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New combo therapy aims to keep ovarian cancer at bay longer

NCT ID NCT05009082

Disease control Sponsor: AGO Study Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 3 trial is testing whether adding bevacizumab to niraparib after standard chemotherapy helps women with newly diagnosed advanced ovarian cancer stay cancer-free longer. About 970 participants will receive either niraparib alone or niraparib plus bevacizumab as maintenance therapy. The study compares how long the cancer stays under control and monitors side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Niraparib and bevacizumab
What this could lead to
If successful, this combination could extend the time women with advanced ovarian cancer live without their disease worsening, offering a new standard treatment option.
What could go wrong
This is a large Phase 3 trial, but results may not apply to all ovarian cancer types. Adding bevacizumab also increases side effects like high blood pressure and bleeding risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 970 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. 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). 3. All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery. 4. 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. 5. Patients must be able to commence systemic therapy within 8 weeks of cytoreductive surgery. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 7. Estimated life expectancy \> 3 months. 8. 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) 9. 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. 10. Adequate liver and kidney function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2) * Total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) OR direct bilirubin ≤ 1.0 x ULN. * Aspartate aminotransferase / Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) and Alanine aminotransferase / Serum Glutamic Pyruvate Transaminase (ALAT/SGPT) ≤ 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be ≤ 5 x ULN. * Urine dipstick for proteinuria \< 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours. * Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 30 mL/min (see Appendix 2). 11. Patients must have normal blood pressure (BP) or adequately treated and controlled BP, with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 4 weeks prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2. 12. Negative urine or serum pregnancy test within 7 days prior to day 1, cycle 1 in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1. 13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 6 months after administration of the last dose of medication. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of \< 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. 14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other clinical trial procedures, that include the completion of patient-reported outcomes questionnaires. Exclusion Criteria: 1. Non-epithelial tumor origin of the ovary. 2. Ovarian tumors of low malignant potential (e.g. borderline tumors) and low grade tumors. 3. Planned intraperitoneal cytotoxic chemotherapy. 4. 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). 5. Prior systemic treatment for ovarian cancer. 6. Prior treatment with Poly adenosine diphosphate ribose polymerase (PARP) inhibitor. 7. 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). 8. Prior randomization in this trial. 9. 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. 10. 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. 11. Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab. 12. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to day 1, cycle 1. 13. History or evidence of thrombotic or hemorrhagic disorders within 3 months prior to day 1, cycle 1. 14. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures. 15. Pregnant or lactating women. 16. Treatment with any other investigational agent, or participation in another clinical trial testing a drug within 4 weeks or 5 times the half-life of the drug, whichever is longer, prior to day 1, cycle 1 or concomitantly within this trial. 17. Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary cell products or other recombinant human or humanized antibodies. Known hypersensitivity to niraparib, paclitaxel and carboplatin and its components or excipients. 18. Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no severe evidence of facial dehiscence or infection are eligible; regular wound examination will be performed. 19. Clinically significant cardiovascular disease, including * Myocardial infarction or unstable angina within 6 months of day 1, cycle 1 * New York Heart Association (NYHA) Grade 2 Congestive Heart Failure (CHF), * Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible) * Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activity of daily living (ADL) requiring repair or revision) * Significant vascular disease including aortic aneurysm requiring surgical repair 20. Pre-existing sensory or motor neuropathy ≥ Grade 2. 21. (Intentionally left blank) 22. Patients with a history of or current Nephrotic syndrome. 23. Persistent cancer-related bowel obstruction (including subocclusive disease). Patients with a known history of ileus, who have been successfully treated and who are free of symptoms, may be eligible after consultation of sponsor. 24. History of abdominal fistula or tracheoesophageal fistula or gastrointestinal perforation or active gastrointestinal bleeding or anastomotic insufficiency within 6 months of day 1, cycle 1. 25. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of niraparib. 26. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications. 27. Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 28. Previous allogeneic bone marrow transplant or previous solid organ transplantation. 29. Current or recent (within 10 days prior to day 1, cycle 1) chronic use of aspirin \> 325 mg/day. Patients treated with other inhibitors of platelet aggregation such as clopidogrel, prasugrel, ticlopidine, tirofibane or dipyridamole should not be included into the trial. 30. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits obtaining informed consent. 31. Patient has known active hepatitis B or hepatitis C. 32. Patient has a history of Posterior Reversible Encephalopathy Syndrome (PRES). 33. Patients with chronic inflammatory bowel disease and active treatment for disease control.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer fallopian tube neoplasm ovarian cancer ovarian carcinoma peritoneum cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fallopian tube cancer Ovarian cancer Peritoneal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    65 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albertinen Krankenhaus

