Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency

NCT06827353 | Recruiting

• 1 other identifier: 24.10.24
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ovarian Carcinoma

Keywords

Ovarian cancer; Epithelial carcinoma; BRCA wild type; HRP; bevacizumab; niraparib; maintenance therapy; survival

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From date of maintenance therapy start until the date of death from any cause, assessed up to 38 months

Other Outcomes (4)

• CA-125 ELIMination rate constant K (KELIM) score between groups

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 38months

• Radiological response

  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

  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

Study Arms (2)

niraparib

Patients who received niraparib as maintenance therapy

Drug: maintenance therapy with niraparib

bevacizumab

Patients who received bevacizumab as maintenance therapy

Drug: maintenance therapy with bevacizumab

Interventions

maintenance therapy with bevacizumab DRUG

Maintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received bevacizumab after chemotherapy.

Also known as: bevacizumab, niraparib

bevacizumab

maintenance therapy with niraparib DRUG

Maintenance therapy after platine-based chemotherapy in non-mutated advanced ovarian cancer is unclear. Arm of patients that received niraparib after chemotherapy.

niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, Occitanie, 30029, France

RECRUITING

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  PMID: 22204724 BACKGROUND

• Gonzalez-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.

  PMID: 31562799 BACKGROUND

• Gonzalez-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.

  PMID: 37597580 BACKGROUND

• Defossez 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.

  BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma

Interventions

Maintenance; Bevacizumab; niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• soufyan annakib, M.D.

  PRINCIPAL INVESTIGATOR

• Frédéric Fiteni, M.D., Ph.D.

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soufyan Annakib, M.D.

CONTACT

+33466683301; soufyan.annakib@gmail.com

Sabrina Nicolas

CONTACT

sabrina.nicolas@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: February 14, 2025
• Study Start: October 1, 2020
• Primary Completion: May 31, 2025
• Study Completion: September 30, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After results publication.
• Access Criteria: Only on demande.

Locations

FR (1)