Ovarian CarcinomaOVNI-BNCT06827353
Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency
An observational study of Ovarian Carcinoma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- maintenance therapy with bevacizumab and maintenance therapy with niraparib
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Disease progression after chemotherapy
- Presence of a BRCA mutation (somatic or germline)
- Positive HRD score
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sabrina Nicolas contact
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes, Occitanie, 30029
Sarah Kabani, +33466684175, sarah.kabani@chu-nimes.fr
Soufyan Annakib, M.D.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Ovarian Carcinoma
- Being tested
- maintenance therapy with bevacizumab, maintenance therapy with niraparib
- Keywords
- Ovarian cancer, Epithelial carcinoma, BRCA wild type, HRP, bevacizumab, niraparib, maintenance therapy, survival
- Medical subject headings
- Ovarian Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance therapy with bevacizumabDrug
Also called bevacizumab, niraparib
Maintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received bevacizumab after chemotherapy.
maintenance therapy with niraparibDrug
Maintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received niraparib after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| niraparib | Patients who received niraparib as maintenance therapy Receives: Drug: maintenance therapy with niraparib | |
| bevacizumab | Patients who received bevacizumab as maintenance therapy Receives: Drug: maintenance therapy with bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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 outcomes (1)
Overall survival of the two groups
Overall survival (OS) defined as time from initiation of maintenance therapy with bevacizumab monotherapy or niraparib to date of death from any cause
Measured: From date of maintenance therapy start until the date of death from any cause, assessed up to 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Oct 2020
- Primary completion31 May 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- soufyan annakib, M.D., Principal investigatorFrédéric Fiteni, M.D., Ph.D., Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827353
- Sponsor's protocol ID
- 24.10.24
- Acronym
- OVNI-B
- Status last verified
- Feb 2025
- First submitted
- 5 Nov 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available only on demande. Available data will be only those used for study results publication.
Publications
Hannaway N, Kassaris S, Davies JM, Smrke A, Tinker A, Drew Y. Using chemotherapy response by KELIM score to predict response to first line maintenance PARP inhibitor therapy in non-BRCA mutant/homologous recombination deficiency (HRD) unknown high grade serous ovarian cancer (HGSOC). J Clin Oncol. 1 juin 2023;41(16_suppl):e17547-e17547.
Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, Huang H, Mannel RS, Homesley HD, Fowler J, Greer BE, Boente M, Birrer MJ, Liang SX; Gynecologic Oncology Group. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2473-83. doi: 10.1056/NEJMoa1104390.
PubMed 22204724Gonzalez-Martin A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Perez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.
PubMed 31562799Gonzalez-Martin A, Harter P, Leary A, Lorusso D, Miller RE, Pothuri B, Ray-Coquard I, Tan DSP, Bellet E, Oaknin A, Ledermann JA; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Oct;34(10):833-848. doi: 10.1016/j.annonc.2023.07.011. Epub 2023 Aug 17. No abstract available.
PubMed 37597580Defossez G, le Guyader-Peyrou S, Uhry Z. Estimations nationales de l'incidence et de la mortalité par cancer en France métropolitaine entre 1990 et 2018. Saint-Maurice (Fra): Santé publique France; 2019.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06827353
- Acronym / sponsor ID
- OVNI-B / 24.10.24
- Conditions
- Ovarian Carcinoma
- Keywords
- Ovarian cancer, Epithelial carcinoma, BRCA wild type, HRP, bevacizumab, niraparib, maintenance therapy, survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| niraparib | – | Drug: maintenance therapy with niraparibPatients who received niraparib as maintenance therapy |
| bevacizumab | – | Drug: maintenance therapy with bevacizumabPatients who received bevacizumab as maintenance therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Disease progression after chemotherapy
- Presence of a BRCA mutation (somatic or germline)
- Positive HRD score
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maintenance therapy with bevacizumabAlso: bevacizumab, niraparibMaintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received bevacizumab after chemotherapy. | Drug | bevacizumab |
| maintenance therapy with niraparibMaintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received niraparib after chemotherapy. | Drug | niraparib |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- BackgroundHannaway N, Kassaris S, Davies JM, Smrke A, Tinker A, Drew Y. Using chemotherapy response by KELIM score to predict response to first line maintenance PARP inhibitor therapy in non-BRCA mutant/homologous recombination deficiency (HRD) unknown high grade serous ovarian cancer (HGSOC). J Clin Oncol. 1 juin 2023;41(16_suppl):e17547-e17547.
- Background: PubMed 22204724Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, Huang H, Mannel RS, Homesley HD, Fowler J, Greer BE, Boente M, Birrer MJ, Liang SX; Gynecologic Oncology Group. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2473-83. doi: 10.1056/NEJMoa1104390.
- Background: PubMed 31562799Gonzalez-Martin A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Perez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.
- Background: PubMed 37597580Gonzalez-Martin A, Harter P, Leary A, Lorusso D, Miller RE, Pothuri B, Ray-Coquard I, Tan DSP, Bellet E, Oaknin A, Ledermann JA; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Oct;34(10):833-848. doi: 10.1016/j.annonc.2023.07.011. Epub 2023 Aug 17. No abstract available.
- BackgroundDefossez G, le Guyader-Peyrou S, Uhry Z. Estimations nationales de l'incidence et de la mortalité par cancer en France métropolitaine entre 1990 et 2018. Saint-Maurice (Fra): Santé publique France; 2019.
- Individual participant dataSharing planned: Yes. Data will be available only on demande. Available data will be only those used for study results publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabrina Nicolas contact
soufyan annakib, M.D. principal investigator
Frédéric Fiteni, M.D., Ph.D. principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Carcinoma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soufyan Annakib, M.D. (+33466683301, soufyan.annakib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827353, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.