    RECRUITING

    Hamburg, Germany

  • Florence-Nightingale-Krankenhaus Düsseldorf

    NOT_YET_RECRUITING

    Düsseldorf, Germany

  • Gyn.-onkolog. Gemeinschaftspraxis Hildesheim

    RECRUITING

    Hildesheim, Germany

  • Gynäkologisch-Onkologische Praxis am Pelikanplatz

    RECRUITING

    Hanover, Germany

  • Helios Klinikum Berlin-Buch

    RECRUITING

    Berlin, Germany

  • Hochtaunus-Kliniken

    RECRUITING

    Bad Homburg, Germany

  • KEM Essen | Evang. Kliniken Essen-Mitte gGmbH

    RECRUITING

    Essen, Germany

  • Klinikum Augsburg

    RECRUITING

    Augsburg, Germany

  • Klinikum Bremen Mitte

    RECRUITING

    Bremen, Germany

  • Klinikum Chemnitz

    RECRUITING

    Chemnitz, Germany

  • Klinikum Dortmund

    RECRUITING

    Dortmund, Germany

  • Klinikum Esslingen GmbH

    RECRUITING

    Esslingen am Neckar, Germany

  • Klinikum Frankfurt Höchst

    RECRUITING

    Frankfurt am Main, Germany

  • Klinikum Gütersloh

    RECRUITING

    Gütersloh, Germany

  • Klinikum Kassel

    RECRUITING

    Kassel, Germany

  • Klinikum Konstanz

    NOT_YET_RECRUITING

    Konstanz, Germany

  • Klinikum Ludwigsburg

    RECRUITING

    Ludwigsburg, Germany

  • Klinikum Mutterhaus

    RECRUITING

    Trier, Germany

  • Klinikum Neumarkt

    RECRUITING

    Neumarkt, Germany

  • Klinikum St. Marien Amberg

    RECRUITING

    Amberg, Germany

  • Klinikum Stuttgart

    RECRUITING

    Stuttgart, Germany

  • Klinikum Südstadt Rostock

    RECRUITING

    Rostock, Germany

  • Klinikum Traunstein

    RECRUITING

    Traunstein, Germany

  • Klinikum Worms

    RECRUITING

    Worms, Germany

  • Klinikum am Gesundbrunnen / SLK-Kliniken Heilbronn GmbH

    RECRUITING

    Heilbronn, Germany

  • Klinikum am Steinenberg

    RECRUITING

    Reutlingen, Germany

  • Klinikverbund Kempten-Oberallgäu gGmbH

    NOT_YET_RECRUITING

    Kempten, Germany

  • Krankenhaus Barmherzige Brüder

    RECRUITING

    Regensburg, Germany

  • LMU Klinikum München-Großhadern

    RECRUITING

    München, Germany

  • Leopoldina Krankenhaus Schweinfurt

    RECRUITING

    Schweinfurt, Germany

  • MVZ Nordhausen

    RECRUITING

    Nordhausen, Germany

  • Mammazentrum HH am Krankenhaus Jerusalem

    RECRUITING

    Hamburg, Germany

  • Mühlenkreiskliniken, Johannes Wesling Klinikum Minden

    RECRUITING

    Minden, Germany

  • Onkologische Schwerpunktpraxis Bielefeld

    RECRUITING

    Bielefeld, Germany

  • Ortenau Klinikum Offenburg-Kehl

    RECRUITING

    Offenburg, Germany

  • RoMed Klinikum Rosenheim

    RECRUITING

    Rosenheim, Germany

  • Rotkreuzklinikum München

    RECRUITING

    München, Germany

  • St. Elisabeth-Krankenhaus Köln-Hohenlind

    RECRUITING

    Cologne, Germany

  • St. Josefs-Hospital

    RECRUITING

    Wiesbaden, Germany

  • St. Vincenz Krankenhaus

    RECRUITING

    Limburg, Germany

  • St. Vincenz Krankenhaus GmbH

    RECRUITING

    Paderborn, Germany

  • Studienzentrum Onkologie Ravensburg

    RECRUITING

    Ravensburg, Germany

  • Städt. Klinikum Brandenburg

    RECRUITING

    Brandenburg an der Havel, Germany

  • Städtisches Klinikum Karlsruhe

    RECRUITING

    Karlsruhe, Germany

  • Thüringen-Kliniken "Georgius Agricola"

    RECRUITING

    Saalfeld, Germany

  • UKGM Gießen/Marburg Standort Marburg

    RECRUITING

    Marburg, Germany

  • UKSH Campus Lübeck

    RECRUITING

    Lübeck, Germany

  • Universitätsfrauenklinik Düsseldorf

    RECRUITING

    Düsseldorf, Germany

  • Universitätsklinik Ulm

    RECRUITING

    Ulm, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, Germany

  • Universitätsklinikum Essen

    RECRUITING

    Essen, Germany

  • Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt, Germany

  • Universitätsklinikum Gießen

    RECRUITING

    Giessen, Germany

  • Universitätsklinikum Halle

    RECRUITING

    Halle, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Germany

  • Universitätsklinikum Mannheim GmbH

    RECRUITING

    Mannheim, Germany

  • Universitätsklinikum Münster

    RECRUITING

    Münster, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, Germany

  • Universitätsklnikum Heidelberg

    RECRUITING

    Heidelberg, Germany

  • Universitätsmedizin Mainz

    RECRUITING

    Mainz, Germany

  • Universtitätsklinikum Jena

    RECRUITING

    Jena, Germany

  • ViDia Christliche Kliniken Karlsruhe

    RECRUITING

    Karlsruhe, Germany

  • Zentrum für ambulante gynäkologische Onkologie am HELIOS Klinikum Krefeld

    RECRUITING

    Krefeld, Germany

  • g.SUND

    RECRUITING

    Stralsund, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.