederic Fiteni, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Identification of eligible patients in each center will be selected using the following criteria:

  • Ovarian cancer
  • Stage III or stage IV
  • Treatment initial surgery followed by chemotherapy or initial chemotherapy
  • Maintenance treatment with targeted therapy Then, inclusion and exclusion criterias will be applied . An electronic CRF (RedCap) will be used for data records.

Description

Inclusion Criteria:

  • De novo diagnosis of stage III or IV high-grade epithelial ovarian carcinoma, not candidate for primary tumor reduction surgery.
  • De novo diagnosis of high-grade epithelial ovarian carcinoma benefiting from a combination of chemotherapy and maximal cytoreduction surgery
  • All patients who have received maintenance treatment after chemotherapy with bevacizumab or niraparib monotherapy.

Exclusion Criteria:

  • Disease progression after chemotherapy
  • Presence of a BRCA mutation (somatic or germline)
  • Positive HRD score

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
niraparib
Patients who received niraparib as maintenance therapy
Drug: maintenance therapy with niraparib
Maintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received niraparib after chemotherapy.
bevacizumab
Patients who received bevacizumab as maintenance therapy
Drug: maintenance therapy with bevacizumab
Maintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received bevacizumab after chemotherapy.
Other Names:
  • bevacizumab
  • niraparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival of patients with high-grade stage III and IV epithelial ovarian carcinoma who received chemotherapy between those who received maintenance treatment with bevacizumab and those who received niraparib.
Time Frame: From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months
Progression-free survival (PFS) defined as the time from initiation of maintenance therapy with bevacizumab monotherapy or niraparib to the date of disease progression or death from any cause. Disease progression is defined as cessation of maintenance therapy due to radiological and/or biological progression at the discretion of the oncologist managing the patient.
From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival of the two groups
Time Frame: From date of maintenance therapy start until the date of death from any cause, assessed up to 38 months
Overall survival (OS) defined as time from initiation of maintenance therapy with bevacizumab monotherapy or niraparib to date of death from any cause
From date of maintenance therapy start until the date of death from any cause, assessed up to 38 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CA-125 ELIMination rate constant K (KELIM) score between groups
Time Frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 38months
If CA-125 ELIMination rate constant K (KELIM) score result is less than value 1 patients will be classified as unfavorable risk. If KELIM score result equal or more than 1, patients will be classified as favorable risk.
From date of randomization until the date of death from any cause, whichever came first, assessed up to 38months
Radiological response
Time Frame: From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months
Radiologic response according on CT-scan after chemotherapy, at maintenance therapy will be adressed using the Response Evaluation Criteria In Solid Tumours version 1.1 as fur categories : progression disease, stable disease, partial response disease and complete response disease
From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months
Comparrative performans status between two groups
Time Frame: From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months
Performance status Eastern Cooperative Oncology Group (PS ECOG) scalled from 0 to 5. Score 0 correspond to fully active, able to carry on all pre-disease performance without restriction. Score 5 correspond to Dead patient.
From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months
Quality of surgical resection
Time Frame: From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months
This issue will be addressed using the pathologist and the residual tumor (R) classification. R0 corresponds to resection for cure or complete remission. R1 to microscopic residual tumor, R2 to macroscopic residual tumor
From date of maintenance therapy start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 38 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: soufyan annakib, M.D.
  • Principal Investigator: Frédéric Fiteni, M.D., Ph.D., Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24.10.24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available only on demande. Available data will be only those used for study results publication.

IPD Sharing Time Frame

After results publication.

IPD Sharing Access Criteria

Only on demande.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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