Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
Niraparib vs Niraparib in Combination With Bevacizumab in Patients With Carboplatinum-taxane Based Chemotherapy in Advanced Ovarian Cancer (A Multicentre Randomised Phase III Trial)
4 other identifiers
interventional
970
1 country
65
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
Started Sep 2022
Longer than P75 for phase_3 ovarian-cancer
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
September 10, 2025
September 1, 2025
6.2 years
August 2, 2021
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Defined as the time from randomization to first progressive disease (PD) or death, whichever occurs earlier. PD is based on investigators assessment using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier
Secondary Outcomes (7)
PFS according to tumor BRCA status
Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier
Overall Survival (OS)
at every visit during the trial up to 66 months after Last Patient In
Time to First Subsequent Therapy (TFST)
at every visit during the trial up to 66 months after Last Patient In
Second Progression (PFS 2)
at every visit during the trial up to 66 months after Last Patient In
Time to Second Subsequent Therapy (TSST)
at every visit during the trial up to 66 months after Last Patient In
- +2 more secondary outcomes
Study Arms (2)
Arm 1
ACTIVE COMPARATORChemotherapy followed by maintenance with niraparib
Arm 2
ACTIVE COMPARATORChemotherapy in combination with bevacizumab followed by maintenance with bevacizumab and niraparib
Interventions
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
200 or 300 mg capsules once daily for up to a total of 3 years starting from Cycle 7 Day 1
Eligibility Criteria
You may qualify if:
- Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the clinical trial requirements.
- Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO stage IIIA2 without nodal involvement) according to recent FIGO classification (= FIGO stage IIIB - IV according to FIGO 2009 classification).
- All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery.
- Patients must have available tumor samples to be sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of BRCA status prior to randomization for stratification.
- Patients must be able to commence systemic therapy within 8 weeks of cytoreductive surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- Estimated life expectancy \> 3 months.
- Adequate bone marrow function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2)
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L
- Platelets (PLT) ≥ 100 x 10\^9/L
- Hemoglobin (Hb) ≥ 9 g/dL (can be post-transfusion)
- Adequate coagulation parameters (within 28 days prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2)
- Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x institutional upper limit of normal (ULN).
- The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of anticoagulants for at least one week at the time of randomization.
- Adequate liver and kidney function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2)
- +10 more criteria
You may not qualify if:
- Non-epithelial tumor origin of the ovary.
- Ovarian tumors of low malignant potential (e.g. borderline tumors) and low grade tumors.
- Planned intraperitoneal cytotoxic chemotherapy.
- Malignancies other than ovarian cancer within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or stage I p53 wild type endometrial cancer).
- Prior systemic treatment for ovarian cancer.
- Prior treatment with Poly adenosine diphosphate ribose polymerase (PARP) inhibitor.
- Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).
- Prior randomization in this trial.
- Major surgery within 1 week of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted.
- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected spinal cord compression.
- Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab.
- Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to day 1, cycle 1.
- History or evidence of thrombotic or hemorrhagic disorders within 3 months prior to day 1, cycle 1.
- History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures.
- Pregnant or lactating women.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Klinikum St. Marien Amberg
Amberg, Germany
Klinikum Augsburg
Augsburg, Germany
Hochtaunus-Kliniken
Bad Homburg, Germany
Helios Klinikum Berlin-Buch
Berlin, Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany
Städt. Klinikum Brandenburg
Brandenburg, Germany
Klinikum Bremen Mitte
Bremen, Germany
Klinikum Chemnitz
Chemnitz, Germany
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, Germany
Klinikum Dortmund
Dortmund, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Florence-Nightingale-Krankenhaus Düsseldorf
Düsseldorf, Germany
Universitätsfrauenklinik Düsseldorf
Düsseldorf, Germany
KEM Essen | Evang. Kliniken Essen-Mitte gGmbH
Essen, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Klinikum Frankfurt Höchst
Frankfurt am Main, Germany
Universitätsklinikum Gießen
Giessen, Germany
Klinikum Gütersloh
Gütersloh, Germany
Universitätsklinikum Halle
Halle, Germany
Albertinen Krankenhaus
Hamburg, Germany
Mammazentrum HH am Krankenhaus Jerusalem
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Gynäkologisch-Onkologische Praxis am Pelikanplatz
Hanover, Germany
Universitätsklnikum Heidelberg
Heidelberg, Germany
Klinikum am Gesundbrunnen / SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany
Gyn.-onkolog. Gemeinschaftspraxis Hildesheim
Hildesheim, Germany
Universtitätsklinikum Jena
Jena, Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Germany
Klinikum Kassel
Kassel, Germany
Klinikverbund Kempten-Oberallgäu gGmbH
Kempten, Germany
Klinikum Konstanz
Konstanz, Germany
Zentrum für ambulante gynäkologische Onkologie am HELIOS Klinikum Krefeld
Krefeld, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
St. Vincenz Krankenhaus
Limburg, Germany
Klinikum Ludwigsburg
Ludwigsburg, Germany
UKSH Campus Lübeck
Lübeck, Germany
Universitätsmedizin Mainz
Mainz, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, Germany
UKGM Gießen/Marburg Standort Marburg
Marburg, Germany
Mühlenkreiskliniken, Johannes Wesling Klinikum Minden
Minden, Germany
LMU Klinikum München-Großhadern
München, Germany
Rotkreuzklinikum München
München, Germany
Universitätsklinikum Münster
Münster, Germany
Klinikum Neumarkt
Neumarkt, Germany
MVZ Nordhausen
Nordhausen, Germany
Ortenau Klinikum Offenburg-Kehl
Offenburg, Germany
St. Vincenz Krankenhaus GmbH
Paderborn, Germany
Studienzentrum Onkologie Ravensburg
Ravensburg, Germany
Krankenhaus Barmherzige Brüder
Regensburg, Germany
Klinikum am Steinenberg
Reutlingen, Germany
RoMed Klinikum Rosenheim
Rosenheim, Germany
Klinikum Südstadt Rostock
Rostock, Germany
Thüringen-Kliniken "Georgius Agricola"
Saalfeld, Germany
Leopoldina Krankenhaus Schweinfurt
Schweinfurt, Germany
g.SUND
Stralsund, Germany
Klinikum Stuttgart
Stuttgart, Germany
Klinikum Traunstein
Traunstein, Germany
Klinikum Mutterhaus
Trier, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinik Ulm
Ulm, Germany
St. Josefs-Hospital
Wiesbaden, Germany
Klinikum Worms
Worms, Germany
Related Publications (2)
Heitz F, Marth C, Henry S, Reuss A, Cibula D, Gaba Garcia L, Colombo N, Schmalfeld B, de Gregorio N, Wimberger P, Hasenburg A, Sehouli J, Gropp-Meier M, Schouten PC, Hahnen E, Hauke J, Polleis S, Harter P. AGO-OVAR 28/ENGOT-ov57. Niraparib alone versus niraparib in combination with bevacizumab in patients with carboplatin-taxane-based chemotherapy in advanced ovarian cancer: a multicenter randomized phase III trial. Int J Gynecol Cancer. 2023 Dec 4;33(12):1966-1969. doi: 10.1136/ijgc-2023-004944.
PMID: 37935524DERIVEDGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Philipp Harter, MD, PhD
KEM Essen | Evang. Kliniken Essen-Mitte gGmbH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 17, 2021
Study Start
September 13, 2022
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2031
Last Updated
September 10, 2025
Record last verified: 2025-09